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.

24751–24775 of 32193

  • SevereFDA (Devices)·Z-0016-2015·2014-10-15

    Richard-Allan Scientific Recalls 10% Neutral Buffered Formalin Due to Concentration Issues

    Richard-Allan Scientific is recalling 199 cases of 10% Neutral Buffered Formalin because the chemical concentration may be outside of desired specifications.

    Product
    Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0018-2015·2014-10-15

    Cardinal Health Prefilled Buffered 10% Formalin Recalled for Concentration Issues

    Richard-Allan Scientific Company is recalling Cardinal Health Prefilled Buffered 10% Formalin because the formalin concentration may be outside specifications.

    Product
    Cardinal Health Prefilled Buffered 10% Formalin. Product Usage:10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0006-2015·2014-10-15

    Janssen Recalls Xarelto Tablets Due to Microbial Contamination

    Janssen Ortho L.L.C. is recalling 13,500 bottles of Xarelto (rivaroxaban) 15 mg tablets due to confirmed microbial contamination in a sales sample.

    Product
    Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0012-2015·2014-10-15

    Richard-Allan Scientific Recalls Protocol 10% NBF Tissue Fixative

    Richard-Allan Scientific is recalling 175 cases of Protocol 10% NBF tissue fixative because the concentration may be outside specifications.

    Product
    Protocol 10% NBF Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0005-2015·2014-10-15

    Publix Jalapeno Bagels Recalled for Potential Glass and Stone Contamination

    Publix Super Markets is recalling Jalapeno Bagels sold in Alabama, Florida, Georgia, and South Carolina because they may contain pieces of glass and small stones.

    Product
    Publix brand Jalapeno Bagels, sold in self service bins and counter sales.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0058-2015·2014-10-15

    Biomet Recalls Mamba Disposable Nitinol Needles Due to Breakage Risk

    Biomet is recalling 164 Mamba Disposable Nitinol Needles because high friction may cause the needles to break during use.

    Product
    Mamba Disposable Nitinol Needle. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The Mamba Needle is designed for use with the Mamba Suture Passer. The needles are sterile, disposable, and for single-patient use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0003-2015·2014-10-15

    Brilliant Cake Biscuits Recalled for Undeclared Eggs and Unapproved Colors

    Domega NY International Co Ltd is recalling Brilliant Cake with Filling Milk (Biscuits) due to undeclared eggs and unapproved food colors.

    Product
    Brilliant Cake with Filling Milk (Biscuits), NET WT 13.9 oz (396 g), UPC 6 908166 500140, Product of China --- The product is packed in a plastic wrapped package.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0007-2015·2014-10-15

    Zydus Recalls Atenolol Tablets Due to Superpotent Drug Complaint

    Zydus Pharmaceuticals is recalling 5,400 bottles of Atenolol 25 mg tablets nationwide after a pharmacist reported that several tablets appeared noticeably thicker.

    Product
    ATENOLOL — ATENOLOL (ATENOLOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0009-2015·2014-10-15

    Mylan Recalls Metoprolol Succinate Tablets Due to Foreign Object Presence

    Mylan Pharmaceuticals is recalling 15,966 bottles of Metoprolol Succinate Extended-release Tablets 50mg because a pharmacist reported finding a rogue tablet of different size and markings in a bottle.

    Product
    Metoprolol Succinate Extended-release Tablets, USP 50mg, 90-count Bottles, Rx only, Mfg by Mylan Pharmaceuticals, Inc. Morgantown, WV 26505. NDC 0378-4596-77.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0018-2015·2014-10-15

    SABA ACE Appetite Control Energy Recalled for DMAA Presence

    AMS Health Sciences is recalling SABA ACE products manufactured before September 2013 due to the presence of DMAA.

    Product
    saba; ACE; Appetite Control Energy; 052234; 07/2015; Distributed by Saba; 711 NE 39th Street, Oklahoma City, OK 73105
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0002-2015·2014-10-15

    Starway Inc. Recalls Peony Mark Roasted and Salted Pumpkin Seeds

    Starway Inc. is recalling Peony Mark brand roasted and salted pumpkin seeds due to undeclared sulfites. The product was distributed in New York, New Jersey, Massachusetts, and Michigan.

