Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner Dietary Supplement packaged in 100 capsule containers.  Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid  in dietary supplements.
Thin and Slim Burn Fat Now Dietary Supplement packaged in 90 capsule containers.  http://www.secretsofherbs.com.  Made in the USA.
Thin and Slim Fataway Ultimate Stack with Chromium, packaged per 120 capsules.  Distributed by Dale H Enterprises Inc. Lewisburg, PA 17837, www.fataway.org.
The People's Chemist Thermo FX Barely Legal Thermogenic Aid, packaged in 90 capsule containers.  Manufactured by TPC, LLC, www.thepeopleschemist.com.
Black Widow 25 Ephedra Super Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
MetaPro 360 Metabolic Accelerator Dietary Supplement packaged in 120 capsule containers.  www.metapro360.com 877-778-7509.
The Store Thin and Slim Thermogenic Fat Burner Dietary Supplement packaged in 90 capsule containers. Distributed by The Store 2050 E. 6200 S., Holladay, UT 84121, The Store Holliday, 4695 S.Holladay Blvd, Holladay, UT 84117, The Store Midway, 42 W. Main Street, Midway, UT 84049.
Thin and Slim MaxOut Body Max Out FX Fat Burner with Ephedra packaged in containers of 60 capsules.  Distributed by Teamtrade, Inc., Ft. Lauderdale, FL. 1-866-MaxOut www.MaxOutBODY.com.
Asia Black 25 Ephedra Extreme Fat Burner Potent Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.
Thin and Slim Naturally The Natural Alternative AM Dietary Supplement packaged in 90 capsule containers. Distributed by TSN Labs Inc., P.O. Box 38, Midvale, UT 84047, 1-800-769-7290, www.tsn2000.com
Thin and Slim Extreme Stack Fat Burner Dietary Supplement packaged in 90 capsule containers.  TSN Labs Inc., P.O. Box 38, Midvale, UT 84047, 1-800-769-7290, www.tsn2000.com
Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusion, Must Be Diluted, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0719-06
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02
FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle  WWW.FUELUPPILLS.COM
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.
FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle  WWW.FUELUPPILLS.COM
Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd.  For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic
2 units were imported and distributed domestically
Individual bottles of product may produce weak beta-lactamase reactions.  Use may result in delayed or false negative reporting.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Sold via the firm's website and distributed by mail nationwide since at least November 2013 to March 2016.  No government/military consignees.
Yogurt Super Soynuts packaged in 16 oz. plastic bags and packaged in holiday tins. Lee Seed Company, Inc., Inwood, Iowa.
No lot code or expiration date are on the product labels/labeling.
Wylwood Fresh Frozen Broccoli Cuts, NET WT. 16 OZ  Code: A25335P and A15335P    Dist By: Save-A-Lot Stores, Earth City, MO.
Alimentos Congelados, S.A. (Pinula) is voluntarily recalling 1,800 cases of Frozen Broccoli Cuts because it has the potential to be contaminated with Listeria Monocytogenes,
U.S. distribution : Natrionwide. Foreign :Brazil, Canada, Chile, Colombia, Ecuador, Guatemala, Mexico, Oman, Peru, Taiwan, Turkey, United Kingdom and Uruguay.
The Plum A+ is a dual-line volumetric infusion system designed to meet the growing demand for hospital-wide, as well as alternate site and home healthcare, standardization. With its primary line, secondary line, and piggyback fluid delivery capability, the Plum A+ is suited for a wide range of medical/surgical and critical care applications. Full compatibility with LifeCare Plum Series administration sets and accessories.     Each system includes a pumping module (hereafter called the infuser) and an assortment of disposable IV sets (hereafter called a set), and optional accessories. The Plum A+ host device contains a Connectivity Engine peripheral module that provides wired Ethernet and wireless 802.11 a/b/g local area networking capabilities. This allows the Hospira Mednet networked application software to download drug libraries to the infuser and enable the autoprogramming  feature.
Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification metal cassette, resulting in an offset in proximal pressure.
The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver fluids over a broad range of infusion rates and is capable of Concurrent delivery from one or more rigid or flexible fluid containers. The Plum 360  infuser features Concurrent, Secondary, and Piggyback infusions. A positive valving cassette allows two lines to be delivered at independent rates. The volume to be infused (VTBI) is delivered through one line to a patient. The two lines can be delivered in Concurrent mode (together) or Piggyback mode (one after another) without raising or lowering I.V. bags. The Plum 360 infuser also enables fluid pathway troubleshooting such as removing proximal air in line, without is disconnecting the patient line.    The Plum 360 can act as a stand-alone infuser, or in conjunction with the Hospira MedNet software to provide medication safety software at the point of care, with customized drug libraries to support hospital defined protocols by  clinical care area. In such a configuration, the Plum 360 infuser can communicate with systems on the network via Ethernet or state of the art wireless communication using an 802.11 a/b/g/n/, 2.4 GHz/5 GHz dual-band radio. The Plum 360 infuser and Hospira MedNet software interface with other hospital systems such as Electronic Health records, Electronic Medication Administration Records, Bar Code Point of Care, Real Time Location Services, and there systems.    Each infuser includes a Connectivity Engine (CE) which provides both wired Ethernet and wireless 802.11 a/b/g/ networking capabilities. The Plum 360 infuser interfaces with Hospira MedNet application software to download drug library and infuser software updates and enable auto-programming of the infuser.The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
Henry Schein Single Use Syringe Luer-Lock, 10 mL, Intended for use by health care professionals for general purpose fluid aspiration/injection
BD 10 mL Syringe Luer-Lok Tip with BD PrecisionGlide Needle 21G x 1 (0.8 mm x 25 mm) and Henry Schein 10 mL Single Use Syringe Luer-Lock are being recalled due to possible adulteration and non-conforming manufacturing practices.
Henry Schein Single Use Syringe Luer-Lock, 10 mL,    Intended for use by health care professionals for general purpose fluid aspiration/injection
Nationwide, Puerto Rico and Foreign distribution to the following countries: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No. 10758750007110; IVD.
VITROS 5600: US: 1161 units, Foreign: 1063 units; VITROS 5600 Refurbished: US: 19 units, Foreign: 38 units
Ortho Clinical Diagnostics confirmed a software timing anomaly in which the VITROS 3600 and 5600 Systems may unexpectedly aspirate from or dispense into an unintended sample that may lead to erroneous or contaminated results.
VITROS 3600 Immunodiagnostic System, Catalog Number 6802783,for use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.
Software Version 3.2.2 & below; Serial Numbers J36000012 - J36000933.Unique Device Identifier No. 10758750002979, IVD.
Worldwide Distribution - US Nationwide including Puerto Rico and the countries of: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Eritrea, Ethiopia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Lebanon, Lesotho, Liberia, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mexico, Morocco, Mozambique, Myanmar, Namibia, Netherlands, New Zealand, Nigeria, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, Zambia, and Zimbabwe.
Cholesterol, Catalog No. OSR6x16    Product Usage:Cholesterol OSR6x16 is intended as a System reagent for the quantitative determination of Cholesterol concentrations in human serum on Beckman Coulter AU analyzers.
Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6X98, Lactate OSR6X93, and Lipase OSR6X30.
Lipase, Catalog No. OSR6x30    Product Usage:  Lipase OSR6x30 is intended as a System reagent for the quantitative determination of Lipase activity in human serum on Beckman Coulter AU analyzers.
Triglyceride, Catalog No. OSR6x118    Product Usage:Triglyceride OSR6x118 is intended as an Enzymatic colour test for the quantitative determination of triglyceride in human serum and plasma on Beckman Coulter AU analyzers.
Uric Acid, Catalog No. OSR6x98    Product Usage:Uric acid OSR6x98 is intended as a System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on Beckman Coulter AU analyzers.
Lactate, Catalog No. OSR6x93    Product Usage:  Lactate OSR6x93 is intended as a System reagent for the quantitative determination of L-Lactate in human plasma and cerebrospinal fluid (CSF) on Beckman Coulter AU analyzers.
U.S. distribution to the following; CA, CO, FL, IA, ID, IL, IN, MD, MN, MO, MS, NH, NJ, NV, NY, OK, SC, TX, UT, WA    No foreign distribution.
Nuvi Global  StemVitae   Multivitamin  30oz.
Undeclared whey protein which contains the allergens of milk and soy lecithin.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
7-Eleven Fresh To Go Sugar Cookie made with M&M (R) Chocolate Candy  Net Wt  4.0 oz  (114g). Manufactured by Bakery Express in Orlando, FL.
7-Eleven Fresh To Go Peanut Butter Cookie  Net Wt 4.0 oz  (114g).  Manufactured by Bakery Express in Orlando, FL.
US, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colunbia, Croatia, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay
CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS packs due to the possible presence of a molding irregularity found within the aspiration luer which may result in a reduction of vacuum within the aspiration line.
Surgical Table Cushion (HybriGel Pads)  HybrGel Pads are an optional accessory to the Operon Surgical Table. The pads may be attached to the base section with a Velcro fastener. The HybriGel pad shapes and variants can differ depending on the scope of the delivery.
The Surgical Table Cushion (HybriGel Pads) could potentially contain staples that's secure two underlying fabrics, which would be captured on certain scans on patients, such as x-ray.
Nationwide Distribution to CA, FL, IL, KY, NY, PA, VA and Puerto Rico
4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297  VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is suitable for the analysis of blood glucose and lactate
The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride and potassium oxalate), which can effect analytical results for glucose and lactate.
7-ELEVEN FRESH TO GO SUGAR COOKIE WITH M&M CHOCOLATE CANDY, 2 pieces, NET WT. 4 OZ. The affected cookies are packed in a clear, plastic film, two cookies per package.
DOUGH MASTERS WHOLESALE BAKERY of Warren, MI. is recalling select 7-ELEVEN FRESH TO GO brand cookies because they may contain undeclared allergen peanuts resulting from a supplier's recall.
Best By dates codes: Friday 0422, Saturday 0423, Sunday 0424, Monday 0425 on the front label; UPC 052548558765 Manhattan UPC: 052548558765.
distributed in AK, CA, CO, CT, ID, KS, MA, MN, MT, NJ, NM, NV, NY, OK, OR, SC, TX, VA, WA.
360/2.25 oz. packages and 31,068/6oz. packages
Werner Brand Butter Toffee Peanuts are recalled because the labels declared butter, but milk is not declared.
24,318/6 oz. packages and 252/2 oz. packages
Werner Brand Sweet Hot Crunch Mix is recalled because label declared butter, but milk is not declared.
US Distribution to states of: AL, AZ, CO, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NY, NC, OK, PA, RI, TX and UT.
Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated.    A tracheal tube is inserted into a patients mouth or nose for airway management.
The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube.
Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only,  Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7703-21
Nationwide Distribution to DE, NC, CA, OK, PA, SC, WI, CO, NJ, TX, UT, IL, MO, MI, AL, KS.
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System.  1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template.    Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
Labeling errors.  The outer packge label expiration date may exceed the expiration date of the subcomponents.
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System.  1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template.    Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System.    1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template.    Intended for use in fracture repair and reconstructive procedures of the craniofacial skeleton in pediatric and adult populations.
Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators.    Used to treat chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.
Loss of therapy during recharging of device. Reportedly, a charging session was terminated prior to obtaining recharge threshold voltage of 3.615, which triggered rapid battery depletion state. As a result, the device depleted to 1.925 volts in one to two days rather than the typical 30 days. Insufficient coupling between recharger and device during recharge session was found to be key factor.
All lot/serial numbers are affected for both Model numbers 37714 and 97714.
US: WA, NJ, MD, CA, IL, GA, TX,     Canada.
Noodles with Beijing Style Black Bean Sauce, 23.3oz, UPC 7 53214 30024 3, Food Item No. 30024, Pack Size: 16.
Pulmuone Foods is recalling noodles because it contains undeclared milk.
Korean Noodles in a Savory Black Bean Sauce, 46.6oz, UPC 7-53214-73298-3, Food Item No. 1027557, Pack Size: 8.
Noodles with Fire-roasted Black Bean Sauce, 23.3oz, UPC 7 53214 30021 2, Food Item No. 30021, Pack Size: 16.
Stryker FlowPort II Adapter: Model number: 00CAT00778   The FlowPort II Adapter is intended to connect the FlowPort II Cannulas to commercially available, 4mm arthroscopes in surgical procedures.
Complaints were received for the Stryker FlowPort II Adapter, and investigation found that the scope sat in the adapter 180 degrees in the wrong direction
DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument.  Part number 351.43
Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions.  The high growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points.  This could potentially be reproduced during use and reprocessing.
