The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. 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.

10951–10975 of 29159

  • SevereUSDA FSIS·108-2019·2019-11-06

    Simmons Prepared Foods Recalls Poultry Products Due to Metal Contamination

    Simmons Prepared Foods is recalling approximately 2.07 million pounds of poultry products that may contain metal. The products were shipped to institutions in eight states.

    Product
    Simmons Prepared Foods, Inc. — Simmons Prepared Foods, Inc. Recalls Poultry Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-0128-2020·2019-11-06

    Peekay International Recalls Dry Apricots Due to Undeclared Sulfites

    Peekay International Inc. is recalling specific brands of dry apricots because they contain undeclared sulfites. The product was distributed in six states.

    Product
    Bulk Dry Apricot in clear plastic bags inside brown cardboard box and Swan brand Dry Appricot & Keshav brand Dry Apricot in 7oz and 14oz clear plastic bags. Imported & Distributed By: Peekay International Inc. 56-12 56th Street, Maspeth, New York - 11378. U.S.A. Keshav 7oz UPC:
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0221-2020·2019-11-06

    Thoratec CentriMag Motor Recalled Due to Electromagnetic Interference Issues

    Thoratec is recalling CentriMag Acute Circulatory Support System motors due to reports of motor and pump issues caused by electromagnetic interference.

    Product
    CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0200-2020·2019-11-06

    Ethicon Echelon Flex Endopath Stapler Recall for Out-of-Spec Anvil

    Ethicon is recalling Echelon Flex Endopath 60mm Staplers due to out-of-specification anvil components that may compromise staple line integrity.

    Product
    ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0202-2020·2019-11-06

    Ethicon Echelon Flex Powered Plus Endopath 60mm Stapler Recall

    Ethicon is recalling 5,040 Echelon Flex Powered Plus Endopath 60mm Staplers due to out-of-specification anvil components that may compromise staple line integrity.

    Product
    ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm shaft, Product Code PLEE60A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0201-2020·2019-11-06

    Ethicon Recalls ECHELON FLEX Staplers Due to Anvil Defect

    Ethicon Endo-Surgery Inc is recalling 255 units of the ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler because an out-of-specification anvil may cause malformed staples and compromised staple lines.

    Product
    ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code PCEE60A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0165-2020·2019-11-06

    AVKARE Recalls Ranitidine Hydrochloride Capsules Due to NDMA Impurity

    AVKARE Inc. is recalling Ranitidine Hydrochloride Capsules 300 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA). The affected bottles were distributed in Colorado and Missouri.

    Product
    AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0164-2020·2019-11-06

    AvKare Recalls Ranitidine Capsules Due to NDMA Impurity

    AvKare is recalling Ranitidine Hydrochloride Capsules 150 mg because N-nitrosodimethylamine (NDMA) was found in the active ingredient.

    Product
    AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    2 states
  • SevereUSDA FSIS·106-2019·2019-11-04

    Cay Thi Queentrees Recalls Poultry Products Imported Without Inspection

    Cay Thi Queentrees Food USA is recalling approximately 43,848 pounds of slow-cooked black chicken products imported from Vietnam without FSIS inspection.

    Product
    Cay Thi Queentrees Food USA Recalls Poultry Products Produced Without Benefit of Import Inspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·19V783000·2019-10-31

    Gulf Stream Recalls 2020 Trailers Due to Gas Refrigerator Seal Defect

    Gulf Stream is recalling 2020 Amerilite, Conquest, Innsbruck, Grand River, Kingsport, and Trail Master trailers because the gas refrigerator may not be properly sealed, potentially releasing carbon monoxide or flammable LP gases.

    Product
    GULF STREAM — GULF STREAM TRAILMASTER, AMERILITE, INNSBRUCK, KINGSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V781000·2019-10-31

    Mazda Recalls Vehicles Due to Front Passenger Air Bag Inflator Defect

    Mazda is recalling specific 2003-2008 models because front passenger air bag inflators may explode, posing a risk of serious injury or death.

    Product
    MAZDA — MAZDA MAZDA6, MPV, RX-8, MAZDASPEED6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V784000·2019-10-31

    Honda Recalls Pilot and Passport for Incomplete Body Welding

    Honda is recalling 2019-2020 Pilot and 2019 Passport vehicles because front frame members may not be fully welded, potentially reducing crash protection.

    Product
    HONDA — HONDA PILOT, PASSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0094-2020·2019-10-30

    Coborn's Recalls Chicken Salad Sandwiches for Listeria Risk

    Coborn's, Inc. is recalling Chicken Salad on Marble Rye sandwiches due to the potential for Listeria monocytogenes contamination.

    Product
    Chicken Salad on Marble Rye, UPC 2 05118-XXXXX. Keep Refrigerated.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0147-2020·2019-10-30

    Nephron Recalls Fentanyl and Bupivacaine Injection Due to Glass Contamination

    Nephron Pharmaceuticals is recalling 1,855 bags of Fentanyl Citrate and Bupivacaine HCl injection due to potential glass contamination.

    Product
    PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0525-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0185-2020·2019-10-30

    Life Technologies Recalls Torrent Suite Dx Software for Incorrect Results

    Life Technologies is recalling Torrent Suite Dx software because it may incorrectly display positive results for specific clinical variants.

    Product
    Torrent Suite Dx Software Version (IUO) 5.2 Catalog Number: A29225 OEM Customer Software: Sentosa SQ Suite Software v5.6.9
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Devices)·Z-0187-2020·2019-10-30

    Torrent Suite Dx Software Recalled for Incorrect Positive Variant Results

    Life Technologies is recalling Torrent Suite Dx software because it may incorrectly display positive results for clinical variants.

    Product
    Torrent Suite Dx Software Version 5.6.4 Catalog Number:A33178 OEM Customer software: Sentosa SQ Suite Software v5.6.20 UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178
    Category
    Medical Device
    Distribution
    17 states
  • SevereFDA (Drugs)·D-0149-2020·2019-10-30

    Nephron Recalls Fentanyl and Ropivacaine Injection Due to Glass Contamination

    Nephron Pharmaceuticals is recalling 615 bags of Fentanyl and Ropivacaine Injection due to potential glass contamination from GMP deviations.

    Product
    PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-526-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0072-2020·2019-10-30

    Euphoria Fancy Food Recalls Capitan K Salmon Due to Listeria Risk

    Euphoria Fancy Food Inc. is recalling Capitan K Salmon slightly salted pieces due to potential Listeria monocytogenes contamination. The product was distributed in New York, Pennsylvania, New Jersey, and Washington.

    Product
    Capitan K Salmon slightly salted piece - net.wt 1.05 oz (200g) Distributed by: Euphoria Fancy Food Inc. 149-151 2nd avenue Brooklyn, New York 11215, USA Product of Russia UPC: 607059000362
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0095-2020·2019-10-30

    Coborn's Recalls Chicken Salad Croissant Sandwiches Due to Listeria Risk

    Coborn's is recalling Chicken Salad Croissant Sandwiches because they may be contaminated with Listeria monocytogenes. The products were distributed in Minnesota, North Dakota, South Dakota, and Wisconsin.

    Product
    Chicken Salad Croissant Sandwich, UPC 2 07275-XXXXX. Keep Refrigerated.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0152-2020·2019-10-30

    Avella Recalls Povidone Iodine Ophthalmic Solution Due to Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 808 droptainers of Povidone Iodine, 5% Ophthalmic Solution due to a lack of sterility assurance.

    Product
    Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ 85085. NDC 42852-006-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0068-2020·2019-10-30

    Veritable Vegetable Recalls Jayleaf Fresh Baby Spinach Due to E. coli Risk

    Veritable Vegetable is recalling Jayleaf Fresh Baby Spinach after customer reports of presumptive positive results for Shiga Toxin-Producing E. coli.

    Product
    Jayleaf Fresh Baby Spinach; 4 lb. box (1 x 4 lb. bag) and 12 lb. crate (3 x 4 lb. bags); Refrigerate
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0150-2020·2019-10-30

    Nephron Amino Acid Injection Recalled for Sterility and Leak Concerns

    Nephron Pharmaceuticals is recalling 162 bags of Amino Acid Injection due to lack of sterility assurance and potential leaks.

    Product
    Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10
    Category
    Drug
    Distribution
    Distributed nationwide