Platelets Pheresis Leukocytes Reduced Irradiated
Blood product, collected from a donor who disclosed taking  a daily dose of Aspirin , was distributed.
Blood product, manufactured from an overweight whole blood unit, was distributed.
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Blood product, which did not have the correct amount red cell preservative solution added, was distributed.
Blood and Blood Products for Reprocessing
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood product, which tested as CMV positive but labeled as CMV negative, was distributed.
Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
University of Texas Medical Branch at Galveston (The)
Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed. .
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
Blood products, with positive bacterial detection testing, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated
Blood products, which were possibly contaminated, were distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was  distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood product, which was collected from a donor who was taking the medication Finasteride, was distributed.
Blood products, which were not quarantined after receiving post donation information regarding an undocumented piercing, were distributed.
Community Blood Center of Greater Kansas City
Blood products, collected from a donor with a history of living with an individual diagnosed with Hepatitis B, were distributed.
Blood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Blood products, collected from donors who did not have a complete physical examination, were distributed.
Blood products, collected from a donor with a history of incarceration, were distributed.
Blood products, collected from donors who were previously deferred for high risk behavior, were distributed.
Blood products, collected from a donor who was previously deferred, were distributed.
Blood products, for which the sterility may have been compromised, were distributed.
Worldwide Distribution-USA (nationwide) and the countries of  Austria, Belgium, China, Germany, Spain, France, United Kingdom, Italy, Pakistan, Poland, Russia, Slovakia, Taiwan, and South Africa.
Brand Name: RX Accunet Embolic Protection System Common Name: RX Accunet EPS.    Part Numbers: 101649-45, 1011649-55, 1011649-65, 1011649-75, 1011650-55, 1011650-65, 1011651-45, 1011651-55.    The RX Accunet EPS is indicated for use as a guide wire and embolic protection system.
1253 units (962 units in the US & Puerto Rico)
The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX Accunet Embolic Protection System may exhibit difficult removal of the peel away sheath due to higher than normal wall thickness.
Worldwide Distribution - USA including AL, CT, FL, IL, MA, MO, NJ, NY, PA, TX VA, WA, WI and Internationally to TURKEY, TAIWAN, SWITZERLAND, SWEDEN, SOUTH AFRICA,  NIGERIA, MALAYSIA, KOREA, JAPAN, INDIA, GERMANY, FRANCE, EGYPT, DENMARK, CHINA, CHILE, CANDA, BRAZIL, AUSTRIA, and GREAT BRITAIN.
AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 5160092-3 Version 7.5,  5160092-4 version 7.6.
It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated.   A second issue was discovered internally in which the Interpolation in Advantage Sim MD 7.5 would not give a correct result when some part wee removed from an existing structure.  If the contour truncation is not recognized, it may lead to inappropriate irradiation of the patient.
Motorola Solutions  PCS3000/CS3070 Laser   Utility/Peripheral Laser Products
It was discovered the CS3000/CS3070  was manufactured using the laser power settings for a Class 2 laser device instead of the Class 1 power levels as specified on the product label.
Rectal Retractors, stainless steel, item # AL07289000, a component of  Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
A medical device used in brachytherapy may become contaminated and can cause infections, toxicity or allergic reactions.
Rectal Retractors, titanium, item # AL07368000, a component of  Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.
Worldwide Distribution and US Nationwide in the countries of  (Germany, Sweeden, Croatia, Lithuania, and Dubai).
Infinity Enteralite Ambulatory Feeding Pumps, List number: INFKIT2 - Addendum to Operator's Manual    Product usage: provide a means for the volumetric delivery of fluids used in Enteral applications.
The firm is adding an addendum to the operator's manual for Infinity Enteralite Ambulatory Feeding Pumps pertaining to the Infinite Dose mode and the inability of the Pump to detect air in line.
Community Blood Centers of Florida, Inc.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Blood product, which tested negative for viral markers, but was collected from a donor that subsequently reported a previous history of positive test hepatitis, was distributed.
Blood product, which did not meet acceptable product specifications, was distributed.
Blood product, which was collected from a donor who had lived in a malarial endemic area, was distributed.
Mindray DS USA, Inc. d.b.a. Mindray North America
US Nationwide Distribution including the states of: VA, TN, FL, & TX
Mindray, DPM5 Monitor, a vital signs monitor used on human patients in healthcare facilities.
Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.
Worldwide Distribution -- Nationwide Distribution including the states of AR, AZ, CA, FL, GA, IL, IN, MD, MT, NC, NE, NH, NJ, NY, OH, PA, TN, TX, WI and WA.
Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Orthopedic implant.
Catalog Number 101-00010 Lot number AP3V12 AP4E01 AP4N04 AP5E25 AP6A44 AP6E42 AP6L14 AP6M17 AP6T08.
Lag screw measurement is short (approximately 5 mm) when using current screw measuring device (p/n 101-00010) per the IO FIX Surgical Technique Rev C. which can lead to possible inappropriate implant size selection (e.g. shorter screw size selected).
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals
Hydrocodone bitartrate and acetaminophen Tablets, USP, 10 mg/500 mg, packaged in a) 30-count bottles, NDC 0603-3888-16; b) 60-count bottles, NDC 0603-3888-20; c) 90-count bottles, NDC 0603-3888-02; d) 100-count bottles, NDC 0603-3888-21; e) 120-count bottles, NDC 0603-3888-22; f) 150-count bottles, NDC 0603-3888-26; g) 180-count bottles, NDC 0603-3888-04; h) 500-count bottles, NDC 0603-3888-28; and i) 1000-count bottles, NDC 0603-3888-32, Rx only, Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811.
Superpotent (Multiple Ingredient) Drug: Complaint received of oversized tablets.
US  (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Hawaii.
Cordis, a Johnson and Johnson Company, ExoSeal(TM)  6F  Vascular Closure Device  REF cat. No EX500, EX600, and EX700. Used for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional procedures.
On 10/29/2012 Cordis Corporation, Miami Lakes, FL initiated a recall of their Cordis ExoSeal (TM) Vascular Closure Device.  Affected lots of Cordis ExoSeal (TM) VCD have been sterilized using a process that did not achieve the sterility assurance level that is required by the standards of this class of product.  Model Numbers EX500, EX600, and EX700.
AZ, CA, HI, ID, MT, OR, UT, WA   GUAM, AMERICAN SAMOA, MEXICO, SINGAPORE, PAPUA NW GUINEA.
Betty Croker, Super Moist Cake Mix, Golden Vanilla, NET WT 15.25 oz (432 g), UPC 0 16000 40993 4, Dist by General Mills Sales, Inc., Minneapolis, MN 55440.   Case UPC code  1600040993000
Consumer package code:   Better Used By 14SEP2013    Case code:     14SEP3LD
6223 cases (12 consumer packages / case)
General Mills is recalling a limited quantity of Betty Crocker SuperMoist Golden Vanilla cake because of a labeling issue.  Some product was packaged incorrectly, and contains undeclared FDandC color ingredient not listed on the box's ingredient label.  The undeclared colors are: Yellow 5, Yellow 6, Red 40 and Blue 1.
Worldwide Distribution - USA (nationwide) and the countries of Canada and Cayman Islands
Alfa Wassermann System Diluent 750 mL   Manufactured for Alfa Wassermann Diagnostic Technologies LLC 4 Henderson Drive West Caldwell, NJ 07006    Alfa Wassermann B.V. Pompmolenlaan 24   3447 GK, Woerden The Netherlands    Common name is water solution. Intended to dilute reagents and rinse the parts of a clinical chemistry instrument.
Inorganic phosphorus assays using System Diluent Lot 155599 may not product acceptable calibration results.
US Nationwide Distribution including the states of AL, CA, CO, CT, IL, MD, MI, MO, NY,  OH, PA
Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920    Product Usage:  Universal R/F, general use
Values of fluoroscopy time, Air Kerma Rate and Cumulated Air Kerma may not be displayed ''at  the fluoroscopist's working position'' as per 21 CFR 1003.21
Worldwide Distribution-USA including the states of AL, AZ, CA, CT, FL, GA, IL, MA, MI, MN, NC, OK, RI, and TX, and the country of GERMANY.
Esteem Programmer Model 6001, US and ISA, Model 3001 Dell E54XX. Part of the Esteem Totally Implantable Hearing System.  The ISA and Commander are software packages that run on a laptop personal computer.
Envoy Medical is conducting a voluntary correction of a limited number of Esteem Programmers, part of the Esteem Totally Implantable Hearing System, to reduce their susceptibility to noise interference.
Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033
Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.
Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea.
Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769   Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Assayed quality control material for use with the Alere Cholestech LDX System.
Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control (MAC) and the Alere Cholestech LDX Calibrator Verification, 4 vial set, because of issues with increased HDL Cholesterol results.
Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770   Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), and glucose (GLU) test procedures on the Alere Cholestech LDX System. Calibration verification is optional for CLIA waived systems, such as the Alere Cholestech LDX System, under CLIA regulations. However local or state regulations may require that calibration verification is run at regular intervals.
Worldwide Distribution, including Nationwide (USA) and the countries of AU, GM, FR, IT, SP, BR, BM, AR, CA, JA, MX, UK, CH, CL, CO, IN, EC, PE, PY, PA, PT, NZ, SG, VE and UY.
Ortho Clinical Diagnostics VITROS Chemistry Products Vapor Adsorption Cartridge  REF/CAT No. 680 0100.  VITROS Vapor Adsorption Cartridges are used to remove vapor contaminants that may potentially interfere with Signal Reagent used with MicroWell Assays on the VITROS 3600, VITROS 5600, and VITROS ECi/ECiQ Systems.
CAT No. 680 0100; the cartridges do not have lot numbers.
Some VITROS Chemistry Products Vapor Adsorption Cartridge CAT No. 6800100 cartons incorrectly contain a Particulate Cartridge Part No. J19612. In some instances, the Particulate Cartridge has been inadvertently installed on the VITROS System instead of the intended VITROS Vapor Adsorption Cartridge which may bias results.
DOMESTIC: Arkansas, California, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Texas, Washington, and Wisconsin   INTERNATIONAL: Trinidad and Tobago
Individual packages labeled in part: ***The Father's Table***Vanilla Roll***8oz**** and Master carton labeled in part: ''The Father's Table***Shelf Stable*** Mini Vanilla Roll***Contains 12/8oz.***
Incorrectly labeled with a label that does not list strawberries and color additives (FC&C Red 40 and Blue 1).
Individual packages labeled in part: ***The Bakery baked with pride***Vanilla Mini Cake Roll***8oz**** with strawberry filling*** NETWT 8oz (226g)
JFC International is recalling WelPac Saki Ika Cuttlefish because of mold.
Product was distributed in Arkansas California, Florida, Georgia, Indiana, Michigan, Minnesota, New Hampshire, New Jersey, New Mexico, New York, Oregon, Virginia, Washington, West Virginia, Wisconsin,
Chocolate Covered Coconut Balls is packaged in either 2-ounce packages (2 pieces per package)  or in 0.5 lb and 1 lb. boxes.   The 2-ounce package has a UPC 19815 90007 8.  There is no UPC for 0.5 lb. and 1 lb. packages.    The product is labeled in parts: ''***Chocolate Covered Coconut Balls***CHOCOLATE DECADENCE***Net Wt. 2oz (56.7g)***INGREDIENTS: Semi-sweet chocolate (sugar,
46/2 oz. packages; 5/1 lb. boxes; and 2/0.5 lbs boxes
There is a potential of cross contamination with peanuts. The Chocolate Covered Coconut Balls were dipped in the same pot of melting chocolate that was used to make product containing peanut butter.
Jerusalem Manufacturing Natural Foods & Wholesalers, Inc.
Kinnikinnick Foods Brand Frozen Pie Crusts, 290g/10 ounces. 2 crusts per box, 6 boxes per case
Product code 620133006009 and lot BB2013DE13
Kinnikinnick Foods Inc., a Canadian manufacturer notifed Jerusalem Manufacturing Natural Food and Wholesalers, Inc. in Dearborn, MI to recall the Kinnikinnick Foods Brand Frozen Pies, 290g/10 ounces. 2 crusts per box, 6 boxes per case due to EGG not declared on the label.
Worldwide Distribution - Foreign (22 EU countries - Austria, Belgium, Bulgaria, Croatia, Cypress, Czech Republic, Denmark, Germany, Finland, France, Greenland, Hungary, Iceland, Italy, Luxembourg, Netherland, Norway, Sweden, Switzerland, Spain, Turkey, UK); (41 Rest of World countries - See Attachment for full country distribution + Japan, Portugal and Mexico)
COBAS TaqMan Mycobacteria tuberculosis (MTB)  Test FOR IN VITRO DIAGNOSTIC USE.
Material Number: CE-IVD: 04803531190 Kit, 05574455190 TDF; JPN-IVD: 04653360190 Kit, 05574447190 TDF. Lot/Serial Number: CE-IVD: All Kits, JPN-IVD: All Kits.
The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test Kits, both CE-IVD and JPN-IVD, have an incorrect Target Elbow Max cutoff value of 48 creating the potential for false negative results to be generated for patient samples with Target Elbows in the range of 48 to 50.
Worldwide Distribution - USA including CA, FL, IL, AL, OH, KY,  TX , and Internationally to Australia, Columbia, Mexico, Netherlands, and Chile.
TUNNELOC ROUND HEAD INTERFERENCE SCREW 8MMX25MM  Biomet Sports Medicine manufactures a variety of internal fixation devices intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease. Implants used for this application include: screws, washers, anchors, pins, and suture. Interference Screws and Set Screws are intended for use in fixation of patellar bone-tendon-bone grafts in ACL reconstruction.
Catalog Number: 909668 Lot Number Identification: 716710
Thru hole at the tip of the screw is undersized.
Worldwide Distribution - USA (nationwide) and internationally to Australia, Belgium, Canada, South Korea, Taiwan, Hong Kong, Japan, Mexico, and Singapore.
BBL(TM) Fildes Enrichment, catalog number 211866, 10 tubes/pack, labeled in part ***Becton Dickinson and Company, Sparks, MD 21152 USA***   Intended Use: Fildes Enrichment may be used to enrich a variety of media for the cultivation of various microorganisms. Fildes Enrichment is a peptic digest of sheep blood used to enhance the growth of fastidious organisms. It may be added to Tryptic/Trypticase Soy Broth or Agar in final concentration of 5% for cultivation of Haemophilus influenzae. Fildes Enrichment is intended to be a rich source of growth factors stimulatory to various microorganisms, including the X (hemin) and V (nicotinamide adenine dinucleotide, NAD) factors necessary for the growth of Haemophilus influenzae. Labeling: For Laboratory Use.
Enrichment media intended to enhance the cultivation  of various microorganisms may fail to support the growth of Haemophilus species.
Food Club Chocolate Chunk Brownie Mix, packaged in 21.5-oz. boxes, UPC# 36800-13486, distributed by TOPCO Associates LLC, Skokie, IL.
The product contains walnuts and it was packaged in the wrong carton.  Due to the mis-packaging the ingredient label does not have walnuts listed.
Worldwide Distribution-USA (nationwide) and the countries of  Canada, India, Japan, Nepal, Malaysia, Singapore, Brazil, Costa Rica, and Virgin Islands.
BD Vacutainer Buffered Sodium Citrate (9NC) Plus Blood Collection Tubes; Sterile; IVD; REF 363083; 13 X 75 mm, 2.7 mL
Lot No. 2180434; Expiration Date: April 2013
BD is conducting a recall of the BD Vacutainer 2.7mL Plus Citrate Blood Collection Tube due to extended Partial Thromboplastin Time (aPTT) test results reported in two customer complaints.
Nationwide, AR, CA, CO, FL, GA, IO, MI, MO, NC, ND, NE, NJ, SC, TN, TX, UT, WI
Growth Factor Complex 200 GFC 200, Dietary Supplement 2 Fl Oz, Manufactured for: Soto Supplements P.O. Box 75774 Colorado Springs, CO 80237, Instructions: Place drops under your tongue for 2 min then swallow.  Do not eat or drink for 15 min. Only approved for distribution from Authorized Distributors/Retailers, pharmaceutical laboratories and governmental research facilities.
Eon Nutra, LLC is recalling certain SOTO Supplements GFC 200 because the liquid dietary supplement products may be contaminated with various types of bacteria.
Femtrace 0.9 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Femtrace 0.45 mg (Estradiol Acetate) Tablets, Rx Only, 100 tablets, Manufactured by Pharmaceutics International Inc, Hunt Valley, MD 21031 for Warner Chilcott Company LLC, Fajardo, PR 00738
HILLYARD, Alcohol Free Foaming Instant Hand Sanitizer, Benzalkonium Chloride 0.10%, 1.25 L plastic bottle, OTC, HILLYARD IDUSTRIES, St. Joseph, MO. 64502 NDC 76402-403-03
Microbial Contamination of Non-Sterile Products: The product may be contaminated with bacteria.
Distribution was made to MI, KY, WI, OH,
Kitchen Essentials Imitation Bacon Flavored Bits, contains soy and wheat, packaged in 10 lb bulk cartons. Distributed by Gordon Food Service, Grand Rapids, MI. UPC 0 00 93901 6, Supplier item 293628
The product contains Soy and Wheat and is packaged in cartons in which the ingredient statement is missing.
Worldwide Distribution.USA including the states of AR, AZ, CA, CO, DE, FL, GA, IL, IN, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WI, and WV, and the countries of China, Curacao and Japan.
BacT/ALERT SA Blood Culture Bottle.   The BacT/ALERT SA reagent bottle is intended to be recover and detect aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
Catalog Number: 259789, Lots/Batch: 1031866
BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors.
Worldwide Distribution - USA including the states of  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, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, & WV. and the countries Arab Emirates, Australia, Belgium, Canada, Chile, China, Colombia, Cyprus, Hong Kong, Indonesia, Israel, India, South Korea, Kuwait, Malaysia, Panama, Philippines, Puerto Rico, Russia, Saudi Arabia, Singapore, Slovenia, Thailand, Turkey & Vietnam.
Ethicon Endo-Surgery Inc. The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures.    Model Numbers:   NSLG2C14           NSLG2C25            NSLG2C35  NSLG2C45  NSLG2514  NSLG2S25  NSLG2S35  NSLGS545
Product Code NSLG2C14, Lot # H44Y2P, Exp. Date 11-2013, Lot # J4AR58, Exp. Date 4-2017, Lot # J4AT3V, Exp. Date 4-2017, Lot # J4AW5A, Exp. Date 5-2017, Lot # J4AX7D, Exp. Date 5-2017, Lot # J4C34A, Exp. Date 6-2017, Lot # J4C448, Exp. Date 7-2017, Lot # J4C449, Exp. Date 7-2017, Lot # J4C85G, Exp. Date 7-2017, Lot # J4CF5Z, Exp. Date 9-2017 and Lot # J4CG31, Exp. Date 9-2017.   Product Code NSLG2C25, Lot # H44Z6V, Exp. Date 11-2013, Lot # J4A16C, Exp. Date 12-2013, Lot # J4AT1P, Exp. Date 4-2017, Lot # J4AR5L, Exp. Date 4-2017, Lot # J4AU2K, Exp. Date 5-2017, Lot # J4AV17, Exp. Date 5-2017, Lot # J4AW75, Exp. Date 5-2017, Lot # J4AW76, Exp. Date 5-2017, Lot # J4AY0T, Exp. Date 5-2017, Lot # J4C09P, Exp. Date 6-2017, Lot # J4C30A, Exp. Date 6-2017, Lot # J4C34L, Exp. Date 6-2017, Lot # J4C44N, Exp. Date 7-2017, Lot # J4C928, Exp. Date 7-2017, Lot # J4C92C, Exp. Date 7-2017, Lot # J4C968, Exp. Date 8-2017, Lot # J4CA4P, Exp. Date 8-2017, Lot # J4CF0D, Exp. Date 8-2017, Lot # J4CH3W, Exp. Date 9-2017, Lot # J4CJ5Y, Exp. Date 9-2017, Lot # J4CJ99, Exp. Date 9-2017 and Lot # J4CK1H, Exp. Date 9-2017.    Product Code NSLG2C35, Lot # H44V7N, Exp. Date 10-2013, Lot # H44V7M, Exp. Date 10-2013, Lot # H44V7P, Exp. Date 10-2013, Lot # H44X9M, Exp. Date 11-2013, Lot # H44X9L, Exp. Date 11-2013, Lot # H44X9R, Exp. Date 11-2013, Lot # H44Z3R, Exp. Date 11-2013, Lot # H44Z4C, Exp. Date 11-2013, Lot # H44Z54, Exp. Date 11-2013, Lot # J4A085, Exp. Date 12-2013, Lot # J4A134, Exp. Date 12-2013, Lot # J4AN7K, Exp. Date 4-2017, Lot # J4AN8E, Exp. Date 4-2017, Lot # J4AN8D, Exp. Date 4-2017, Lot # J4AP7W, Exp. Date 4-2017, Lot # J4AR5P, Exp. Date 4-2017, Lot # J4AT05, Exp. Date 4-2017, Lot # J4AT9G, Exp. Date 4-2017, Lot # J4AT9V, Exp. Date 4-2017, Lot # J4AU2Z, Exp. Date 5-2017, Lot # J4AV2R, Exp. Date 5-2017, Lot # J4AV2V, Exp. Date 5-2017, Lot # J4AV4P, Exp. Date 5-2017, Lot # J4AV4Z, Exp. Date 5-2017, Lot # J4AW3F, Exp. Date 5-2017, Lot # J4AW3N, Exp. Date 5-2017, Lot # J4AW8P, Exp. Date 5-2017, Lot # J4AW8Y, Exp. Date 5-2017,
Ethicon Endo-Surgery initiated a voluntary global recall for all production lots of ENSEAL G2 Curved and Straight Tissue Sealers due to a potential for self activation while the device is in use, which may result in unintended thermal damage.
Kinnikinnick Foods Pie Crusts, 10.2 oz, Item  code: 21-35265, UPC 6-20133-00600.
Unified Grocers is recalling Kinnikinnick Pie Crust because it contains undeclared egg allergen.
Kinnikinnick Pie Crust (frozen) Weight: 290 g/10 oz Qty/Pkg: 2 UPC: 62013300600 9
Kinnikinnick Foods, Inc in Edmonton, Alberta Canada indicated that KeHE Distributors in Bloomington, IN had received pie crusts in association with their recall/allergy alert issued 12/28-29/2012
Nationwide including Arizona, California, Colorado, Connecicut, Florida, Georgia, Idaho, Illinois, Kentucky, Louisiana, Michigan, Missouri, Montana, New England, New Jersey, New Mexico, Nevada, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virgina and Wisconsin.
Spice Cake Mix , 25 lb. and 50 lb. kraft bags, labelled a) CMC Quality and Value, Spice Cake Mix, 46702-00985, NET Wt. 25 lbs. (11.34 kg) JIFFY Foodservice, LLC, Chelsea, Michigan 48188; b) CMC Quality and Value, Spice Cake Mix, 46702-00920, NET Wt. 50 lbs. (22.68 kg.), JIFFY Foodservice, LLC, Chelsea, Michigan 48188.
7,422 bags (total 25 lb. and 50 lb. combined)
Undeclared Allergen (Milk).  Firm initiated a voluntary recall of their 25 lb. and 50 lb. bags of Spice Cake Mix that had been distributed since August 2012 due to an undeclared allergen, milk. The Spice Cake Mix is manufactured for correctional facilities/institutions only.
Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010.   The Dimension(R) IRON Calibrator is an in vitro diagnostic product intended to be used to calibrate the Iron method for the Dimension(R) clinical chemistry system.
Siemens Healthcare Diagnostics has received complaints of IRON calibrations outside of acceptable calibration slope (m) values (0.97 - 1.03) when using IRON calibrator lots 2DN060 and 2FN063.  Lots 2GN068 and 2JN074 may also be impacted but no complaints have been received.
***GFS***CLAW MEAT***Wild-Caught and Hand-Picked***PASTEURIZED CRAB***Carne de mano de jaiba*** NET WT/PESO NETO***16 OZ (1 LB) 453g***Reorder #536030***PRODUCT OF THAILAND***.
Concern with Time/Temperature abused during transit.
Product was shipped to the following states: AZ, CA, FL, MA, MN, MS, NC, NY, OH, SC, TX, VA, WA & WY.
Island Delights Coconut Haystack Candy Maple  Natural Flavor Coconut Haystacks, NET WEIGHT 2 OZ, 4 oz and 8 oz clear plastic bags. Bags labeled in part ''INGREDIENTS: SUGAR, COCONUT***NATURAL MAPLE FLAVOR***Island Delights, Inc. Seville, OH 44273''
45/2 oz bags, 207/4 oz bags, 50/8 oz bags & 13/2 lb bags = 315 BAGS
During a visual inspection from Ohio Dept of Agriculture the firm was notified that they did not list milk in their ingredient statement.
Island Delights Almond Chocolate/Almond Mix Natural Flavor Coconut Haystacks, NET WEIGHT 2 oz, 4 oz, 8 oz and 2 lb clear plastic bags. Bags labeled in part ''INGREDIENTS: SUGAR, COCONUT***COCOA***NATURAL ALMOND FLAVOR***Island Delights, Inc., Seville, OH 44273''
12/2 oz bags, 26/4 oz bags, 13/8 oz bags & 2/2 lb bags
Island Delights COFFEE NATURAL Natural Flavor Coconut Haystacks, NET WEIGHT 2 oz, 4 oz, 8 oz and 2 lb clear plastic bags. Bags labeled in part ''INGREDIENTS: SUGAR, COCONUT***COCOA***NATURAL COFFEE FLAVOR***Island Delights, Inc. Seville, OH 44273''
Island Delights ALMOND Natural Flavor Coconut Haystacks, NET WEIGHT 2 oz, 4 oz, 8 oz and 2 lb clear plastic bags. Bags labeled in part ''INGREDIENTS: SUGAR, COCONUT***COCOA***NATURAL COFFEE FLAVOR***Island Delights, Inc., Seville, OH 44273''
1/2 oz bag, 4/4oz bags, 5/8 oz bags = 10 bags
Ocean Harbor  Smoked Salmon Spread Net Wt 5 lb.(2.27 kg). UPC: 0 32345-77707 1  Dist by Roundy's Inc.
Dawn's Foods, inc. is conducting a voluntary recall of certain seafood products packaged in 5# and 10 oz. containers.  This is being done with the abundance of cation due to the fact that we cannot exclude the possibility that the affected sizes may be a viable environment for pathogen growth.
Ocean Harbor  Cajun Krab Spread  Net Wt 5 lb (2.27 kg)  UPC: 0 32345-77711 8  Dist by Roundy's Inc.
Ocean Harbor  Jalapeno Krab Spread  Net Wt 5 lbs (2.27kg) UPC: 0 32345-77715 6   Dist by Roundy's Inc.
Five Star Dip  Smoked Salmon Dip Net WT 10 oz (284g).  UPC: 0 32345 61463 5   Mfg By Dawn Food, Portage, WI 53901.   Dawns  Smoked Salmon Dip NET WT 5 LBS (2.27 kg)  UPC: 0 32345 61480 2   MFG BY DAWN'S FOODS, INC., PORTAGE, WI 53901
Five Star Dip  Cajun Krab Dip  Net Wt 10 oz (284g). UPC: 0 32345 84063 8, Mfg By Dawns Foods, Inc., Portage, WI 53901.     84080  Dawns Cajun Krab Dip  NET WT 5 LBS (2.27 kg),   UPC: 0 32345 88888 3   MFG BY  DAWN'S FOODS, INC., PORTAGE, WI 53901
Dawns Alaskan Krab and Shrimp Salad NET WT 5 LBS (2.27 kg),  UPC: 0 32345 70103 8   MFG BY DAWN'S FOODS, INC., PORTAGE, WI 53901   Ocean Harbor Krab and  Shrimp Salad NET WT 5 LBS (2.27 kg),   UPC: 0 32345 77701 9  Dist by Roundy's Inc.
Dawns Alaskan Krab Salad NET WT 5 LBS (2.27 kg), UPC: 0 32345 85072 9 , MFG BY DAWN'S FOODS, IN., PORTAGE, WI 53901   Ocean Harbor Alaskan Krab Salad NET WT 5 LBS (2.27 kg),  UPC: 0 32345 77705 7, Dist by Roundy's Inc.
US Nationwide Distribution including the country of Switzerland.
HAMILTON-T1 Ventilator with software versions  1.1.2 or lower.     The HAMILTON T-1 Ventilator is intended to provide positive pressure ventilatory support to adults and pediatrics
Software Versions 1.1.2 and below; Part numbers 161005, 161006.
97 total ventilators; 69 of part number 161005 and 28 of part number 161006
Analysis of a customer complaint has shown that during ventilation of small pediatric patients with high airway resistance and low lung compliance, the oxygen consumption of a Hamilton T1 ventilator with software versions 1.1.2 and lower must be calculated using a larger margin than originally expected.
Worldwide Distribution-USA including the states of CA, IN, KS, MA, NJ, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CANADA, DENMARK, FRANCE, GERMANY, ITALY, JAPAN, PORTUGAL, and SWITZERLAND.
45 Angle Driver / Z-H, Greatbatch Medical 10 000 Wahrie Drive, Clarance, NY 14031.   Model #:   P2661, P2662, T3635, T5586,T6031, T6164,T10161, T12628,T14879, T16422,T2487,T2713,T116057, T13635, MPU260045AO01, MPU260045ZH01.    The Driver is intended to act as an interface between the cutting tool and a motorized driving system (i.e. surgical drill).
Greatbatch Medical has initiated a global voluntary recall and market withdrawal of its entire Small Angled Driver 45 product line.  Greatbatch has received reports of noisy and / or rough operation when  using these Small Angled Drivers.
US Nationwide Distribution including the states of California, Florida, Texas, Illinois, Indiana, Maryland, Pennsylvania and Canada.
KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number  IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME:  Dental Intraoral Radiographic Film -- 20 cartons of 80 packets.   Product Usage:  Dental intraoral radiography
101 cartons: Domestic - 95 cartons; Foreign - 6 cartons
The company discovered that some cartons of KODAK INSIGHT with SureSoft Packets Dental Film Catalog Number  8118226 have missing symbols and manufacturing information on the clear carton label.  The expiration dating symbol is missing but the expiration date is not missing.  The Lot symbol is missing but the lot number is not missing.  The Manufacturer symbol, name and address including country of origin are missing.   All of the remaining symbols and information are on the case label.  Missing information is only associated with the clear carton label.
Knott's FINE FOODS, CHICKEN SALAD (sandwich), KNOTT's WHOLESALE FOODS, INC. 125 North Blakemore, Paris, TENNESSEE  38242, (731) 642-1961 www.knotsfoods.com, UPC 011984011326
all date codes up to and including 01/29
Sample collected by State of Tennessee Department of Agriculture was found to contain Listeria Monocytogenes
Product was shipped to the following state: Texas
DYMATIZE NUTRITION ELITE Gourmet Cookies & Cream 6-LAYER HI-PROTEIN BAR Label reads in part ''NET WT***INGREDIENTS: Elite Protein Blend***Distributed by: Dymatize Enterprises, Inc. 13737 N. Stemmons FWY, Dallas, TX 75234, (888) 334-LEAN or (972) 732-1990.
Dymatize Nutrition Elite Gourmet Cookies & Cream 1.5oz (42.5g), UPC Code, 705016993147, Lot # 12200A, Best By Date SEP 2013, Lot # 12249A, Best By Date NOV 2013, Lot # 12310A, Best By Date JAN 2014 & Lot # 12353A, Best By Date FEB 2014. Dymatize Nutrition Elite Gourmet Cookies & Cream 3oz (85g), UPC Code, 705016993000, Lot #, 12072A, Best By Date MAY 2013, Lot # 12200A, Best By Date SEP 2013, Lot # 12310A, Best By Date JAN 2014 & Lot # 12353A, Best By Date FEB 2014.
Belmont was notified by their customer, Dymatize, that a consumer complained on an allergic reaction after eating the product.  The consumer is allergic to peanuts & peanut protein.
DYMATIZE NUTRITION ELITE Gourmet Fudge Brownie 6-LAYER HI-PROTEIN BAR Label reads in part ''NET WT***INGREDIENTS: Elite Protein Blend***Distributed by: Dymatize Enterprises, Inc. 13737 N. Stemmons FWY, Dallas, TX 75234, (888) 334-LEAN or (972) 732-1990.
Dymatize Nutrition Elite Gourmet Fudge Brownie 1.5oz (42.5g), UPC Code, 705016993130, Lot #, 12199A, Best By Date SEP 2013, Lot # 12244A, Best By Date OCT 2013, Lot # 12311B, Best By Date JAN 2014 & Lot # 12352B, Best By Date FEB 2014. Dymatize Nutrition Elite Gourmet Fudge Brownie 3oz (85g), UPC Code, 705016993079, Lot #, 12084A, Best By Date MAY 2013, Lot # 12199A, Best By Date SEP 2013, Lot # 12205A, Best By Date SEP 2013, Lot # 12311B, Best By Date JAN 2014 & Lot # 12352B, Best By Date FEB 2014.
Carvedilol Tablets, USP, 12.5 mg, 500-count tablets per bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-3633-05, UPC 3 0378-3633-05 3.
Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.
Customers are retail locations in 6 states: Illinois, Indiana, Kentucky, Michigan, Missouri, and Ohio.
Kinnikinnick Pie Crust (frozen), Weight: 290 g/10 oz, Qty/Pkg: 2, Product packaged in a cardboard box with printed label. UPC: 62013300600 9
Kinnikinnick Foods, Inc. in Edmonton, Alberta Canada indicated that United Natural Foods Inc. distributors received pie crusts in association with their expanded recall/allergy alert issued 01/17/13.