USA (nationwide) Distribution to the states of :   ( DuraDiagnost) to the states of :  OH, CA, WA and NE.    (DigitalDiagnost) to the states of : AK, AZ, AL, CA, CT, CO, DE, FL, GA, HI, ID, KY, LA, MA, MN, MD, MS, ME, MO, NE, NY, ND, OH and PA.
Philips Healthcare DigitalDiagnost stationary X-ray system
The detector may signal that it is ready for acquisition  when it actually is not, resulting in failure to properly acquire the X-ray image.
Philips Healthcare DuraDiagnost stationary X-ray system
The firm shipped the product to 10 customers. All customers were Aldi distribution centers.
Aldi's Millville protein chew bars, dark chocolate peanut butter packaged 5 bars to a box in a yellow and brown box with brown and white lettering.
A supplier of one of the ingredients in the protein chewy bars informed firm of Listeria Monocytogenes positive.
Aldi's Millville protein chew bars, peanut, dark chocolate & almond packaged 5 bars per box in a yellow and brown box with brown and white lettering.
Shipped to bass pro shops across the united states. See attachment in email for a list of consignees.
packaged in a clear 3 oz plastic bag with attached green and orange label with yellow and black writing. item number: 7339, UPC # 752545073390.
Ingredient in the trail mix, may be contaminated with Listeria  Monocytogenes
US Distribution - TX, OH, NY, MD, IN, PA, DE, WA, NH, AZ, GA, NC, UT, VT, CA, LA, NJ, MN, FL, WI, HI, IA, MA, ME, TN, CT, ID, MI, AR and KS.
Sedecal SA Mobile Diagnost w DR x-ray system
was selected and is displayed in the generator control area of the Eleva User Interface.
Worldwide and US Nationwide Distribution   AE, AO, AR , AT , AU , AZ , BD , BE , BG , BH , BM , BN , BR , CA , CH , CL , CN , CO , CS , CZ , DE , DK , EG , ES , FI , FR , GB , GR , HK , HR , HU , ID , IE , IL , IN , IR , IS , IT , JO , JP , KR , KW , LB , LI , LK , LT , LU , LV , LY , MA , MT , MX , MY , NL , NO , NZ , OM , PH , PK , PL , PT , QA , RO , RS , RU, SA , SE , SG , SI , SK , SY , TH , TN , TR , TW , UA , US , UY  and  ZA.
The center bolt of the sling bar, which connects the bar to the patient lift, has failed during use.   If the sling bar is not used as intended the bolt may be weakened. If the bolt is weakened there is a potential risk for breakage with the result of a free fall of the patient. This hazard could cause potentially minor to catastrophic injuries to a patient.
Worldwide Distribution: United States: Nationwide (including Puerto Rico) and countries of: Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, Great Britain, Ireland, Italy, The Netherlands, Norway, Sweden, Slovenia, Czech Republic, Kuwait, Mexico, Brazil, Australia, Taiwan, and New Zealand.
Actifuse ABX/Actifuse MIS System     A bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.
Baxter Healthcare is issuing a voluntary recall for all lots of Actifuse ABX and Actifuse MIS System products with expiry before July 29, 2017 due to the possibility that the products may have endotoxin levels above specification criteria.
Product Code: 506005078050  Lot #: All  Expiration Date: August 01, 2015 - July 29, 2017    Product Code:506005078051  Lot #: All  Expiration Date: August 01, 2015 - July 29, 2017    Product Code:506005078052  Lot #: All  Expiration Date: August 01, 2015 - July 29, 2017    Product Code:506005078058  Lot #: All  Expiration Date: August 01, 2015 - July 29, 2017    Product Code:506005078060  Lot #: All  Expiration Date: August 01, 2015 - July 29, 2017    Product Code:506005078070  Lot #: All  Expiration Date: August 01, 2015 - July 29, 2017    Product Code:506005078072  Lot #: All  Expiration Date: August 01, 2015 - July 29, 2017
Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany, NJ 07981 --- NDC 11523-7391-1, UPC 00041100005762
Labeling; Product Contains Undeclared API (Oxybenzone)
Sure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T   The product is used as an aid in the identification of Staphylococcus aureus from Culture
Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures.
Distributed to the following states: AL, FL, GA, NC, SC, TN
Publix Cranberry Nut & Seed Mix, 7.05 ounce plastic container.  Manufactured by Publix Supermarkets in Lakeland, FL.