    Product
    PEONY MARK brand ROASTED AND SALTED PUMPKIN SEED, NET WT. 12 oz. (340 gm), Barcode 6 932692 225765, PRODUCT OF CHINA --- PACKED FOR: STARWAY INC 137 GRATTAN STREET, BROOKLYN, NEW YORK 11237 --- NUTRITION FACTS: Serving Size 1 oz., Servings per container 12
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0014-2015·2014-10-15

    Richard-Allan Scientific Recalls 10% Neutral Buffered Formalin Due to Concentration Issues

    Richard-Allan Scientific is recalling 10% Neutral Buffered Formalin because the concentration may be outside specifications. The product is used to fixate tissue for histological examination.

    Product
    Richard-Allan Scientific 10% Neutral Buffered Formalin. Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·069-2014·2014-10-14

    Italian Style Wedding Soup Recalled for Undeclared Soy and Egg Allergens

    Fresh Food Manufacturing is recalling 1,008 pounds of Italian Style Wedding Soup because the label failed to declare soy and egg allergens.

    Product
    Fresh Food Manufacturing Company — Pennsylvania Firm Recalls Italian Style Wedding Soup Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·14V643000·2014-10-14

    Chrysler Recalls 2014 Dodge Durango and Jeep Grand Cherokee for Airbag Fault

    Chrysler is recalling 2014 Dodge Durango and Jeep Grand Cherokee vehicles because a module fault may disable airbags and seat belt pretensioners, increasing injury risk in crashes.

    Product
    DODGE — DODGE, JEEP DURANGO, GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V646000·2014-10-14

    Vermeer Recalls 2014 TR620 Trailers Due to Hitch Mount Defect

    Vermeer is recalling 2014 TR620 Trommel trailers because an incorrect material in the pintle hitch mount may allow bolts to loosen, increasing crash risk.

    Product
    VERMEER — VERMEER TR620
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·067-2014-EXP·2014-10-13

    Galant Food Company Recalls Additional Beef Piroshki Due to Processing Flaw

    Galant Food Company is recalling an additional 130 pounds of beef piroshki because the meat filling did not reach the required cooking temperature.

    Product
    Galant Food Co — California Firm Expands Recall of Beef Products Due To Possible Processing Flaw
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14V638000·2014-10-10

    Strick Dry Freight Van Trailers Recalled for Rear Impact Guard Defect

    Strick Trailers is recalling 2009-2015 Dry Freight Van Trailers because rear impact guards do not meet federal safety standards, increasing injury risk in crashes.

    Product
    STRICK — STRICK DRY FREIGHT VAN TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V642000·2014-10-10

    Wheeled Coach Recalls Ambulances Due to Suspension Tank Mount Failure Risk

    Wheeled Coach is recalling certain 2013-2015 ambulances because a suspension fluid tank mount may fail, causing the tank to separate and create a road hazard.

    Product
    WHEELED COACH — WHEELED COACH TYPE III AMBULANCE, TYPE I AMBULANCE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0001-2015·2014-10-08

    CUBICIN daptomycin injection vials recalled due to potential glass particulate matter

    The FDA is recalling CUBICIN daptomycin injection vials because there may be glass particles present in the vials.

    Product
    CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2535-2014·2014-10-08

    Boskovich Farms Recalls Diced Roma Tomatoes Due to Salmonella Risk

    Boskovich Farms is recalling diced Roma tomatoes because they may be contaminated with Salmonella. The affected product was distributed in California.

    Product
    2-5 lb. clear plastic overwrapped black poly trays of 3/8" diced Roma Tomato per cardboard carton. Cardboard carton labeled: 2-5 LB. DICED TOMATOES 3/8  PACKED BY BOSKOVICH FARMS OXNARD CA, 93030 PRODUCT OF MEXICO.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1615-2014·2014-10-08

    Sagent Recalls Zoledronic Acid Injection Due to Sterility Concerns

    Sagent Pharmaceuticals is recalling 10,622 bags of Zoledronic Acid Injection because of a lack of assurance of sterility and leaking premix bags.

    Product
    ZOLEDRONIC ACID — ZOLEDRONIC ACID (ZOLEDRONIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide