The Recall Desk

Archive

January 2013 recalls

322 recalls were announced in January 2013.

What the numbers show

Critical
24
Severe
82
High
140
Moderate
51
Low
25

Of the 322 recalls this month scored against our rubric, 7% are Critical, 25% are Severe.

Which agencies issued them

101–200 of 322

  • SevereFDA (Drugs)·D-125-2013·2013-01-23

    Perrigo Recalls Prednisone Tablets Due to Foreign Substance Contamination

    L. Perrigo Co. is recalling specific lots of 10mg Prednisone tablets contaminated with trace food-grade lubricant and stainless steel inclusions.

    Product
    Prednisone tablets, USP, 10mg, Rx Only, Units of Use, NDC: a) 45802-303-67, 48-count Cartons, b) 45802-303-21, 21-count Cartons, Manufactured by: West-Ward Pharmaceutical Corporation, Eastown, NJ 07724, Distributed by: Perrigo, Allegan, MI 49040.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V022000·2013-01-23

    Thomas Built Buses Recalls Saf-T-Liner EFX School Buses for Lighting Defect

    Daimler Trucks North America is recalling 2013-2014 Thomas Built Buses Saf-T-Liner EFX school buses because a circuit breaker may trip, causing a loss of power to headlights and other lights.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0667-2013·2013-01-23

    Terumo Recalls Sarns Flexible Arterial Cannulas Due to Connector Flash

    Terumo Cardiovascular Systems is recalling Sarns flexible arterial cannulas and high-flow aortic arch cannulas because the connectors contain flash that may detach during surgery.

    Product
    Sarns flexible arterial cannula, 7.3 mm (22 Fr) OD with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cann
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0910-2013·2013-01-23

    Cap Sur Mer Recalls Frozen Cooked Lobster Tail Meat Due to Listeria

    Cap Sur Mer, Inc. is recalling specific lots of frozen cooked lobster tail meat because laboratory analysis detected Listeria monocytogenes.

    Product
    Frozen Cooked Lobster Tail Meat. Nautifish. 2 lb plastic bags, 6 items/case. Keep Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0666-2013·2013-01-23

    Terumo Recalls Sarns Arterial Cannulas Due to Connector Flash

    Terumo is recalling Sarns flexible arterial cannulas and high-flow aortic arch cannulas because connector flash may detach during surgery.

    Product
    Sarns flexible arterial cannula, 6.7 mm (20Fr) OD with 3/8 in. connector, suture ring, 9.5 in (24 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Ca
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0880-2013·2013-01-23

    Unilever Recalls Knorr Pasta Sides for Potential Soy Contamination

    Unilever is recalling Knorr Pasta Sides Cheesy Bacon Macaroni because some pouches may contain soy due to a packaging error.

    Product
    Knorr Pasta Sides Cheesy Bacon Macaroni Net Wt. 3.8 oz, (107 g) Unilever Englewood Cliffs, NJ 07632 USA Made in Canada from domestic and imported ingredients Case SCC 10041000082488 UPC 4100008248
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0690-2013·2013-01-23

    Perkinelmer Recalls Defective Truncated V-Bottomed Microplates

    Perkinelmer is recalling specific lots of truncated V-bottomed microplates because the wells are defective. These products are used for preparing and examining human body specimens.

    Product
    Microplate, truncated V-bottomed lots included in the above listed products Product Number: 1380 5465. DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0877-2013·2013-01-23

    Grandma's Peanut Butter Cookies Recalled for Undeclared Milk and Egg

    Frito-Lay is recalling Grandma's Peanut Butter Sandwich Creme cookies because they contain undeclared milk and egg.

    Product
    Grandma's Peanut Butter Sandwich Creme Cookies, Net WT. 3.025 oz, Frito-Lay, Inc. Plano, TX 75024
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0685-2013·2013-01-23

    DePuy Spine EXPEDIUM Offset Torque Wrench Recalled for Wear

    DePuy Spine is recalling 140 EXPEDIUM Offset Torque Wrenches because a handle component wears prematurely, potentially causing inaccurate torque readings.

    Product
    DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offset Spinal Construct.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0695-2013·2013-01-23

    Stryker Recalls Hoffman LRF Wire Bolts Due to Breakage During Use

    Stryker Howmedica Osteonics is recalling 476 Hoffman LRF Wire Bolts because two complaints reported the wires broke during load-bearing application by patients.

