The Recall Desk

Archive

March 2013 recalls

461 recalls were announced in March 2013.

What the numbers show

Critical
39
Severe
115
High
192
Moderate
84
Low
31

Of the 461 recalls this month scored against our rubric, 8% are Critical, 25% are Severe.

1–100 of 461

  • SevereNHTSA·13V111000·2013-03-29

    Temsa Recalls 2013 TS35C Motorcoaches Due to Steering Lock Risk

    Temsa is recalling 25 model year 2013 TS35C motorcoaches because a steering column component may cause the wheel to lock, increasing crash risk.

    Product
    TEMSA — TEMSA TS35C
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13V112000·2013-03-29

    Mitsubishi Recalls 2013 Outlander Sport for Fuel Gauge Error

    Mitsubishi is recalling 2013 Outlander Sport AWD vehicles because a missing fuel sending unit harness may cause false fuel level readings, potentially leading to engine stalling.

    Product
    MITSUBISHI — MITSUBISHI OUTLANDER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13E015000·2013-03-28

    Thermo King Recalls T-Series and V-Series Temperature Control Units

    Thermo King is recalling specific T-Series and V-Series temperature control units due to a defect that may cause water intrusion and electrical short circuits, potentially leading to vehicle fires.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13157·2013-03-28

    Bell Sports Recalls BMX Helmets Due to Head Injury Risk

    Bell Sports is recalling about 2,500 Full Throttle BMX helmets because the safety strap buckle can release in an accident, posing a risk of head injury.

    Product
    Bell Full Throttle Bike Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13158·2013-03-28

    Definitive Technology Recalls SuperCube 2000 Subwoofers Due to Shock Risk

    Definitive Technology is recalling SuperCube 2000 subwoofers because an internal failure in the level input jack creates a shock hazard. Two consumers reported being shocked.

    Product
    SuperCube 2000 Powered Subwoofers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13155·2013-03-28

    BabyHome USA Recalls High Chairs Due to Strangulation Hazard

    BabyHome USA is recalling about 1,100 high chairs because the front opening can allow a child's body to pass through and become entrapped at the neck.

    Product
    Baby high chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1236-2013·2013-03-27

    IFF Recalls Beef for Potential Salmonella Contamination

    International Flavors & Fragrances, Inc. is recalling beef for potential Salmonella contamination. The product was distributed domestically and to Canada.

    Product
    Beef, IFF code: SN418156, Net Weight 50 lb, Batch 0004714076, Production date 04/23/2012, For Manufacturing use only.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1233-2013·2013-03-27

    International Flavors & Fragrances Recalls Chicken Flavor Seasoning for Salmonella Risk

    International Flavors & Fragrances is recalling Natural Chicken Flavor Seasoning due to potential Salmonella contamination. The product was distributed domestically and to Canada.

    Product
    Natural Chicken Flavor Seasoning, IFF Code: 3714201, Net Weight 50 lbs, Batch 0004706362, Production Date 04/25/2012, For Manufacturing Use Only.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1235-2013·2013-03-27

    IFF Recalls Natural Flavor Beef Product for Potential Salmonella Contamination

    International Flavors & Fragrances is recalling a specific batch of natural flavor beef product due to potential Salmonella contamination. The product was distributed domestically and to Canada.

    Product
    Nat Flv Beef FF, IFF Code 13580894, Net Weight 50 lb, Batch 0004702577, Production Date 04/23/2012, For Manufacturing Use Only.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1227-2013·2013-03-27

    Whole Foods Recalls Cold Smoked Salmon Spread Due to Listeria Risk

    Whole Foods Market is recalling cream cheese and cold smoked salmon spread because the salmon trim used was processed the same day as a sample testing positive for Listeria monocytogenes.

    Product
    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 (
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1126-2013·2013-03-27

    Pascalite Capsules Recalled for Potential Lead Contamination

    Pascalite, Incorporated is recalling Pascalite Capsules because they may contain violative levels of lead. The product is distributed in the U.S., Canada, UK, Hong Kong, and Australia.

    Product
    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.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1203-2013·2013-03-27

    Blue Planet Foods Recalls Heartland Granola Cereals Due to Ingredient Issue

    Blue Planet Foods is recalling Heartland granola cereals because they contain two recalled Dakota Specialty Milling ingredients.