Possible contamination of Listeria monocytogenes.
Worldwide Distribution -- US, including the states of AK, AL, AZ, CA, FL, GA, HI, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WI;     Foreign: Australia, New Zealand, Korea,  Austria, Belgium, Germany, Italy, France, Luxembourg, Netherlands, South Africa, Spain, Sweden, Switzerland, and United Arab Emirates.
Tibial Plate Instruments and Modular Brackets, due to incidents of radiolucent lines and loosening in implants.
US Distribution - AZ, PA, FL, DC, W VA, NC, SC, AR, OK, OH, NY, NV, TX, PA, IN, CA, MN, MA, DC, MS, MD, OR, IL, CO, MO, VT, IA, AL, LA, GA and WA.
Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of view; (4) DoseRight algorithm miscalculations leading to incorrect CTDI values; (5) scan length changes during subsequent axial results, (6) surview scan lengths near 135mm or 184mm
Philips Healthcare Ingenuity Core Computed Tomography X-Ray System
Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System
Philips Healthcare Ingenuity CT Computed Tomography X-Ray System
Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System
Philips Healthcare Brilliance iCT SP  Computed Tomography X-Ray System
Philips Healthcare Brilliance 64 Computed Tomography X-Ray System
One consignee in Colorado. No foreign or VA/govt/military consignees.
24 oz RM German Choc. Dessert Bar Cake. Net Wt: 24 oz, K Dairy, UPC 752716883308, Vollmer's Bakery - 4004 Grape Street - Denver, CO - 303-388-8393. Packaging: Plastic Container, 8 per case, Keep frozen, refrigerate after opening.
Frozen Inc is recalling 24 oz RM German Chocolate Dessert Bar Cake because it does not list pecans.
Blood product, collected from a donor who disclosed travel history to a malarial endemic area, was distributed.
Stryker Instruments Div. of Stryker Corporation
Domestic only:   AL  AR  CA  FL  GA  IL  IN  KS  KY  MD  MI  MO  NC  NM  OH  OK  SC  TN  TX  VA  WA  WI
Maestro Air Motor  Pneumatic cranial drill motor.   The Maestro Air Pneumatic System is a pneumatically operated surgical instrument system.  The pneumatic motor provides power to operate removable rotating surgical cutting tools and their accessories.
Due to the buildup of grease within the hose and motor, there is an increased likelihood that the product may require  multiple attempts to start. In addition, there is a possibility that the grease may migrate into the attachment end of the  motor.  Risk to Health:  Although there have been no reported incidents, there is a negligible possibility that the orange grease may leak from  the attachme
Worldwide Distribution - Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, UT, VA, VT, WA, WI, WV, WY and Internationally to Canada...
Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S  Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.
DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the Norian Drillable Injects-Sterile due to the rotary pouch within the referenced lots and associated part numbers may potentially be labeled with the incorrect powder volume/size; however, the rotary pouch contains the correct powder volume/size according to the outer label.
Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S  Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.
Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S  Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.
Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490    Product Usage:  The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.
VS203 Lot# MBZX140 (100 units); VS303 Lot # MBZL450 (60 units); VS303 Lot # MBZV930 (65 units); VS303 Lot # MBZZ490 (33 units).
This recall has been initiated due to the product labeled with the incorrect expiration date.
US: FL, IL, KS, MI, MN, MO, NE, ND, PA, SD, WI.
Karlsburger, Mesquite Seasoning Mix & Marinade, Item 46402, Net WT 2 lbs in plastic shaker jars.
Karlsburger Foods Inc., is recalling 2 lb containers of Mesquite Seasoning Mix because it contains  an undeclared allergen, soy.  Product not sold to retail.
QUAD-MIX #2, packaged in 5mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
METHYLCOBALAMIN 1 MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID- 5%/4.75%, packaged in 10mL vials, Rx only,  Well Care Compounding Pharmacy Las Vegas, NV 89121
TRI-MIX # 1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL vials, Rx only,  Well Care Compounding Pharmacy Las Vegas, NV 89121
METHYLCOBALAMIN 5MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
VITAMIN B COMPLEX # 3, packaged in 5mL vials, Rx only,   Well Care Compounding Pharmacy Las Vegas, NV 89121
SUPER TRI-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
TRI-MIX # 5, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
M.l.C./B5/B6  25 MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
TESTOSTERONE CYPIONATE  10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
PHENYLEPHERINE 0.5%, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
TESTOSTERONE CYPIONATE  200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV
TESTOSTERONE CYPIONATE  150MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
ESTRADIOL VALERATE 10MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy   Las Vegas, NV 89121
TESTOSTERONE CYPIONATE  175MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
METHYLCOBALAMIN 12.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
QUAD-MIX #4 (MOD), packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
TRI-MIX # 4, packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
MYERS' COCKTAIL, packaged in 37 mL vials, Rx only,  Well Care Compounding Pharmacy Las Vegas, NV 89121
ESTRADIOL VALERATE 20MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
ITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
ALPHA LIPOIC ACID 25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
TESTOSTERONE CYPIONATE  100MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
METHYLCOBALAMIN/FOLIC ACID; 10MG/0.8MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
LEVOCARNITINE 100MG/ML, packaged in 5mL vials, Rx only,  Well Care Compounding Pharmacy Las Vegas, NV 89121
ESTRADIOL VALERATE 40MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
17-0H PROGESTERONE 250MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
VITAMIN B COMPLEX # 1; packaged in 5mL vials, Rx only,   Well Care Compounding Pharmacy Las Vegas, NV 89121
QUAD-MIX #1, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
VANCOMYCIN 50MG/ML OPHTH SOLUTION; packaged in 10mL vial, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
M.I.C. /MB12/B6/DEXPLAN/L-CARN, 25MG/50MG/25MG/10MG/10MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
ITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY;  30 mL Spray, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
SUPER TRI-MIX #4, packaged in 5mL vials, Rx only,   Well Care Compounding Pharmacy Las Vegas, NV 89121
TRI-MIX # 6, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
M.l.C. Methyl B12, 25 MG/50MG/25MG/1 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
1-HCG 2000 IU/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
GENTAMICIN 15 MG/ML Ophthalmic Solution, Sterile Droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
TRI-MIX # 3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
MB 12/HXB 12/FA/P5P/(LIDO 0.1 %), 2MG/2MCi/20MG/6.5MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
GLUTATHIONE 100MG/ML, packaged in 10 mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121
1-HCG 1000 IU/ML, packaged in 5mL and 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Hydrogen Peroxide 3%, packaged in 10mL bottles, Rx only,   Well Care Compounding Pharmacy Las Vegas, NV 89121
TRI-MIX # 2, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
L-GLUT/L-ARG/L-CARN; 25MG/100MG/200MG/ML, packaged in 5mL vials, Rx only,  Well Care Compounding Pharmacy Las Vegas, NV 89121
M.l.C. 25MG/50MG/25MG/ML, packaged in 5mL vials, Rx only,   Well Care Compounding Pharmacy Las Vegas, NV 89121
GLUTATHIONE 200MG/ML, packaged in 5mL vials,   Well Care Compounding Pharmacy Las Vegas, NV 89121
QUAD-MIX #3, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
Nationwide Distribution to the states of : NJ, PA, MI, CO, CA, FL, OK, NY, NH, CT, AZ and MO.
Ellipse ND: YAG Laser applicator for Ellipse Multiflex    Medical Laser Products.
Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
Ellipse ND: YAG Laser applicator for Ellipse Nordlys system    Medical Laser Products.
Worldwide Distribution: US (nationwide) including states of: AL, CA, CT, FL, GA, HI, IL, IN, KS, NE, NY,NC, OH, OR, PA, TN, TX, UT, A, WA, WI; and countries of: Australia, Belgium, Brazil, Canada, China, Denmark, Estonia, France, Germany, Hong Kong, Indonesia, Italy, Japan, Korea (Republic of), Kuwait, Mexico, New Zealand, Norway, Peru, Poland, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, and United Kingdom.
GE Revolution CT    The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications. The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data from the same axial plane taken at different angles.
GEHC has become aware of a potential safety issue in the Revolution CT Patient Table that can result in unintended motion in cases involving large patients. The Revolution CT cradle can descend on its own after activation by the user. This can put the patient at risk for harm. The harm can involve the impinging or crushing of a hand if caught between the cradle and CT inner gantry bore. No injurie
Central Texas Regional Blood & Tissue Center
Platelet products, labeled as leukoreduced, which did not meet leukoreduction criteria, were distributed.