    Product
    Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0694-2013·2013-01-23

    Spacelabs Smart Disclosure System Recalled for Incorrect Waveform Display

    Spacelabs Healthcare is recalling the Smart Disclosure System, Model 92810, because it may display or print incorrect patient waveforms for the indicated time.

    Product
    Spacelabs Smart Disclosure System, Model 92810, is an integrated component of the Intesys Clinical Suite (ICS) G2, Version 4.03. The Smart Disclosure product collects patient waveforms, alarms, vital signs, and 12-lead reports. A 24-hour waveform acquisition is standard, with
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Food)·F-0892-2013·2013-01-23

    Fresh Unlimited Recalls Pineapple Chunks for Possible Listeria Contamination

    Fresh Unlimited Inc is recalling specific bags of Pineapple Chunks due to possible contamination with Listeria monocytogenes. The product was distributed to 15 states.

    Product
    Pineapple Chunks 80/2 oz (4.536g) bag Item #71607, BEST USED BY: 11/21/12 TC: 1 217 2359
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-0674-2013·2013-01-23

    Philips Recalls Brilliance 64 and Ingenuity CT Scanners Due to Software Anomalies

    Philips Medical Systems is recalling nine CT scanning systems due to software anomalies that could pose a risk of injury to patients and personnel if the issues recur.

    Product
    Brilliance 64 and Ingenuity CT Computed Tomography X-Ray Scanning Systems: Brilliance 64 - Model #728231; and Ingenuity CT - Model # 728326, Distributed By: Philips Healthcare, Cleveland, OH. The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to pr
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0883-2013·2013-01-23

    Dollar Tree Recalls Cherry Candy Canes Due to Metal and Plastic Pieces

    Dollar Tree is recalling cherry candy canes that may contain embedded metal or plastic pieces. Consumers should stop using the product.

    Product
    Candy Canes, Cherry Flavor, 5 oz boxes, packed 12 candy canes/box, and labeled in part ***Distributed by Greenbriar International, Inc., Chesapeake, VA 23320, MADE IN CHINA***
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0669-2013·2013-01-23

    Terumo Recalls Sarns High-Flow Aortic Arch Cannulas Due to Connector Flash

    Terumo is recalling Sarns high-flow aortic arch cannulas because connector flash may detach during surgery.

    Product
    Sarns high-flow aortic arch cannula, 5.2 mm (16 Fr) OD with 3/8in connector, 7.5in (19 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0670-2013·2013-01-23

    Terumo Recalls Sarns High-Flow Aortic Arch Cannulas Due to Connector Flash

    Terumo is recalling Sarns High-Flow Aortic Arch Cannulas and Flexible Arterial Cannulae because connector flash may detach during surgery.

    Product
    Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannulae are i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0909-2013·2013-01-23

    Frozen Cooked Lobster Meat Recalled for Listeria monocytogenes

    Cap Sur Mer, Inc. is recalling Captain Homard Frozen Cooked Lobster Meat because laboratory analysis detected Listeria monocytogenes in the product or a previous product from the same date code.

    Product
    Captain Homard Frozen Cooked Lobster Meat. Broken Tail Meat, 6X2 lb, plastic bags, 6 individual items per case. Keep Frozen.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0881-2013·2013-01-23

    Joey's Fine Foods Recalls Lemon Cake for Undeclared Yellow #5

    Local Baking, Co, Inc. T/A Joey's Fine Foods is recalling Joey's Gourmet Lemon Cake because it contains undeclared FD&C Yellow #5.

    Product
    JOEY'S GOURMET LEMON CAKE; NET WT 3 oz. (85 g); UPC 026104613403; Joey's Fine Foods, Inc., Newark, NJ 07104; 973-482-1400
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0897-2013·2013-01-23

    Fresh Unlimited Recalls Waldorf Salad Kits for Listeria Risk

    Fresh Unlimited Inc is recalling Waldorf Salad Kits due to possible contamination with Listeria monocytogenes. The product was distributed to 15 states.

    Product
    Waldorf Salad Kit 5.19lb (2,345g) bag Item #74802 INGREDIENTS: APPLES***MAYONNAISE***CELERY, WALNUTS CONTAINS: SOYBEAN OIL, EGG, TREE NUTS (WALNUTS) BEST USED BY: 11/23/12 TC: 13171319 15:43
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0878-2013·2013-01-23

    Grandma's Peanut Butter Cookies Recalled for Undeclared Milk and Egg

    Frito-Lay is recalling Grandma's Peanut Butter Mini Sandwich Creme Cookies because they contain undeclared milk and egg.

