The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

28576–28600 of 32252

  • 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
  • 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 (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 (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-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
  • 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…
    Category
    Food
    Distribution
    2 states
  • 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…
    Category
    Food
    Distribution
    2 states
  • SevereFDA (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
  • 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
  • SevereFDA (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
  • 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 (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…
    Category
    Medical Device
    Distribution
    43 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 (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 (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
  • 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
  • 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 (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…
    Category
    Food
    Distribution
    0 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-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
  • 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-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
  • 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