Blood product, collected from a donor who did not meet eligibility criteria, was distributed.
U.S. distribution to the following; GA, AZ, MA, CA, CO, WA, NY, MI, TX, ME, LA, PA, FL, MS, TN, KY, NC, OH, WV, OR, WI, IL, VT, DC, MI, KS. MO, NJ, OK, RI, AL, CT,    Foreign distribution to the following; Canada, Argentina, Bosnia, Brazil, Bulgaria, Chile, China, Costa Rica, Cypris, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, Greece, Guatemala, Hungary, India, Indonesia, Israel, Italy, Japan, Jorda, Korea, Kuwait, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, Pakistan, Panama, Peru, Philippines, Poland, Qatar, Romania, Russiam Saudi Arabia, Serbia, Singapore, Slovakia, Sri Lanka, Thailand, Trinidad, Turkey, UAE, United Kingdom, Uruguay, Vietnam
HLA test kits, which may be associated with false negative reactions, were distributed.
Signature TKA GDE/MDL Set 04-05    Patient-specific surgical guide and instrument set.
A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case.  If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used.
US: AL, AZ, CA, CO, FL, ID, IL, IA,ME, NE, NV,NH, NJ, NY, NC, OH, PA, SC, SD, TN, TX, UT,VA, WA, WI.      OUS:  Argentina  Australia  Austria  Brazil  Canada  Chile  Colombia  Denmark  Egypt  Finland  France  Germany  Greece  Hong Kong  Iceland  Italy  Japan  Korea (Republic of)  Kuwait  Malaysia  Netherlands  Norway  Peru  Poland  Portugal  Russia  Singapore  South Africa  Spain  Sweden  Switzerland  Ukraine  United Arab Emirates  United Kingdom
Optima 1.5T MR430s MR Scanner, a diagnostic imaging device
The gas venting may not occur properly.  A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.
MSK 1.5T Extreme MR Scanner, a diagnostic imaging device
It was discovered during post-quarantine packaging on 2/16/2016 that the IFU for the STATLOCK Sheath Stabilization device for Percutaneous Sheath Introducer (Vendor PN 2403097-1405R) was erroneously packaged with the Mega and Sensation Plus IAB Catheter Kits instead of the IFU for the  STATLOCK Catheter Stabilization device for IAB catheters (Vendor PN 24030905-1406R).
Two batches of Prothrombin Complex Concentrate (Human), not meeting incoming material specifications, were distributed.
Blood Systems, Inc. dba United Blood Services Texas
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Distributed in the states of Florida, New York, Texas and Ohio, and in the countries of Belgium, France, Germany, Italy, Japan and South Korea.
ExacTrac Vero is a Patient Positioning System for Radiation therapy.
Potentially incorrect positioning when using Implanted Marker Detection with Brainlab ExacTrac Vero 3.5
Potentially affected is ExacTrac Vero version 3.5 (including all subversions). Serial numbers/lot numbers are not applicable for a software version.    Model/catalogue numbers:     20892 EXACTRAC VERO SOFTWARE 3.5  20892A EXACTRAC VERO SOFTWARE 3.5.1  20892B EXACTRAC VERO SOFTWARE 3.5.2  20892C EXACTRAC VERO SOFTWARE 3.5.3  20893 VERO INFRARED POSITIONING/MONITORING SW  46213 EXACTRAC VERO SW UPDATE 3.5 TO 3.5.1  46214 EXACTRAC VERO UPGRADE KIT 3.2 to 3.5 FOC  46215 EXACTRAC VERO UPGRADE KIT 3.1 TO 3.5 FOC  46216 EXACTRAC VERO SW UPDATE 3.5.2 TO 3.5.3  46228 EXACTRAC VERO 3.5 ROW  46238 EXACTRAC VERO 3.5 JAPAN
AL, CA, IL, IN, IA, MA, MN, NJ, NY, NC,  PA, RI, UT, VA, WA and WI.
Honest Kids-Super Fruit Punch, Organic Juice Drink, 59 fluid oz. bottle, 006 57622 41273 7, Honest Tea, Inc., 4827 Bethesda Ave., Bethesda, MD 20814.
The label does not list apple juice ingredient present in the beverage.
Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN  38141, NDC 61553-836-11, Service Code 2K5836.
Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride.
CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only.  MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01.
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.