    Product
    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
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1202-2013·2013-03-27

    Blue Planet Recalls Fruit and Nut Harvest Granola Cereal

    Blue Planet Foods is recalling Fruit & Nut Harvest Granola Cereal because it contains two recalled Dakota Specialty Milling ingredients.

    Product
    Heartland, AMERICA'S ORIGINAL, Fruit & Nut Harvest Granola Cereal, NET WT 14 OZ. (397g), UPC 024300090387
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V110000·2013-03-27

    Subaru Recalls 2005-2009 Legacy and Outback for Brake Line Corrosion

    Subaru is recalling 2005-2009 Legacy and Outback vehicles in 21 states and D.C. because salt water can corrode brake lines, potentially causing fluid leaks and increased stopping distances.

    Product
    SUBARU — SUBARU LEGACY, OUTBACK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-206-2013·2013-03-27

    Hospira Recalls Metronidazole Injection Bags Due to Sterility Concerns

    Hospira Inc. is recalling 567,624 bags of Metronidazole Injection due to a potential leak that compromises sterility.

    Product
    METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 (NDC 0409-7811-24)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-203-2013·2013-03-27

    Watson Recalls Meprobamate Tablets Due to Impurity Specification Failure

    Watson Laboratories is recalling meprobamate 200 mg tablets because an impurity, diphenyl sulfone, exceeded specification limits.

    Product
    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0965-2013·2013-03-27

    Boston Scientific SQ-RX Subcutaneous Pulse Generators Recalled for Fuse Activation

    Boston Scientific is recalling SQ-RX Model 1010 subcutaneous pulse generators because an internal fuse may activate unintentionally, preventing the device from delivering therapy.

    Product
    Boston Scientific/Cameron Health SQ-RX Model 1010 subcutaneous pulse generators. The S-ICD System is intended to provide therapy for the treatment of life-threatening ventricular tachyarrhythmias.
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Food)·F-1237-2013·2013-03-27

    International Flavors & Fragrances Recalls Beef Flavoring for Salmonella Risk

    International Flavors & Fragrances is recalling Nat Beef FF flavoring due to potential Salmonella contamination. The product was distributed domestically and to Canada.

    Product
    Nat Beef FF, Iff Code ULL89721, Net Weight 50 Lb, Batch 0004696310, Production Date 04/23/2012, For Manufacturing Use Only.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1238-2013·2013-03-27

    International Flavors & Fragrances Recalls Bean Sauce Seasoning for Salmonella Risk

    International Flavors & Fragrances is recalling 25 lb bags of Bean Sauce Seasoning due to potential Salmonella contamination. The product was distributed domestically and to Canada.

    Product
    Bean Sauce Seasoning, IFF Code: 76185, Net Weight 25 lb, Production date:04/26/2012, For Manufacturing use only.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-214-2013·2013-03-27

    Physicians Total Care Recalls Subpotent Levothyroxine Tablets

    Physicians Total Care is recalling Levothyroxine Tablets, USP, 0.175 mg, due to subpotency and stability issues. The recall affects specific lots distributed in Ohio and Georgia.

    Product
    Levothyroxine Tablets, USP (levothyroxine sodium), 0.175 mg, 30 count bottles, Rx, Repacked & distributed by: Physicians Total Care, Inc., Tulsa, OK --- NDC 54868-4507-00
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0971-2013·2013-03-27

    DePuy Specialist 2 IM Rod Recalled for Potential Breakage Risk

    DePuy Orthopaedics is recalling Specialist 2 IM Rods and associated surgical techniques due to a potential risk of the rod breaking and leaving fragments in patients.

    Product
    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1127-2013·2013-03-27

    Pascalite Powder Recalled for Potential Lead Contamination

    Pascalite, Incorporated is recalling Pascalite Powder products because they may contain violative levels of lead.

    Product
    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, deodor
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1201-2013·2013-03-27

    Blue Planet Recalls Heartland Harvest Spice Granola Cereal Nationwide

    Blue Planet Foods is recalling Heartland Harvest Spice Granola Cereal because it contains two recalled Dakota Specialty Milling ingredients.

    Product
    Heartland, AMERICA'S ORIGINAL, Harvest Spice Granola Cereal, NET WT 14 OZ. (397g), UPC 024300090394
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0953-2013·2013-03-27

    Exactech Recalls Knee Prosthesis Spacers Due to Dimensional Mismatch

    Exactech is recalling 123 Optetrak Logic knee prosthesis spacers and screws because a dimensional mismatch could allow interference between devices.

    Product
    Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1226-2013·2013-03-27

    Whole Foods Recalls Cold-Smoked Salmon Trim Due to Listeria Risk

    Whole Foods Market is recalling cold-smoked salmon trim sold in Washington and Oregon because a surveillance sample processed the same day tested positive for Listeria monocytogenes.

    Product
    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
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1242-2013·2013-03-27

    Dannon Light & Fit Vanilla Dairy Snack Recalled for Metal Fragments

    The Dannon Company is recalling Dannon Light & Fit Carb & Sugar Control Vanilla dairy snacks because they may contain metal fragments from a faulty manufacturing part.

    Product
    Dannon Light & Fit Carb & Sugar Control Cultured Dairy Snack Vanilla Flavor 4x4oz cups
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1248-2013·2013-03-27

    Conagra Recalls Great Value Salsa Due to Potential Plastic Contamination

    Conagra is recalling Great Value All Natural Hot Chunky Salsa because the product may contain plastic pieces.

    Product
    Great Value All Natural Hot Chunky Salsa, 24 oz (1lb 8oz) 680 g.; UPC 0078745208641; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR
    Category
    Food
    Distribution
    24 states
  • SevereFDA (Food)·F-1205-2013·2013-03-27

    Blue Planet Foods Recalls Pre-Baked Crisp Topping for Contaminated Ingredients

    Blue Planet Foods is recalling Orth Transmart Pre-Baked Crisp Topping because it contains two recalled Dakota Specialty Milling ingredients.

    Product
    #38605020 ORTH TRANSMART(TM) PRE-BAKED CRISP TOPPING, NET WEIGHT 30 LBS. (13.6 kg)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V109000·2013-03-27

    Ford Recalls 2012 Taurus, MKS, and 2013 Explorer for Fuel Tank Defect

    Ford is recalling specific 2012 Taurus, Lincoln MKS, and 2013 Explorer vehicles because fuel tanks may leak or fail in an impact, posing a fire risk.

    Product
    FORD — FORD, LINCOLN TAURUS, MKS, EXPLORER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1228-2013·2013-03-27

    Whole Foods Recalls Bagels With Cold Smoked Salmon Due To Listeria Risk

    Whole Foods Market is recalling bagels with cold smoked salmon spread because the salmon trim used was processed alongside a sample testing positive for Listeria monocytogenes.

    Product
    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 WH
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1213-2013·2013-03-27

    Arnold Healthfull Multigrain Bread Recalled for Possible Flexible Wire Presence

    Bimbo Bakeries USA is voluntarily recalling Arnold Healthfull 45 Calories Per Slice Multigrain Bread due to the possible presence of flexible wire.

    Product
    Arnold Healthfull 45 Calories Per Slice Multigrain Bread, 1 LB 2 OZ (510g)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1207-2013·2013-03-27

    Blue Planet 9 Grain Granola Recalled for Contaminated Ingredients

    Blue Planet Foods is recalling 9 Grain Granola because it contains two recalled Dakota Specialty Milling ingredients.

    Product
    Blue Planet, 10311 9 Grain Granola, NET WEIGHT 900 lbs (bulk product)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1241-2013·2013-03-27

    Dannon Activia Light Yogurt Recalled for Potential Metal Fragments

    The Dannon Company is recalling Dannon Activia LIGHT Nonfat Yogurt in strawberry and blueberry flavors because the product may contain metal fragments from a faulty manufacturing part.

    Product
    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***U
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1229-2013·2013-03-27

    Dymatize Nutrition XPAND Post Xtreme Mass Recovery System Recalled for Allergen Mislabeling

    Dymatize Nutrition XPAND Post Xtreme Mass Recovery System is being recalled because the label declares whey but fails to declare milk.

    Product
    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
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0968-2013·2013-03-27

    Spacelabs Anesthesia Workstation Recall for Carbon Dioxide Defect

    Del Mar Reynolds Medical is recalling Spacelabs anesthesia workstations and service kits containing CAS I/II Absorbers due to a defect that may increase carbon dioxide levels in patient gas.

    Product
    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 installed with the CAS I/II Absorber. Anesthesia workstation for use in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0972-2013·2013-03-27

    DePuy ReClaim Reamer Extension Recalled Due to Broken Tabs

    DePuy Orthopaedics is recalling 750 ReClaim Reamer Extension devices because tabs may break and remain in patients during surgery.

    Product
    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.
    Category
    Medical Device
    Distribution
    27 states
  • HighFDA (Devices)·Z-0959-2013·2013-03-27

    Allen Medical Systems Recalls Traction Boots Due to Assembly Defect

    Allen Medical Systems is recalling 24 traction boots because incorrect assembly could cause the boot to detach, allowing a patient's leg to fall during surgery.

    Product
    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
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-1240-2013·2013-03-27

    Dannon Activia LIGHT Nonfat Yogurt Recalled for Potential Metal Fragments

    The Dannon Company is recalling Dannon Activia LIGHT Nonfat Yogurt Peach Flavor 4x4oz cups because they may contain metal fragments from a faulty manufacturing part.

    Product
    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
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0962-2013·2013-03-27

    DePuy Spine Recalls Cement Mixer Kits Due to Jamming Risk

    DePuy Spine is recalling CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus kits because the cement mixer may jam or fail to turn properly during surgery.

    Product
    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0960-2013·2013-03-27

    DePuy Confidence Spinal Cement Mixer Recall for Jamming Defect

    DePuy Spine is recalling the Confidence Spinal Cement System 5cc Kit because the cement mixer may not turn properly and may jam or get stuck during surgery.

    Product
    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1239-2013·2013-03-27

    Pan-O-Gold Recalls Rye Bread Due to Potential Stainless Steel Wire Contamination

    Pan-O-Gold Baking Co. is recalling 8,274 loaves of rye bread sold in eight states due to a potential risk of stainless steel wire contamination from a disintegrated sifter screen.

    Product
    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, Dist
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-1234-2013·2013-03-27

    International Flavors & Fragrances Recalls Beef Marrow Flavoring Due to Salmonella Risk

    International Flavors & Fragrances is recalling specific batches of beef marrow flavoring due to potential Salmonella contamination. The product was distributed domestically and to Canada.

    Product
    Nat Flavor Beef Marrow, IFF Code: ULL681883, Net Weight 50 lb, Batch 0004684926, Production Date 04/25/2012, For Manufacturing Use Only.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0963-2013·2013-03-27

    DePuy Spine Recalls CONFIDENCE Spinal Cement System Kits

    DePuy Spine is recalling CONFIDENCE Spinal Cement System Kits because the cement mixer may not turn properly and could jam or get stuck during surgery.

    Product
    DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1208-2013·2013-03-27

    Ron's Pizza Warehouse Recalls Unlabeled Pizza Dough Shells Containing Wheat

    Ron's Pizza Warehouse is recalling approximately 700 pizza dough shells in Ohio because the product contains wheat but lacks allergen labeling.

    Product
    The pizza dough shells come in 5 lb. brown cardboard boxes, containing 25 shells per box.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0955-2013·2013-03-27

    Vascular Solutions Recalls Guardian II Hemostasis Valves Due to Air Embolism Risk

    Vascular Solutions, Inc. is recalling Guardian II and Guardian II NC Hemostasis Valves used in cardiopulmonary bypass because air may be introduced into the device, potentially leading to an air embolism.

    Product
    Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: 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 Ze
    Category
    Medical Device
    Distribution
    43 states
  • HighFDA (Devices)·Z-0961-2013·2013-03-27

    DePuy Spine Recalls Cement Mixer Kits Due to Jamming Risk

    DePuy Spine is recalling 549 CONFIDENCE Spinal Cement System kits because the cement mixer may jam or fail to turn properly during surgery.

    Product
    DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. Delivery of CONFIDENCE Spinal Cement, which is indicated for fixation of pathological fractures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1209-2013·2013-03-27

    NuGo Free Trail Mix Bars Recalled for Possible Milk Presence

    NuGo Nutrition HQ is recalling NuGo Free Trail Mix Bars due to the possible inadvertent presence of milk. The product was distributed only in Canada.

    Product
    NuGo Free Trail Mix Bars, UPC 6 91535 45301 2
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0969-2013·2013-03-27

    Molded Products Recalls Sterile Hemodialysis Line Sets Due to Leaks

    Molded Products Inc is recalling 1,200 sterile access and return line sets used in hemodialysis because they leak at the connection site.

    Product
    Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1211-2013·2013-03-27

    Bimbo Recalls Arnold Dutch Country Bread Due to Possible Wire Presence

    Bimbo Bakeries USA is voluntarily recalling Arnold Dutch Country 100% Whole Grain Bread due to the possible presence of flexible wire from a faulty screen at a flour mill.

    Product
    Arnold Dutch Country 100% Whole Grain Bread, 1 LB 8 OZ (680g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1221-2013·2013-03-27

    Harmons Multi-Grain Bread Recalled for Possible Flexible Wire Presence

    Bimbo Bakeries USA is voluntarily recalling Harmons 100% Multi-Grain Wide Pan Oven-Baked Bread due to the possible presence of flexible wire from a faulty screen at a third-party flour mill.

    Product
    Harmons 100% Multi-Grain Wide Pan Oven-Baked Bread, NET WT 24 OZ (1LB 8 OZ) 680g
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0952-2013·2013-03-27

    Extremity Medical Recalls Undersized 1.6 mm Orthopedic Guidewires

    Extremity Medical LLC is recalling 238 non-sterile 1.6 mm guidewires because they are undersized, causing depth gauge readings to select screws approximately 2 mm longer than intended.

    Product
    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 appropriat
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-1212-2013·2013-03-27

    Bimbo Recalls Brownberry Bread Due to Possible Wire Contamination

    Bimbo Bakeries USA is voluntarily recalling Brownberry Dutch Country 100% Whole Grain Bread due to the possible presence of flexible wire from a faulty screen at a third-party flour mill.

    Product
    Brownberry Dutch Country 100% Whole Grain Bread, 1 LB 8 OZ (680g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1214-2013·2013-03-27

    Bimbo Recalls Stroehmann Bread Due to Possible Wire Contamination

    Bimbo Bakeries USA is voluntarily recalling Stroehmann Dutch Country 100% Whole Grain Bread due to the possible presence of flexible wire from a faulty screen at a third-party flour mill.

    Product
    Stroehmann Dutch Country 100% Whole Grain Bread, 1 LB 8 OZ (680g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1232-2013·2013-03-27

    IFF Recalls Grilled Chicken Marinade Due to Salmonella Risk

    International Flavors & Fragrances is recalling specific batches of Grilled Chicken Marinade due to potential Salmonella contamination.

    Product
    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.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1217-2013·2013-03-27

    Bimbo Recalls Brownberry Double Protein Bread Due to Possible Wire Presence

    Bimbo Bakeries USA is voluntarily recalling Brownberry Grains & More Double Protein Bread due to the possible presence of flexible wire from a flour supplier.

    Product
    Brownberry Grains & More Double Protein Bread, 1 LB 8 OZ (680g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1215-2013·2013-03-27

    Aldi L'Oven Fresh Hearty 12 Grain Bread Recalled for Wire Contamination

    Bimbo Bakeries USA is voluntarily recalling Aldi L'Oven Fresh Hearty 12 Grain Bread due to the possible presence of flexible wire from a faulty screen at a third-party flour mill.

    Product
    Aldi L'Oven Fresh Hearty 12 Grain Bread, NET WT 24 OZ (1 LB 8 OZ) 680g
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1219-2013·2013-03-27

    Bimbo Bakeries Recalls Earthgrains Bread Due to Possible Wire Presence

    Bimbo Bakeries USA is voluntarily recalling Earthgrains 12 Grain Natural Bread because a faulty screen at a flour mill may have introduced flexible wire into the product.

    Product
    Earthgrains 12 Grain Natural Bread, NET WT 1 LB 8 OZ (680g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1220-2013·2013-03-27

    Bimbo Bakeries Recalls Farm Bread Multi-Grain Due to Wire Risk

    Bimbo Bakeries USA is voluntarily recalling Farm Bread All Natural Multi-Grain because a faulty screen at a flour supplier may have introduced flexible wire into the product.

    Product
    Farm Bread All Natural Multi-Grain, NET WT 24 OZ (1 LB 8 OZ) 680g
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1216-2013·2013-03-27

    Bimbo Recalls Brownberry Nutty Grain Bread Due to Wire Contamination

    Bimbo Bakeries USA is voluntarily recalling Brownberry Healthfull Nutty Grain Bread because it may contain flexible wire fragments from a faulty screen at a flour supplier.

    Product
    Brownberry Healthfull Nutty Grain Bread, 1 LB 8 OZ (680g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1222-2013·2013-03-27

    Sara Lee Multi-Grain Buns Recalled for Possible Flexible Wire Presence

    Bimbo Bakeries USA is voluntarily recalling Sara Lee Multi-Grain Thin Style Buns due to the possible presence of flexible wire from a faulty screen at a third-party flour mill.

    Product
    Sara Lee Multi-Grain Thin Style Buns, NET WT 12 OZ (340g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0954-2013·2013-03-27

    Biomet Spine Polaris Screw Inserter Recalled for Tip Failure Risk

    Ebi, LLC is recalling 59 units of the Biomet Spine Polaris 5.5 Button Lock Screw Inserter due to an increased risk of failure at the driver tip during use.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1247-2013·2013-03-27

    Conagra Recalls Great Value Salsa Due to Potential Plastic Contamination

    Conagra is recalling Great Value All Natural Medium Chunky Salsa because the product may contain plastic pieces. Consumers should stop using the affected items.

    Product
    Great Value All Natural Medium Chunky Salsa, 24 oz (1lb 8oz) 680 g.; UPC 007874208640; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-1230-2013·2013-03-27

    Dymatize Nutrition XPAND Post Xtreme Mass Recovery System Recalled for Undeclared Milk

    Dymatize Enterprises is recalling specific lots of XPAND Post Xtreme Mass Recovery System Fruit Punch because the label declares whey but fails to declare milk.

    Product
    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.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1210-2013·2013-03-27

    Bimbo Recalls Brownberry Multigrain Bread Due to Possible Wire Presence

    Bimbo Bakeries USA is voluntarily recalling Brownberry Healthfull Multigrain Bread due to the possible presence of flexible wire from a faulty screen at a flour supplier.

    Product
    Brownberry Healthfull 45 Calories Per Slice Multigrain Bread, 1 LB 2 OZ (510g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1231-2013·2013-03-27

    Dymatize Nutrition XPAND Post Xtreme Mass Recovery System Recalled for Undeclared Milk

    Dymatize Enterprises is recalling specific lots of XPAND Post Xtreme Mass Recovery System because the label declares whey but fails to declare milk.

    Product
    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.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1218-2013·2013-03-27

    Sara Lee 12 Grain Bread Recalled for Possible Wire Contamination

    Bimbo Bakeries USA is recalling Sara Lee 12 Grain Bread due to the possible presence of flexible wire from a flour supplier.

    Product
    Sara Lee 12 Grain Bread Hearty & Delicious, 24 OZ (1LB 8OZ) 680g
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0956-2013·2013-03-27

    Synthes Recalls Four Mis-etched Variable Angle Locking Compression Plates

    Synthes USA is recalling four Variable Angle Locking Compression Plates that were incorrectly etched with the wrong part number.

    Product
    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.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Food)·F-1246-2013·2013-03-27

    Great Value Salsa Mild Recalled for Potential Plastic Contamination

    Conagra is recalling Great Value Salsa Mild because the product may contain plastic pieces. Consumers should stop using the product.

    Product
    Great Value Salsa Mild, 16 oz (1lb) 454 g.; UPC 007874212780; Distributed by: Wal-Mart Stores, Inc, Bentonville, AR
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-0973-2013·2013-03-27

    Keystone Dental Recalls Mislabeled PrimaConnex Tapered Dental Implants

    Keystone Dental Inc is recalling 120 units of PrimaConnex Tapered Implants because the included cover screw was a WD type instead of the labeled SD type.

    Product
    PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Drugs)·D-205-2013·2013-03-27

    Watson Recalls Zarah Oral Contraceptive Tablets Due to Breakage

    Watson Laboratories is recalling Zarah oral contraceptive tablets because they may break while being pushed through the blister pack.

    Product
    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0958-2013·2013-03-27

    Beckman Coulter Recalls Creatinine Reagents for Calibration Instructions

    Beckman Coulter is recalling Creatinine reagents to provide updated instructions for calibration stability and quality control frequency.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0964-2013·2013-03-27

    Stryker Specialty Triathlon Knee Sizer Adjustment Housing Recalled for Fit and Marking Errors

    Stryker is recalling four units of Specialty Triathlon Knee Sizer Adjustment Housings because the standard femoral stylus does not fit and the left/right markings on the right sizer are reversed.

    Product
    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
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0967-2013·2013-03-27

    Alphatec ILLICO Spinal Rods Recalled for Incorrect Length Marking

    Alphatec Spine is recalling 7 ILLICO spinal rods that were laser-etched as 110mm but are actually 100mm long.

    Product
    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 fix
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0957-2013·2013-03-27

    Siemens Tacrolimus Reagent Cartridge Recalled for Low Sample Recovery

    Siemens is recalling 2,976 Dimension Tacrolimus Flex reagent cartridges due to confirmed low patient sample recovery and a 25% low bias compared to LC/MS.

    Product
    Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in vitro diagnostic test.
    Category
    Medical Device
    Distribution
    20 states
  • ModerateFDA (Drugs)·D-204-2013·2013-03-27

    Watson Recalls Meprobamate Tablets Due to Impurity Failure

    Watson Laboratories is recalling meprobamate 400 mg tablets because an impurity, diphenyl sulfone, exceeded specification limits.

    Product
    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1244-2013·2013-03-27

    Wynlife Recalls Probiotics and Vegi-Fiber Plus Due to DEHP Contamination

    Wynlife Healthcare is recalling All-In-One Probiotics and Vegi-Fiber Plus products because they contain DEHP-contaminated clouding agents.

    Product
    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. Manufac
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1243-2013·2013-03-27

    Wynlife Recalls Vegi-Fiber Plus and Probiotics Due to DEHP Contamination

    Wynlife Healthcare is recalling Vegi-Fiber Plus and All-In-One Probiotics because they contain DEHP-contaminated clouding agents.

    Product
    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 fo
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1245-2013·2013-03-27

    Conagra Recalls Great Value Salsa Due to Potential Plastic Contamination

    Conagra Inc is recalling Great Value All Natural Mild Chunky Salsa because the product may contain plastic pieces.

    Product
    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
    Category
    Food
    Distribution
    24 states
  • LowFDA (Devices)·Z-0966-2013·2013-03-27

    Volk Optical Recalls 20 Diopter Binocular Indirect Ophthalmoscope Lenses

    Volk Optical Inc is recalling 40 units of 20 Diopter Binocular Indirect Ophthalmoscope lenses due to mixed-up lot number engravings on the devices and packaging.

    Product
    20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
    Category
    Medical Device
    Distribution
    6 states
  • LowFDA (Drugs)·D-210-2013·2013-03-27

    Novartis Recalls Nasal Spray Due to Illegible Lot and Expiration Dates

    Novartis Consumer Health is recalling 4 way Nasal Decongestant Menthol Nasal Spray because lot numbers and expiration dates may be illegible.

    Product
    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0974-2013·2013-03-27

    Intio ClearStart-SVM User Manual Recalled for Editing Mistake

    Intio Inc. is recalling seven copies of the ClearStart-SVM User Manual due to an editing mistake that could be interpreted as promoting an unapproved use.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1224-2013·2013-03-27

    MET-Rx Extreme NOS Pumped Double Berry Recalled for Commercial Spoilage

    NBTY Inc. is recalling 5,412 bottles of MET-Rx Extreme NOS Pumped Double Berry dietary supplement because the product's color, odor, and taste have changed, failing quality standards.

    Product
    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 Ra
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-208-2013·2013-03-27

    Novartis Recalls Nupercainal Ointment Due to Illegible Labeling

    Novartis Consumer Health is recalling Nupercainal Ointment because lot numbers and expiration dates may be illegible or missing.

    Product
    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1223-2013·2013-03-27

    NBTY Recalls MET-Rx Extreme NOS Pumped Watermelon Dietary Supplement

    NBTY Inc. is recalling 28,068 bottles of MET-Rx Extreme NOS Pumped Watermelon dietary supplement due to commercial spoilage affecting the product's color, odor, and taste.

    Product
    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 Rato
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-209-2013·2013-03-27

    Novartis Recalls 4 Way Nasal Spray Due to Illegible Labeling

    Novartis Consumer Health is recalling 4 Way Nasal Spray because lot numbers and expiration dates may be illegible.

    Product
    4 WAY — 4 WAY (PHENYLEPHRINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-211-2013·2013-03-27

    Novartis Recalls 4 Way Saline Moisturizing Mist Due to Labeling Errors

    Novartis Consumer Health is recalling 4 Way Saline Moisturizing Mist bottles because lot numbers or expiration dates may be illegible or missing.

    Product
    4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC. Distributed by Novartis Consumer Health, Inc., Parsippany, NJ 07054.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1225-2013·2013-03-27

    MET-Rx Extreme NOS Pumped Nitro-Punch Recalled for Commercial Spoilage

    NBTY Inc. is recalling 1,176 bottles of MET-Rx Extreme NOS Pumped Nitro-Punch dietary supplement because the product's color, odor, and taste have changed, failing quality standards.

    Product
    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
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0970-2013·2013-03-27

    Agfa X-Ray Image Plate Recall Due to Incorrect Barcode Labeling

    Agfa Corp. is recalling 17 X-ray image plates shipped with incorrect size barcodes, affecting facilities in 10 US states.

    Product
    CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate 35CM X 43CM. An image plate, contained in an X-Ray cassette, used to capture images from X-Ray exposures. The cassette with the image plate, once exposed, is inserted in the Agfa Digitizer CR 10-X where the ima
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-201-2013·2013-03-27

    West-ward Recalls Carisoprodol Tablets for Missing C-IV Labeling

    West-ward Pharmaceutical Corp. is recalling 1,763 bottles of Carisoprodol Tablets, 350 mg, because they lack the required C-IV imprint on the label.

    Product
    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-207-2013·2013-03-27

    Novartis Recalls Myoflex Cream Due to Illegible Lot and Expiration Dates

    Novartis Consumer Health is recalling Myoflex Pain Relieving Cream because lot numbers and expiration dates may be illegible. The recall covers 2-oz and 4-oz tubes distributed nationwide and in Panama.

    Product
    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V108000·2013-03-26

    NABI Recalls 2012-2013 40LFW Transit Buses for Brake Pedal Defect

    North American Bus Industries is recalling 84 model year 2012-2013 40LFW transit buses because brake pedals may not fully release, potentially causing overheating and fire.

    Product
    NABI — NABI 40LFW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13154·2013-03-26

    3M Recalls Filtrete Room Air Purifiers Due to Fire Hazard

    3M is recalling about 10,000 Filtrete room air purifiers because the ion generator can overheat and cause a fire. No injuries or property damage have been reported.

    Product
    Filtrete™ room air purifiers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13152·2013-03-26

    WRSI Recalls Kayaking and Rafting Helmets Due to Chinstrap Failure

    WRSI is recalling about 2,200 whitewater kayaking and rafting helmets because the chinstrap buckle can fail, posing a head injury hazard.

    Product
    Whitewater Kayaking and Rafting Helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·13151·2013-03-26

    PT Domusindo Perdana Recalls Drop-Side Cribs Due to Entrapment Hazards

    PT Domusindo Perdana is recalling about 73,000 drop-side cribs sold at JCPenney because the drop sides can malfunction, posing entrapment and suffocation risks to infants.

    Product
    PT Domusindo Perdana drop-side cribs
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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