    Product
    Grandma's Peanut Butter Mini Sandwich Creme Cookies, Net WT. 1.71 oz, Frito-Lay, Inc. Plano, TX 75024
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0888-2013·2013-01-23

    Fresh Unlimited Recalls Sliced Green Apples Due to Listeria Risk

    Fresh Unlimited Inc is recalling sliced green apples due to possible contamination with Listeria monocytogenes. The product was distributed to 15 states.

    Product
    Sliced Green Apples READY TO EAT 14 oz Innerlock Bag UPC 95829 20042 Use By: 12/3/12, Item #71736
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0887-2013·2013-01-23

    Fresh Unlimited Recalls Red Apple Slices for Listeria Risk

    Fresh Unlimited Inc is recalling specific packages of Red Apple Slices due to possible contamination with Listeria monocytogenes.

    Product
    Red Apple Slices 2.4 oz, Item #71746, 20 oz, Item # 71729 14 oz, Item # 71735. Item #71729 is sold under the brand name Sonic UPC 95829 20000. The other two packages are in clear plastic bags.
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0882-2013·2013-01-23

    Dollar Tree Recalls Peppermint Candy Canes Due to Metal and Plastic Pieces

    Dollar Tree Distribution is recalling peppermint candy canes that may contain embedded metal or plastic pieces. The recall covers 3.1 million boxes distributed nationwide and in Canada.

    Product
    Candy Canes, Peppermint Flavor, 5 oz boxes, packed 12 individually candy canes/box, and labeled in part ***Distributed by Greenbriar International, Inc., Chesapeake, VA 23320, MADE IN CHINA***
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0889-2013·2013-01-23

    Fresh Unlimited Recalls Celery Sticks for Possible Listeria Contamination

    Fresh Unlimited Inc is recalling celery sticks due to possible Listeria monocytogenes contamination. The product was distributed to 15 states.

    Product
    Celery Stick 2" 80/2 oz clear plastic bag, Item #70648 USED BY: 11/21/12
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0898-2013·2013-01-23

    Fresh Unlimited Recalls Shredded Broccoli Fruit Salad Due to Listeria Risk

    Fresh Unlimited Inc is recalling Shredded Broccoli Fruit Salad due to possible contamination with Listeria monocytogenes. The product was distributed to 15 states.

    Product
    SHREDDED BROCCOLI FRUIT SALAD 6.19# (2,807 g) Ingredients: Broccoli, Cauliflower, Apples, Pears, Cole Slaw Dressing***Cranberry***Raisins CONTAINS: Soybean, egg BEST USED BY: 11/23/12 TC: 13171319 15:59***
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0896-2013·2013-01-23

    Fresh Unlimited Holiday Fruit Delight Kit Recalled for Listeria Risk

    Fresh Unlimited Inc is recalling Holiday Fruit Delight Kits due to possible contamination with Listeria monocytogenes. The product was distributed to 15 states.

    Product
    Holiday Fruit Delight Kit 5.1875 lbs (2,353g) INGREDIENTS: APPLES***RED GRAPES, STRAWBERRY GLAZE***MARSHMELLOW***WALNUTS, ALLERGENS: WALNUTS (TREE NUTS) BEST USED BY 11/23/12 TC: 13171319 15:42
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-0668-2013·2013-01-23

    Terumo Sarns Arterial Cannulas Recalled for Connector Flash Defect

    Terumo is recalling Sarns flexible arterial and high-flow aortic arch cannulas because exterior flash on the connectors may detach during surgery.

    Product
    Sarns flexible arterial cannula, 8.0 mm (24 Fr) with 3/8in connector, suture ring, 9.5in (24 cm) long The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible Arterial Cannula
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0671-2013·2013-01-23

    Terumo Recalls Sarns Aortic Arch Cannulas Due to Connector Flash

    Terumo is recalling Sarns high-flow aortic arch and flexible arterial cannulas because connector flash may detach during surgery.

    Product
    Sarns high-flow aortic arch cannula, 6.5 mm (20 Fr) OD with 3/8in connector, 11in (28 cm) long, with X coating surface The Sarns" High Flow Aortic Arch Cannula and Sarns" Flexible
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0893-2013·2013-01-23

    Fresh Unlimited Recalls Diced Red Apples for Listeria Risk

    Fresh Unlimited Inc is recalling diced red apple bags due to possible Listeria monocytogenes contamination. The product was distributed to 15 states.

