Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
Blood product, which was labeled with an incorrect expiration date, was distributed.
Blood products, collected from a donor whose arm scrub procedure was performed incorrectly, were distributed.
Washington, Oregon, Utah, California, and Idaho.
Blood products, which were collected from  donors in which donor suitability was not adequately determined, were distributed.
Distributed to a medical center in Idaho.
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed.
Hoxworth Blood Center University of Cincinnati Medical Center
Blood product, collected from a donor who was taking the drug Prednisone, were distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed.
Blood products, held in transit storage container for 24 hours and possibly exposed to unacceptable temperatures, were distributed.
Blood product, manufactured without the entire quantity of additive solution, was distributed.
The recalling firm notified the Minnesota consignee by letter on 02/02/2006. The consignee responded that the unit was transfused.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood products, collected from donors who did not have a complete physical examination, were distributed.
Worldwide Distribution - USA including CO and NC; Internationally to Belgium.
ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc.  The ILLICO MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
The rods were incorrectly laser etched as ILLICO Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length.
Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
Plasma Frozen within 24 Hours After Phlebotomy (FP24)
The pizza dough shells come in 5 lb. brown cardboard boxes, containing 25 shells per box.
There is no labeling on the product, and the product contains the allergen, wheat.
Product was distributed in the United States, Algeria, Australia, Bulgaria, Canada, Cyprus, Czech Republic, Dominican Republic, France, French Polynesia, Germany, Indonesia, Italy, Jordan, Korea, Mexico, Netherlands, Philipines, Portugal, Puerto Rico, Qatar, Russia, Slovenija, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and United Kingdom.
Dymatize Nutrition XPAND Post Xtreme Mass Recovery System Lemonade 3.5 lb Manufactured & Distributed by Dymatize Enterprises, LLC, 13737 N. Stemmons FWY. Dallas, TX 75234   UPC 705016895649
The product label declares whey but does not declare milk.
Dymatize Nutrition XPAND Post Xtreme Mass Recovery System Fruit Punch 3.5 lb Manufactured & Distributed by Dymatize Enterprises, LLC, 13737 N. Stemmons FWY. Dallas, TX 75234   UPC 705016895625.
Dymatize Nutrition XPAND Post Xtreme Mass Recovery System Blue Raspberry 3.5 lb Manufactured & Distributed by Dymatize Enterprises, LLC, 13737 N. Stemmons FWY. Dallas, TX 75234   UPC 705016895601.
Grilled Chicken Marinade, IFF Code 3559317, Net Weight 50 Lb, Batch 0004700696, 004705802, and 004722458, Production Date 04/20/2012 and 05/01/2012, For Manufacturing Use Only.
Product has the potential to be contaminated with Salmonella.
Natural Chicken Flavor Seasoning, IFF Code: 3714201, Net Weight 50 lbs, Batch 0004706362, Production Date 04/25/2012, For Manufacturing Use Only.
Nat Flavor Beef Marrow, IFF Code: ULL681883, Net Weight 50 lb, Batch 0004684926, Production Date 04/25/2012, For Manufacturing Use Only.
IFF Code: ULL681883, Batch 0004684926, and Production Date 04/25/2012.
Nat Flv Beef FF, IFF Code 13580894, Net Weight 50 lb, Batch 0004702577, Production Date 04/23/2012, For Manufacturing Use Only.
Beef, IFF code: SN418156, Net Weight 50 lb, Batch 0004714076, Production date 04/23/2012, For Manufacturing use only.
IFF code: SN418156, Batch 0004714076, and Production date 04/23/2012.
Nat Beef FF, Iff Code ULL89721, Net Weight 50 Lb, Batch 0004696310, Production Date 04/23/2012, For Manufacturing Use Only.
Iff Code ULL89721, Batch 0004696310 and Production Date 04/23/2012
Bean Sauce Seasoning, IFF Code: 76185, Net Weight 25 lb, Production date:04/26/2012, For Manufacturing use only.
Blood product, collected from a donor whose donor records failed answers to follow-up questions regarding vaccinations, was distributed
The Dannon Company, Inc - Discovery & Innovation Center
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
The product was distributed nationwide including the states of: FL, GA, IL, IN, KY, MD, ME, MI, NC, NY, OH, PA, SC, VA, WI.
Dannon Activia LIGHT Nonfat Yogurt Peach Flavor 4x4oz cups INGREDIENTS: CULTURED GRADE A NONFAT MILK, WATER, PEACHES ***DISTRIBUTED BY: THE DANNON COMPANY, INC. WHITE PLAINS, NY 10603 UPC 36632 02633 Expiration code of DEC 04 2012 MZ
UPC 36632 02633 Expiration code of DEC 04 2012 MZ
The recalled products may potentially contain metal fragment(s) from a faulty manufacturing part.
Dannon Activia LIGHT Nonfat Yogurt Strawberry / Blueberry Flavor 12-4oz cups STRAWBERRY INGREDIENTS: CULTURED GRADE A NON FAT MILK, STRAWBERRIES***BLUEBERRY INGREDIENTS: CULTURED GRADE A NON FAT MILK, BLUEBERRY PUREE***DISTRIBUTED BY THE DANNON COMPANY, WHITE PLAINS, NY 10603***UPC 36632 03581 Expiration code of DEC 05 2012 MZ
UPC 36632 03581 Expiration code of DEC 05 2012 MZ
Dannon Light & Fit Carb & Sugar Control Cultured Dairy Snack Vanilla Flavor 4x4oz cups
UPC 36632 00427 Expiration code of NOV 25 2012 MZ
Product was distributed within the United States to AL, AZ, CA, DC, FL, LA, MD, MI, MO, NJ, NM, NC, OH, OR, PA, TN, TX, UT, VA, and WA.
Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085.   Quality Control (QC) materials have not exhibited low recovery of the same magnitude.  Internal method regression testing versus LC/MS has shown an average 25% low bias compared to LC/MS across the assay range.  Individual patients, particularly samples with lower TACR values (e.g., less than 5 ng/mL [6.5 nmol/L]), may show a more appreciable difference due to the typical precision of each methodology.
Community Blood Centers of Florida, Inc.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Inova Health Care Services, Inova Blood Donor Services
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Aurora Area Blood Bank Dba Heartland Blood Centers
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, labeled leukoreduced but which did not meet the requirements for leukoreduced products, were distributed.
Blood product, incorrectly determined to be negative for the Fyb antigen, was distributed.
Blood product, collected from a donor whose hemoglobin was not recorded during donor screening, was distributed.
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
Blood products, collected from a donor who received a body piercing within 12 months of donating, were distributed.
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
Community Blood Centers of South Florida, Inc.
MTS A/B/D Monoclonal and Reverse Grouping Cards (Catalog # MTS080515) and MTS A/B Monoclonal Grouping Cards (Catalog # MTS080017)
In-vitro diagnostic test cards, associated with complaints of an incomplete foil seal for specific lots of ID-Micro Typing System Gel Cards, were distributed.
MTS Anti-IgG Cards (Catalog # MTS084024)
Blood products, collected from a donor whose suitability was not adequately determined, were distributed.
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, general appearance of the donor or hemoglobin screening, was distributed.
Blood products, which did not meet the acceptable product specifications, were distributed.
Hoxworth Blood Center  UC Medical Center
Blood product, collected from a donor whose health history was not adequately performed, was distributed.
Worldwide Distribution - USA Nationwide.
Specialist 2 IM Rod,  Non-Sterile and associated Surgical Techniques:Sigma HP Instruments Classic Surgical Technique,0612-89-510 Sigma HP Instruments Balanced Surgical Technique, 0612-88-510 Sigma HP Instruments Fixed Reference Surgical Technique, 0612-87-510 PFC Sigma Knee Systems Primary Cruciate-Retaining & Cruciate-Substituting Procedure Surgical Technique,SP2-007   Product Usage: The SP2 IM Rod is used in both primary and revision Sigma knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included in both the SP2 and HP instrument kits.