    Product
    Red Apples DICED 3/4" 5/1# (4,536G) bag Item #71707 Ingredients: Apples (Apples, Calcium Ascorbate), BEST USED BY: 11/25/12 TC: 1 317 2359 15:40 PRODUCT OF: USA
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0894-2013·2013-01-23

    Fresh Unlimited Recalls Green Pepper Strips for Listeria Risk

    Fresh Unlimited Inc is recalling Green Pepper Strips due to possible contamination with Listeria monocytogenes. The product was distributed to 15 states.

    Product
    Green Pepper Strips 3/8" 80/2oz (4,536g) bag Item #73032 BEST USED BY: 11/21/12 TC: 1 317 2359 15:45
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0895-2013·2013-01-23

    Fresh Unlimited Recalls Sliced Radish Bags Due to Listeria Risk

    Fresh Unlimited Inc is recalling specific bags of sliced radishes due to possible contamination with Listeria monocytogenes.

    Product
    Radish Sliced 80/2oz bag Item #74605 BEST USED BY: 11/21/12 TC: 1 317 2359 15:45
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-0687-2013·2013-01-23

    Perkinelmer Recalls NEOBASE MSMS Kits Due to Defective Microplate Wells

    Perkinelmer is recalling NEOBASE Non-Derivatized MSMS Kits because the microplate wells used in the assays are defective. This may affect the accuracy of newborn metabolic disorder screening.

    Product
    NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass spectrometry (MSMS) reagent kit is intended for the measurement and evaluation of amino acids, succinylacetone, free carnitine, and acylcarnitine concentrations from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0890-2013·2013-01-23

    Fresh Unlimited Recalls Carrot Coins for Possible Listeria Contamination

    Fresh Unlimited Inc is recalling specific bags of carrot coins due to possible contamination with Listeria monocytogenes. The product was distributed to 15 states.

    Product
    Carrot coin 1/4" 80/2oz bag Item #70263 BEST USED BY 11/21/12 TC: 1 317 2359 15:43
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0885-2013·2013-01-23

    Marketside Chunky Bleu Cheese Dressing Recalled for Undeclared Dairy Allergen

    Naturally Fresh Inc. is recalling Marketside Chunky Bleu Cheese Dressing due to an undeclared dairy allergen. Consumers with dairy allergies should not consume the product.

    Product
    Marketside, Chunky Bleu Cheese Dressing, Net Wt. 14 fl. oz (414)mL, Manufactured For Marketside, a division of Wal-Mart Stores, Inc., Bentonville, AR 72716.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0692-2013·2013-01-23

    Quanta System Laser Recall for Inaccurate Promotional Website Claims

    Quanta System is recalling 12 Eterna Giovinezza laser units because its website contained promotional materials with claims not applicable to U.S. distributed devices.

    Product
    Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagulation of dermatological vascular lesions; Photothermolysis of blood vessels (treatment of facial and leg veins); Treatment of benign pigmented lesions; Inflammatory acne
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0691-2013·2013-01-23

    Quanta System Q-Plus T Laser Recall for Promotional Material Labeling

    Quanta System is recalling 75 Q-Plus T laser units because promotional materials on their website did not specify that certain claims did not apply to U.S. distributed devices.

    Product
    Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesions and pigmented lesions; Hair and tattoo removal; The incision, excision, ablation, vaporization of soft tissue for general dermatology. Ruby 694nm: Cutting, vaporization and abla
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Food)·F-0884-2013·2013-01-23

    S & M International Recalls Preserved Duck Eggs for pH Standard Violation

    S & M International Inc is recalling 855 cases of Yangsheng Preserved Duck Eggs because they do not meet the required pH standard for preserved eggs.

    Product
    Yangsheng Eggs Preserved Duck Eggs Content 6 pcs Net Wt: approx 12.69 oz (360g) S& M (USA) Enterprise Corp Rm3 8/F., Yuexiu Bldg., 160-174 Lockhart Road, Wan Chai, HK Distributed by : S & M Int'l Inc 100 Pulaski ST., Bayonne
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0697-2013·2013-01-23

    IDS Recalls 25-Hydroxy Vitamin D EIA Due to QC Error

    IDS is recalling 25-Hydroxy Vitamin D EIA kits because a quality control report contained an incorrect calibrator value.

    Product
    25-Hydroxy Vitamin D EIA, Catalog #AC-57F1. Product Usage: The IDS 25-Hydroxy Vitamin D EIA kit is an enzymeimmunoassay intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum or plasma. Results are to be
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0675-2013·2013-01-23

    Philips CT System Software Recall for Coronary Artery Labeling Defect

    Philips is recalling 108 CT systems because a software defect prevents users from labeling coronary arteries in rendered images.

    Product
    Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by c
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Devices)·Z-0673-2013·2013-01-23

    Vycor Medical Recalls Brain Access System Due to Black Fiber

    Vycor Medical is recalling 3,000 ViewSite Brain Access System devices because an unidentified black fiber was found on the product.

    Product
    Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** Product Usage: The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0689-2013·2013-01-23

    Perkinelmer Recalls Defective DBS Microplates for Assay Use

    Perkinelmer is recalling 56 kits of DBS Microplates, Truncated V-Bottomed, due to defective wells that may affect assay results.

    Product
    DBS MICROPLATE, TRUNCATED V-BOTTOMED Product Number: 3033-0010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0688-2013·2013-01-23

    Perkinelmer Recalls Neonatal Total Galactose Kits Due to Defective Microplate Wells

    Perkinelmer is recalling Neonatal Total Galactose Kits because the microplate wells used in the assays are defective, which may affect the accuracy of newborn screening results.

    Product
    NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010, 3029-001B. This kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-129-2013·2013-01-23

    James G. Cole Recalls I-C Drops Eye Cleansing Agent for Sterility Labeling

    James G. Cole, Inc. is recalling I-C Drops Eye Cleansing Agent because the label does not state the product is sterile, as required by FDA regulations.

    Product
    I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0686-2013·2013-01-23

    Perkinelmer Recalls Defective NEOGRAM Tandem Mass Spectrometry Kits

    Perkinelmer is recalling 180 NEOGRAM Amino Acids and Acylcarnitines Tandem Mass Spectrometry Kits because they contain defective microplate wells.

    Product
    NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. This kit is intended for the measurement and evaluation of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0693-2013·2013-01-23

    Quanta System Laser Surgical Instrument Recall for Promotional Material Claims

    Quanta System is recalling 22 laser surgical instruments because website promotional materials contained claims not applicable to US devices.

    Product
    Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coagulation and hemostasis of benign vascular lesions (e.g. port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg and spider veins, scars, straie and psoriasis
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-126-2013·2013-01-23

    Boehringer Ingelheim Recalls Perindopril Erbumine Tablets Due to Impurity

    Boehringer Ingelheim Roxane Inc. is recalling 3,553 bottles of Perindopril Erbumine Tablets, 8mg, because out-of-specification results were found for impurity B.

    Product
    Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0679-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling specific lots of GranuFlo Dry Acid Concentrate because the product may show discoloration.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.25 Ca 1Mg .16.5GAL Catalog Number: OFD2231-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0681-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis because the product may show discoloration.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75 Mg .16.5GAL Catalog Number: OFD2225-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0683-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis due to potential discoloration. The recall covers 670 units distributed nationwide.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,0 Ca 1.0Mg .16.5GAL Catalog Number: OFD3201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0678-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis due to potential discoloration. The recall covers 14,240 units distributed nationwide.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2.5 Ca 1Mg .16.5GAL Catalog Number: OFD3251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-127-2013·2013-01-23

    Upsher Smith Recalls Divalproex Sodium Tablets Due to Labeling Error

    Upsher Smith is recalling 11,316 bottles of Divalproex Sodium Delayed-Release Tablets because some labels are missing the color-coded strength indicator.

    Product
    Divalproex Sodium Delayed-Release Tablets, USP, 500 mg Valproic Acid Activity, 100-count tablets per bottle, Rx only, Manufactured by Upsher-Smith Laboratories, Inc., Minneapolis, MN 55447, NDC 0245-0182-11.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0684-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis due to potential discoloration. The recall covers 2,711 units distributed nationwide.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 3.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2325-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0677-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis because the product may show discoloration.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD2201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0676-2013·2013-01-23

    Fresenius GranuFlo Dry Acid Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis because the product may show discoloration.

    Product
    Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K 2.5 Ca 1 Mg 16.5 GAL Catalog Number: OFD2251-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0680-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate for hemodialysis due to potential discoloration. The recall covers 5 units distributed nationwide.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K 2.0 Ca 1Mg .16.5GAL Catalog Number: OFD1201-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-128-2013·2013-01-23

    Teva Recalls Cabergoline Tablets Due to Impurity Specification Failure

    Teva Pharmaceuticals is recalling 13,232 bottles of Cabergoline 0.5 mg tablets because the product may not meet impurity specifications over its shelf life.

    Product
    CABERGOLINE — CABERGOLINE (CABERGOLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0682-2013·2013-01-23

    Fresenius GranuFlo Dialysis Concentrate Recalled for Potential Discoloration

    Fresenius Medical Care is recalling GranuFlo Dry Acid Concentrate due to potential discoloration. The product is used for hemodialysis treatment.

    Product
    Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K 2,5 Ca 0.75Mg .16.5GAL Catalog Number: OFD2223-3B Product Usage: GranuFlo is indicated in the treatment of acute and chronic renal failure during the hemodialysis treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·13720·2013-01-22

    Siemens Recalls Q-Series Temperature and Humidity Sensors Due to Fire Hazard

    Siemens is recalling about 57,000 Q-Series temperature and humidity sensors for commercial buildings due to a fire hazard. Four overheating incidents and fires have been reported, with no injuries.

    Product
    Q-Series Temperature and Humidity Sensors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V018000·2013-01-22

    Great Dane Recalls 2013 Dry Freight Semi-Trailers Due to Axle Nut Clip Defect

    Great Dane Trailers is recalling 654 model year 2013 Dry Freight Semi-Trailers because axle nut retaining clips may not be properly seated, posing a risk of wheel separation.

    Product
    GREAT DANE — GREAT DANE DRY FREIGHT SEMI-TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V021000·2013-01-22

    Prevost Recalls 2013 Coach Buses for Missing Side Reflectors

    Prevost is recalling 45 model year 2013 coach buses and shells because they may have missing side reflectors, which could reduce visibility to other drivers.

    Product
    PREVOST — PREVOST XLII-45 ENTERTAINER, X3-45, H3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13E002000·2013-01-18

    Hayes Lemmerz Recalls Commercial Steel Wheels Due to Weld Defect

    Hayes Lemmerz is recalling specific commercial steel wheels because an inadequate weld may cause the wheel disc to separate from the rim, potentially leading to a vehicle crash.

    Product
    WHEELS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V016000·2013-01-18

    Honda Recalls Pilot and Odyssey Vehicles Due to Airbag Rivet Defect

    Honda is recalling 2009-2013 Pilot and 2011-2013 Odyssey vehicles because missing airbag rivets could alter driver airbag performance and increase injury risk during a crash.

    Product
    HONDA — HONDA PILOT, ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V019000·2013-01-17

    Navistar Recalls 2012-2013 IC Buses Due to Engine Shutdown Risk

    Navistar is recalling 1,276 IC brand buses because a wire may break, causing the engine to shut down unexpectedly while driving.

    Product
    IC BUS — IC BUS CASB, RE, RECB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V017000·2013-01-17

    BMW Recalls 2011 ActiveE Vehicles for Drivetrain Sealing Defect

    BMW is recalling 2011 ActiveE vehicles because insufficient sealing may cause loss of grease lubrication, potentially leading to a sudden loss of propulsion and increased crash risk.

    Product
    BMW — BMW ACTIVEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13099·2013-01-17

    Dolan Northwest Recalls Burien Floor Lamps Due to Shock and Fire Hazards

    Dolan Northwest is recalling Burien floor lamps because the foot switch can fail and melt, creating shock and fire risks. Consumers should stop using the lamps and return them for repair.

    Product
    Burien Floor Lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·13V015000·2013-01-17

    Prevost Recalls Coaches Due to Fire Suppression System Malfunction

    Prevost is recalling 2010-2013 H3, X3, and MTH XLII-45E coaches because the fire suppression system may activate unintentionally, causing an unplanned stop.

    Product
    PREVOST — PREVOST MTH XLII-45E, X3, H3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V020000·2013-01-17

    Navistar Recalls 2011-2013 Vehicles for Engine Shutdown Risk

    Navistar is recalling 7,657 vehicles from 2011-2013 because a wire may break, causing the engine to shut down unexpectedly while driving.

    Product
    IC BUS — IC BUS, INTERNATIONAL, HOLIDAY RAMBLER ICSB, 1300FBC, DURASTAR, WORKSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0874-2013·2013-01-16

    Pastry Food Products Recalls Pizza Mini Turnovers for Undeclared Milk

    Pastry Food Products Inc. is recalling TRIGAL Pastelillos Coctel de Pizza due to undeclared milk. The product was distributed in Puerto Rico.

    Product
    &TRIGAL***Pastelillos Coctel de Pizza (Pizza Mini turnovers)***12 ct***Pastry Foods Inc., Rio Piedras, PR&
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0875-2013·2013-01-16

    Multiexport Foods Recalls Farm-Raised Atlantic Salmon Due to Listeria

    Multiexport Foods, Inc. is recalling Paramount Reserve farm-raised Atlantic salmon after a private laboratory detected Listeria monocytogenes in a composite sample.

    Product
    Product labeled in part: ***PARAMOUNT RESERVE***PRODUCT OF CHILE FARM RAISED ATLANTIC SALMON PACKED BY: ALIMENTOS MULTIEXPORT S.A. *** DISTRIBUTED BY MULTIEXPORT FOODS INC. 703 WATERFORD WAY (NW 62ND AVE) SUITE 510, MIAMI, FL 33126***
    Category
    Food
    Distribution
    43 states
  • CriticalFDA (Food)·F-0867-2013·2013-01-16

    Capital City Fruit Recalls Cherry Tomatoes Due to Salmonella Risk

    Capital City Fruit Co. is recalling cherry tomatoes in 1-pint clamshells because they may be contaminated with Salmonella. The product was distributed to five states.

    Product
    Cherry tomatoes packaged in 1 pint clear, plastic clamshells. The clamshells are packaged either 9/1-pint clamshells or 12/1-pint clamshells per case.
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-0871-2013·2013-01-16

    Maplehurst Deli-Bake Recalls Publix Yellow Special Blend Layers for Listeria

    Maplehurst Deli-Bake South Inc is recalling Publix 7 Yellow Special Blend Layers found to be positive for Listeria monocytogenes.

    Product
    Publix 7 Yellow Special Blend Layers, Net Wt. 14.25 lbs. (24 count), frozen in bulk paper cartons to be frosted and sold individually at the retail stores.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0659-2013·2013-01-16

    Zimmer Ardis Interbody System Inserter Recalled for Release Knob Issues

    Zimmer, Inc. is recalling 170 Ardis Interbody System Inserters because the release knob may be difficult to turn, potentially leaving the implant engaged in the patient.

    Product
    The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the insert
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0868-2013·2013-01-16

    Whole Foods Recalls Kentucky Bleu and Blue Kentucky Rose Cheese

    Whole Foods Market is recalling specific cheeses sold in Louisville, KY, and Nashville, TN, due to potential safety concerns.

    Product
    Kentucky Bleu cheese was sold in the Louisville, KY, Whole Foods Market store, and was cut and packaged in clear plastic wrap. It was sold with a Whole Foods Market scale label reading 'Kenny's Farmhouse Cheese KY BL".
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0863-2013·2013-01-16

    S & M International Recalls Cooked Salted Duck Eggs

    S & M International Inc is recalling 200 cases of Yangsheng Cooked Salted Duck Eggs due to potential C. botulinum contamination.

    Product
    Yangsheng Duck Eggs Cooked Salted Duck Eggs Content:6 pieces Net Wt. 12.69 oz (360g) S&M (USA0 ENTERPRISE CORP. RED. B/T YUOXIU Bldg. 160-174 Lockhart Road, Man Chai, HK Distributed by: S&M INT'L. INC 100 Pulaski Stree
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0650-2013·2013-01-16

    California Medical Laboratories Recalls Rigid Tip Suction Wands Due to Tip Detachment Risk

    California Medical Laboratories is recalling Rigid Tip Suction Wands because the distal tip may detach and fall into a patient's chest cavity during surgery.

    Product
    Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0649-2013·2013-01-16

    California Medical Laboratories Recalls Sterile Rigid Tip Suction Wands

    California Medical Laboratories is recalling sterile rigid tip suction wands because the distal tip may detach and fall into a patient's chest cavity during surgery.

    Product
    Sterile Rigid Tip Suction Wand The Suction Wands are indicated for use to remove excess fluid from the surgical field.
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Food)·F-0869-2013·2013-01-16

    Whole Foods Recalls Blue Kentucky Rose Cheese in Kentucky and Tennessee

    Whole Foods Market is recalling specific Blue Kentucky Rose cheese products in Kentucky and Tennessee due to potential safety concerns.

    Product
    The Blue Kentucky Rose cheese sold in the Nashville, TN, Whole Foods Market store was cut and packaged in clear plastic wrap. It was sold with a Whole Foods Market scale label reading "Blue Kentucky Rose Kenny's".
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0872-2013·2013-01-16

    Maplehurst Deli-Bake South Recalls Publix Chocolate Split Layers for Listeria

    Maplehurst Deli-Bake South Inc. is recalling Publix 7 Chocolate Split Layers found to be positive for Listeria monocytogenes. The product was distributed in Florida and Georgia.

    Product
    Publix 7 Chocolate Split Layers, Net Wt. 12.75 lbs. (24 count), frozen in bulk paper cartons to be frosted and sold individually at the retail stores.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0865-2013·2013-01-16

    UNFI Recalls Kinnikinnick Gluten-Free Pie Crusts Due to Undeclared Eggs

    UNFI is recalling Kinnikinnick Gluten-Free Pie Crusts because they contain eggs that are not listed on the label.

    Product
    Kinnikinnick Pie Crust Gluten Free (frozen) weight 290 g/ 10 oz Qty/Pkg: 2, UPC 620133006229, Kinnikinnick Foods 10940 120 Street, Edmonton, AB Canada.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0873-2013·2013-01-16

    Pastry Food Products Recalls Trigel Pizza Turnovers for Undeclared Milk

    Pastry Food Products Inc. is recalling Trigel Empanadillas de Pizza due to undeclared milk. The product was distributed in Puerto Rico.

    Product
    &TRIGAL***Empanadillas de Pizza (Pizza turnovers)***12 ct***Pastry Foods Inc., Rio Piedras, PR&
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0651-2013·2013-01-16

    TissueNet Recalls UltraFill DBM Putty Due to Stainless Steel Particulates

    Surgical Tissue Network Inc. is recalling UltraFill DBM Putty-Porcine because the products may contain trace amounts of 316L Stainless Steel particulates.

    Product
    Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Product Code: RT53001 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DB
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0866-2013·2013-01-16

    Michael's Recalls Alaskan Wild Smoked Sockeye Salmon Due to Listeria

    Michael's Seafood Inc. is recalling Alaskan Wild Smoked Sockeye Salmon, Batch #1443, after a sample tested positive for Listeria monocytogenes.

    Product
    Alaskan Wild Smoked Sockeye Salmon in vacuum packed plastic package, labeled in part: "MICHAEL'S WILD SOCKEYE SMOKED SALMON***INGREDIENTS: WILD ALASKAN SOCKEYE SALMON, SALT, SUGAR, NATURAL HARDWOOD SMOKE.***KEEP FROZEN UNTIL USE/THAWED UNDER REFRIGERATION IMM
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0662-2013·2013-01-16

    Maquet Cardiosave Intra-Aortic Balloon Pump Recall for Cord Failure Risk

    Maquet is recalling 29 Cardiosave Intra-Aortic Balloon Pumps because the coiled cord assembly may fail if mishandled.

    Product
    CARDIOSAVE Intra-Aortic Balloon Pump An electromechanical system used to inflate and deflate intra-aortic balloons. It provide temporary support to the left ventricle via the principle of counterpulsation.
    Category
    Medical Device
    Distribution
    2 states
  • HighNHTSA·13V014000·2013-01-16

    Toyota Recalls Vehicles for Passenger Seat Occupant Sensing System Calibration

    Southeast Toyota Distributors is recalling specific 2009-2013 Toyota models because the passenger seat occupant sensing system may not be calibrated, potentially affecting airbag deployment.

    Product
    TOYOTA — TOYOTA PRIUS, CAMRY, CAMRY HYBRID, HIGHLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0658-2013·2013-01-16

    Zoll AutoPulse Resuscitation System Recalled for Unexpected Compression Stops

    Zoll Circulation is recalling AutoPulse Model 100 systems because they may stop compressions unexpectedly during use.

    Product
    AutoPulse Resuscitation System Model 100, Mfg by:Zoll Circulation Sunnyvale, CA. The AutoPulse Model 100 Automatic Mechanical Chest compressor is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spont
    Category
    Medical Device
    Distribution
    0 states

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