Product Code 96-6120Label code / Etch code C3JHN4   H0808 C3JHS4   H0908 C3JHF4   H1008 C4GA54    C4GCC4    C4GBT4    C52F74   H1108 C52GV4   H1208 C52GL4    C67N14    C98CS4   H0109 C98BF4    DE5P34   H0309 DE5RP4    DF4H44    DG9LK4   H0409 DG9L64    DJ5E34    DK3E34   H0509 DK3FE4    EB5FV4   H0210 D95AN4    EB5GH4   H0310 EC9JY4    EF4DJ4    EJ7AP4   H0410 ES2G64   H0510 EJ7A34    ES2HA4   H0610 ES2HY4   H0710 EX5L44    EX5MS4   H0810 E2SD44   H0910 FA4G94   H0211 FD8MP4   H0311 FH8JA4    FH8JX4   H0611 TBACC   TBACC TBACZ   TBACZ FJ4E74   TBAGG
Potential for the IM rod to break, leaving fragments in the patient. Surgical Techniques guidance has been updated until design changes can be made to reduce likelihood of potential failure.
Multiple U.S. States - CA, MI, DC, TN, OK, PA, LA, WI, WA, OH, WV
Blood Grouping Reagent, Anti-e (Monoclonal)
Blood Grouping Reagent Anti-e (Monoclonal) BioClone, with potential of false negative results, was distributed.
Worldwide Distribution-USA (nationwide) and the countries of Argentina, Armenia, Kazakhstan, Russia, Ukraine, Australia, Austria Belgium, Luxembourg , Brazil, Canada, China, Colombia, Cyprus, Jordan Lebanon, Saudi Arabia, UAE, Czech Republic, Finland ,France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Latvia, Malaysia Mexico, Netherlands, New Zealand, Norway, Sweden, Poland, Portugal Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Turkey, and UK.
DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KITCatalog Number:283905000.  Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck
DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KITCatalog Number: 283907000.  Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KITCatalog Number: 283910000.  Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
DePuy CONFIDENCE SPINAL CEMENT SYSTEM  KITCatalog Number: 283913000.  Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
Human Corneal tissues, recovered from donors and not tested using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed.
Carisoprodol Tablets, USP, 350 mg Rx Only, 100 tablets per bottle, Rx Only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724, NDC 0143-1176-01.
Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance.  This product is being recalled because this controlled product was not relabeled with the required ''C-IV'' imprint on the label for products distributed after the 06/11/12 deadline.
Nationally (U.S.); Canada, UK, Hong Kong, and Australia.
Pascalite Capsules 100 count white plastic bottle with a screw on top, Pascalite Inc, PO Box 104 Worland, WY 82401 307-347-3872, Dietary Supplement for adults and children over 12 years two capsules daily, each vegi cap (size 00) contains approx. 1/4 tsp pascalite powder.
Lot numbers imprinted or hand written include: 2010M; and  D10 through 12 with a noted OT,U,V, or W.  The code information is found on the bottom of the product.
Pascalite is recalling internally used pascalite powder products because they may contain violative levels of lead.
Pascalite Powder 8 oz, 16 oz, 5 lb, and 25 lb packaged in semitransparent flexible plastic containers with a stick on label.  Pascalite Clay Powder, Pascalite Inc, PO Box 104 Worland, WY 82401, 307-347-3872 with directions for use as a Poultice, skin cleanser and softener, deodorant an freshener, dentrifice and oral hygiene, and dietary supplement for adults and children over 6.
Pascalite tooth powder, contained in a semitransparent flexible 6 oz. bottle with a flip top for dispensing.
Included in part of a total of 2,655 units.
Worldwide Distribution - USA Nationwide and the countries of:  Canada, Brazil, Colombia, Mexico, Puerto Rico, Venezuela, Guam, Honduras, Peru, Ecuador, Costa Rica.
Creatinine, Part Numbers OSR6178, OSR6678  Product Usage:   System reagent for the quantitative determination of Creatinine in human serum and urine on Beckman Coulter AU analyzers.
The recall was initiated by Beckman Coulter because they are including additional information and instructions in the Creatinine (OSR6x78) IFU and Setting Sheet, relating to calibration stability and quality control frequency to assure product performance.
Distributed in the states of IN, OH, PA, and TX.
Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Corrective osteotomies after distal radius malunion.
It was discovered that one of the VA-LCP Dorsal Distal Radius Plates was incorrectly etched as Part Number 02.115.431 (110 degree) instead of the correct Part Number 02.115.231 (90 degree).
Whole Foods Market Pacific NW Distribution Center (PDC)
14 Whole Foods Market retail stores in OR and WA.
Cold-smoked salmon in plastic containers.  An example of the labeling follows, however, the ''SELL BY:'' and ''PACK DATE'' changes.  ''0297629 015885  SOCKEYE SALMON LOX TRIM WHOLE FOODS MARKET  SALMON, SALT, SUGAR AND NATURAL HARDWOOD SMOKE.  CONTAINS: FISH***SELL BY: 02.06.13***PACK DATE: 01.30.13***''  There is a light blue water mark behind the ingredient statement that reads: ''WHOLE FOODS MARKET''
Distributed to 14 Whole Foods Market stores in WA and OR.  Amounts pending.
The repacked cold-smoked salmon trim was processed on  the same day as a surveillance sample was processed, that was found positive for Listeria monocytogenes.
Cream cheese/cold smoked salmon (Gravlox) spread in plastic containers.  A sample of product label (SELL BY and PACK DATES may differ): ''0295307 014144  LOX & CREAM CHEESE WHOLE FOODS MARKET  CCOLD SMOKED SALMON (SALMON, SALT, SUGAR AND NATURAL HARDWOOD SMOKE).  CREAM CHEESE (PASTEURIZED MILK AND CREAM, CHEESE CULTURE, SALT.***SELL BY 02.06.13***PACK DATE: 01.30.13***''  There is a light blue water mark behind the ingredient statement that reads: ''WHOLE FOODS MARKET''
Distributed to14 Whole Foods Markets in WA and OR.  Amounts pending.
Cold-smoked salmon trim, used to manufacture this cream cheese spread, was processed the same day as a surveillance sample was processed, that was found positive for Listeria monocytogenes.
Whole bagels and half bagels w/ cream cheese/cold smoked salmon spread wrapped in plastic. An example of the whole bagel label (in part): ''0298437 003996  BAGEL FULL LOX CREAM CHEESE CAPERS  BAGEL (ORGANIC WHEAT FLOUR, ORGANIC WHITE WHOLE WHEAT FLOUR, ORGANIC SUGAR, ORGANIC WHEAT GLUTEN, ORGANIC WHOLE WHEAT FLOUR, ORGANIC OAT FLOUR, YEAST, SALT, ORGANIC OAT FIBER, ORGANIC HIGH***SELL BY: 02.02.13***PACK DATE: 01.30.13***Whole Foods Market Inc., Bellevue, WA 98005***''  There is a light blue water mark behind the ingredient statement that reads: ''WHOLE FOODS MARKET''  An example of the half bagel label (in part): ''0292811 001998  HALF BAGEL WITH LOX CAPERS AND CREAM CHEESE CAPERS  BAGEL (ORGANIC WHEAT FLOUR, ORGANIC WHITE WHOLE WHEAT FLOUR, ORGANIC SUGAR, ORGANIC WHEAT GLUTEN, ORGANIC WHOLE WHEAT FLOUR, ORGANIC OAT FLOUR, YEAST, SALT, ORGANIC OAT FIBER, ORGANIC HIGH OELIC SUNFLOWER OIL, ORGANIC RAISIN JUICE CONCENTRATE, ORGANIC BARLEY FLOUR, ORGANIC GUAR GUM, ORGANIC CULTURED WHEAT***SELL BY: 02.02.13***PACK DATE: 01.30.13***''  There is a light blue water mark behind the ingredient statement that reads: ''WHOLE FOODS MARKET''
Half Bagel: PLU 92811, UPC: ''0292811 001998  Whole Bagel: PLU: 98437, UPC 0298437 003996 All products sold before 1/29/13.
Distributed to14 Whole Foods Markets in WA and OR.  Amounts pending
Cold-smoked salmon trim, used to manufacture these bagels, processed the same day as a surveillance sample was processed that was found positive for Listeria monocytogenes.
Worldwide Distribution - USA including the states of ME, MA, PA, MD, FL, LA, IL, IA, OH, MN, TX, MT, WA, CA, HI, NV, AZ, KY, WI, CO, GA, MI, TN, NY, AR, NC and VA and the countries of  Canada, Chile, Germany, Czech Republic, Israel , Norway, Poland, Slovenia, Australia, New Zealand, South Africa, Belgium, Austria, Switzerland, France, England and County Cork, Ireland.
ReClaim Reamer Extension; Product code 2975-00-500, used with Reclaim Modular Revision Hip Prosthesis System. The ReClaim Reamer Extension is as an attachment to the distal reamers to allow the surgeon to clear soft tissue while reaming the distal femoral canal.
DePuy has received 9 complaints where the tabs on the reamer extension device were broken. It was determined to notify surgeons of the issue to increase the awareness and to ask surgeons and users to look for tabs before and after surgery to reduce any potential that the tabs are left in the patient while DePuy investigates the root cause.  Once the root cause is determined and a design change is implemented, DePuy will conduct a formal swap-out of the affected devices.
Meprobamate, Tablets USP, 200 mg, 100 tablets; Rx only;  Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 9591-5239-01
Failed Impurities/Degradation Specifications: Watson Laboratories Inc. is recalling meprobamate  because an out of specification result for an impurity diphenyl sulfone .
Meprobamate; Tablets USP, 400 mg, 100 tablets; Rx only;  Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA; 173266; . Distributed by: Watson Pharma, Inc., NDC 0591-5238-01
Worldwide Distribution-USA including the states of Florida, Pennsylvania, New Hampshire, Oklahoma, California, Maryland, Arizona, Ohio, North Carolina, Texas, Virginia, Illinois, New York and Tennessee, and the countries of Australia, Belgium, Israel, Netherlands and United Kingdom.
Extremity Medical - Disposable Orthopedic Surgical Instrument - 1.6 mm Guidewire - Reference Number 101-00006 - Non-Sterile.  Contained in Extremity Medical Surgical Kits including CompressX, Hallu.X, IO Fix and XMCP.  Used in the selection of screw size when used with appropriate depth gauge.
Catalog Number 101-00006; Lot Number 00921538.
The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge reading will be about 2 mm longer than intended.
ZARAH Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tablets each, Manuf. by: Watson Laboratories, Inc., Corona, CA 92880. USA; Distributed by: Watson Pharma, Inc., Corona, CA 92880 USA. NDC 52544-981-31 Carton;  NDC 52544-981-28
Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
Worldwide Distribution - USA including the states of AZ, CA, GA, MN, NJ, and NM.  Internationally to Japan.
20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
Product Code:  V20LC; Lot/Serial Numbers:  BB09213 & BB09205
The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed up device engraving of V20LC (lot # BB09213) with that from V60C (lot # BB09205).
Brownberry Healthfull 45 Calories Per Slice Multigrain Bread, 1 LB 2 OZ (510g)
Best by dates prior to and including Feb 20
Firm has initiated a voluntary recall due to the possible presence of flexible wire caused by a faulty screen at a third party flour mill that supplied flour used in the manufacture of the recalled products.
Arnold Dutch Country 100% Whole Grain Bread, 1 LB 8 OZ (680g)
Brownberry Dutch Country 100% Whole Grain Bread, 1 LB 8 OZ (680g)
Arnold Healthfull 45 Calories Per Slice Multigrain Bread, 1 LB 2 OZ (510g)
Stroehmann Dutch Country 100% Whole Grain Bread, 1 LB 8 OZ (680g)
Aldi L'Oven Fresh Hearty 12 Grain Bread, NET WT 24 OZ (1 LB 8 OZ) 680g
Brownberry Healthfull Nutty Grain Bread, 1 LB 8 OZ (680g)
Brownberry Grains & More Double Protein Bread, 1 LB 8 OZ (680g)
Sara Lee 12 Grain Bread Hearty & Delicious, 24 OZ (1LB 8OZ) 680g
Best by dates prior to and including Feb 17
Earthgrains 12 Grain Natural Bread, NET WT 1 LB 8 OZ (680g)
Farm Bread All Natural Multi-Grain, NET WT 24 OZ (1 LB 8 OZ) 680g
Harmons 100% Multi-Grain Wide Pan Oven-Baked Bread, NET WT 24 OZ (1LB 8 OZ) 680g
Sara Lee Multi-Grain Thin Style Buns, NET WT 12 OZ (340g)
MET-Rx EXTREME NOS PUMPED WATERMELON Naturally and Artificially Flavored DIETARY SUPPLEMENT, 20 FL. OZ. (1.25 PT) (591 mL), UPC 7 49826 27603 8, Label Revision 02C, Item Number 27603 (Bottle) Item Number 27604 (case) --- Manufactured in the USA by MET-Rx Nutrition, Inc. Boca Raton, FL 33487
The color, odor, and taste of the products are changing and do not meet the firm's high quality standards.  This is an issue of commercial spoilage.
MET-Rx EXTREME NOS PUMPED DOUBLE BERRY Naturally and Artificially Flavored DIETARY SUPPLEMENT, 20 FL. OZ. (1.25 PT) (591 mL), UPC 7 49826 35909 0, Label Revision 01C, Item Number 35909 (Bottle) Item Number 35910 (case) --- Manufactured in the USA by MET-Rx Nutrition, Inc. Boca Raton, FL 33487
MET-Rx EXTREME NOS PUMPED NITRO-PUNCH Naturally Flavored DIETARY SUPPLEMENT, 20 FL. OZ. (1.25 PT) (591 mL), UPC Code 7 49826 00512 6, Label Revision 05D, Item Number 48515 --- Manufactured in the USA by MET-Rx Nutrition, Inc. Boca Raton, FL 33487
Distribution was made to AR, AL, AZ, CA, FL, GA, IL, IN, KY, LA, MS, ME, NV, NY, MO, OH, OK, PA, TX, UT, VA, WA, WI, WY and Canada.
Great Value All Natural Mild Chunky Salsa, 24 oz (1-lb 8-oz) 680 g.; UPC 007874208639; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR
The products may contain plastic pieces.
Great Value Salsa Mild, 16 oz (1lb) 454 g.; UPC 007874212780; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR
Great Value All Natural Medium Chunky Salsa, 24 oz (1lb 8oz) 680 g.; UPC 007874208640; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR
Great Value All Natural Hot Chunky Salsa, 24 oz (1lb 8oz) 680 g.; UPC 0078745208641; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR
Nationwide Distribution including MN, FL, PA, WI, NY, and RI.
INTIO Inc., ClearStart-SVM Segmentation and Volumetric Measurement System, Users Manual.  Part #: UM-06-20-0003.  ClearStart-SVM is used for patient assessment using CT (computed tomography) images, in order to plan potential therapies or monitor tumor response to treatment.
INTIO Inc. Part #: UM-06-20-0003 for SVM User's Manual
INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use.
Nationwide Distribution including the states of AL, IN, MO, NE TN and TX.
Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.
Increased risk of failure at the driver tip during screw insertion or removal.
Howmedica Osteonics Corp. Stryker Orthopaedics  Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401.  For use in knee prosthesis implantation.  NON-STERILE
Catalog Number:  I-K2401KF00 (note each is uniquely identified/marked as IK2401KF0L and IK2401KF0R - Left and Right).  Lot Codes:  AP5W52 and AP7H19.
The standard Triathlon Femoral Stylus does not fit into the Specialty Sizers and that the ''R'' and ''L'' markings on the Right Sizer are reversed.
Nationwide Distribution including the states of FL, AL, LA, PA, VA, IL, OH, NY, NC, KS, TN, NJ, CO, GA, CA, MD, MN, IN, & Puerto Rico.
Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
A dimensional mismatch was identified which can potentially allow for interference between devices.
Distributed to one customer in Michigan.
Sterile Access & Return Line Set, 36'' Length, Part # UM-872-36.   Intended for use with medically prescribed hemodialysis blood tubing.
The recalled product leaks at the connection site.
METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag,  Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24)
Lack of Assurance of Sterility: There is the potential for the solution to leak from the administrative port to the fill tube seal.
Product distribution was limited to Canada.
NuGo Free Trail Mix Bars, UPC 6 91535 45301 2
NuGo became aware of the possible inadvertent presence of milk in the NuGo Free Trail Mix Bar.
Nationwide, Costa Rica, Trinidad, and Bermuda
Heartland, AMERICA'S ORIGINAL, Harvest Spice Granola Cereal, NET WT 14 OZ. (397g), UPC 024300090394
Blue Planet products that contain the two recalled Dakota Specialty Milling ingredients; distribution of recalled bulk, wholesale, and cereal items.
Heartland, AMERICA'S ORIGINAL, Fruit & Nut Harvest Granola Cereal, NET WT 14 OZ. (397g), UPC 024300090387
Trio shipper which includes two of the recalled products:  Heartland, AMERICA'S ORIGINAL, Harvest Spice Granola Cereal, NET WT 14 OZ. (397g), UPC 024300090394 and Heartland, AMERICA'S ORIGINAL, Fruit & Nut Harvest Granola Cereal, NET WT 14 OZ. (397g), UPC 024300090387
Hannaford Autumn Spice Granola, UPC 041268186327, NET WT. 14 OZ (397g)
#38605020 ORTH TRANSMART(TM) PRE-BAKED CRISP TOPPING, NET WEIGHT 30 LBS. (13.6 kg)
10310 CRANBERRY ALMOND GRANOLA, 4/48 OZ.
Blue Planet, 10311 9 Grain Granola, NET WEIGHT 900 lbs (bulk product)
AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MI, MN, MS, NV, NY, OH, OK, OR, PA, TX, VA, WA, and WI
Sogeval Oxiderm +PS Shampoo (Benzoyl Peroxide 3%, Sulfur 2%, Salicylic Acid 2%, PhytoSphingosine 0.05%)  Antiseborrheic and Antiseptic Shampoo in a Moisturizing and Soap-Free Cleaning Base 16oz. - For topical use in dogs, cats and horses.
Product contains approximately 12 ounces instead of 16 ounces.
Worldwide Distribution- USA including the states of TX, NV, KY, GA, OH, PA, NY, AL, WA, IL and the countries of New Zealand and Japan.
Allen Traction Boot - Modular, OT 1000 Traction Device Boot Assembly, Fracture Table Orthopedic Leg Holders, non-invasive medical devices designed to attach to orthopedic fracture tables to aid clinical staff in applying traction to the leg of a patient during surgical procedures.
Some units may have been assembled incorrectly which could result in the boot breaking free from the mounting base and allowing the patient's leg to fall.
Worldwide Distribution -- USA, including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, IL IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT , VT, VA, WA, WV, and WI, and countries of GREECE, DENMARK, AUSTRIA, UNITED KINGDOM, SWITZERLAND, IRELAND, INDIA, TURKEY, POLAND, HUNGARY, ITALY, EGYPT, KOREA, PORTUGAL HONG KONG, GERMANY, SPAIN, MEXICO, SWEDEN, NORWAY SLOVENIA, NETHERLANDS, and BELGIUM.
Guardian II and Guardian II NC Hemostasis Valve,  Model #'s: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274.  Vascular Solutions Zerusa Limited 209 Business Innovation Centre, NUI Galway, Newcastle Road, Galway, Ireland.  Intended to maintain hemostasis during the use of diagnostic/interventional devices during diagnostic/interventional procedures.
Vascular Solutions, Inc., is recalling certain lots of Guardian II and Guardian II NC  Hemostasis Valves, due to the risk that air may be introduced into the device which may lead to an air embolism.
Vegi-Fiber Plus; O Trans Fat; only 15.4 Calories; Dietary Supplement; 60 Packets; Scientific formula for Natural Vitality; 15 Vegetable and Fruit Extracts; Newest Japanese Carbohydrate Blocker: Fibersol -2; Each Packet Contains 3.5g of Water-Soluble Dietary Fiber. Manufactured for Wynlife Healthcare, Inc., San Diego, CA 92130.
Wynlife healthcare is recalling their All-In-One Probiotics and Vegi-Fiber Plus products due to DEHP contaminated clouding agents.
All-In-One Probiotics, K12-BB12-LB3; Dietary Supplement; 30 Packets;Serving size 2 Tablets (1 Packet)l L141/1. Adults take 2 to 4 tablets daily; Children: take 1 to 2 tablets daily (or as directed by your healthcare practitioner. Chew slowly or allow to dissolve in mouth. Manufactured for Wynlife Healthcare, Inc., San Diego, CA 92130.
USA Nationwide Distribution including the states of:  AL, CA, FL, IN, MN, NE, NV, OH, SC and UT.
CR MD1.0 General Set, x-ray imager image plate. Product Usage:  Usage: The product is an image plate, contained in an X-Ray cassette, and used to capture images from X-Ray exposures. The cassette with the image plate, once exposed is inserted int he Agfa Digitizer CR 10-X where the image plate is taken out of the cassette and then scanned so that the scanned image can be displayed for viewing.
The cassettes were shipped with the wrong IP (image plate) size bar code.
Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-oz. tube, OTC. The firm name on the label is Novartis Consumer Health, Inc., Parsippany, NJ 07054.
Labeling: Incorrect or Missing Lot and/or Exp Date. The lot number and/or expiration date may be illegible.
Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC 0067-5812-96), b) 2-oz. tubes (NDC 0067-5812-86), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.
4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2086-05), b) 1-fl. oz. bottles (NDC 0067-2086-01), c) 1.25-fl. oz. bottles (NDC 0067-2086-15), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.
4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2087-05) b) 1-fl. oz. bottles (NDC 0067-2087-01), OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.
44,604/ .5-fl. oz. bottles and 439,452 /1-fl. oz. bottles
4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.
Worldwide Distribution - USA Nationwide including the states of New Mexico, North Carolina and the countries of Argentina, China, Mexico, and Taiwan.
Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation instaled with the CAS I/II Absorber.  Product Usage:   intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient-breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. This device is intended for use only by a suitably qualified physician.
108 total (17 units in the US and 91 units outside the US)
A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient.
Worldwide Distribution, USA including the states of AZ, CA, CO, DC, GA, IL, MD, MA, MN, NJ, NY, NC, OH, PA, SC, VA, WA and the countries of AUSTRIA, BELGIUM, CANDA, CZECH REPUBLIC, DENMARK, FRANCE, GERMANY, IRELAND, ITALY, NETHERLANDS, NEW ZEALAND, PORTUGAL, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, and the UNITED KINGDOM.
Boston Scientific/Cameron SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
Boston Scientific is conducting a recall on Cameron Health /Boston Scientific subcutaneous defibrillators (S-ICD System). BS identified a rare condition in which an internal protective fuse can be unintentionally activated while the device is charging its capacitors for shock delivery or induction. Should this occur, the defibrillator would not be able to deliver therapy or communicate with the Q-TECH Model 2020 programmer, and would be unable to emit tones or otherwise respond to magnet application.  No patient deaths or injuries have been reported as a result of this behavior; affected devices were replaced without the need for emergency medical care.
Rye bread with the following brands: Village Hearth , Rye Cottage Bread, NET WT 24 OZ ( 1 LB 8OZ) (680g) , East Coast Caraway Rye, NET WT 20 OZ (1 LB 4 OZ (567g) , PAN-O-GOLD VILLAGE HEARTH BAKER ST, ST. CLOUD, MN 56302.     Cub Foods, Deli Rye, NET WT 16 OZ (1 LB) 454 g, Distributed by SUPERVALU INC., Eden prairie, MN 55344.     Essential Everyday, Deli Rye Bread, NET WT 16 OZ (1 LB) 454 g Distributed by Supervalu Inc., Eden Prairie, MN 55344,                        Flvorite, Deli Rye, NET WT 16 OZ (1 lb) 454 g, Distributed by SUPERVALU INC., Eden prairie, MN 55344.     Family Choice, Northern Rye Bread, NET WT 16OZ (1 LB) (454G), Seeded Bye Bread, NET WT 20 OZ (1 LB 4 OZ) (567g),  Unseeded Rye Bread, NET WT 20 OZ (1 LB 4 OZ) (567g), PAN-O-GOLD VILLAGE HEARTH BAKER ST, ST. CLOUD, MN 56302.     Piggly Wiggly, Rye, Seeded Caraway Rye, NET WT 20 OZ (1LB 4 OZ) 568g., distributed by Piggly Wiggly LLC, Keene, NH 03431.     Food  Club, Rye, NET WT 16 OZ (1 LB) 454g., Distributed by Topco Associates LLC, 7711 Gross Point Road, Skokie, ILL 60077.     Shurfresh, Rye, Seeded Rye, Unseeded Rye, NET WT 16 OZ (1LB) 454g & 20 OZ (1LB 4 OZ) 567g., Distributed by Topco Associates LLC, 7711 Gross Point Road, Skokie, ILL 60077.
A recall has been initiated by Pan-O-Gold Baking Co. after they were notified by Dakota Specialty Milling of a potential foreign material (stainless steel wire from disintegrated sifter screen) risk to the rye flour Pan O Gold uses as an ingredient in all of their rye breads.
Worldwide Distribution-USA including DC and the states of CA, FL, IN, MA, MN, NJ, NY, NH, PA, WI, and NY, and the countries of Republic of China, Germany, and France.
PrimaConnex Tapered Implant  TC, SD Internal Connection 3.5 x 10mmCatalog Number: l5613K.  Implants in support for fixed bridgework.
Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled