The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

9751–9775 of 53039

  • HighFDA (Devices)·Z-1196-2024·2024-03-06

    Integra cranial access kit recalled for sterile packaging failure

    Integra LifeSciences is recalling 1,324 cranial access kits due to sterile packaging defects that may compromise product sterility.

    Product
    Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0991-2024·2024-03-06

    Breakfast Cereal Recall: Quaker Oatmeal Squares for Potential Salmonella

    The Quaker Oats Co. is recalling Quaker Oatmeal Squares Breakfast Cereal due to potential Salmonella contamination. The product was distributed nationally and internationally.

    Product
    Quaker Oatmeal Squares Breakfast Cereal, Variety Pack 43.5 oz 3 Pack
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0354-2024·2024-03-06

    FDA recalls Lubricant PM Ointment due to sterility assurance failure

    Lubricant PM Ointment is being recalled by AACE Pharmaceuticals due to the manufacturer's failure to assure the product was manufactured under sterile conditions.

    Product
    Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE Pharmaceuticals, Inc., Fairfield, NJ 07004, NDC 71406-124-35, UPC 371406124356
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0958-2024·2024-03-06

    Quaker Chewy Mini Dipps Birthday Blast bars recalled for potential Salmonella

    Quaker Oats is voluntarily recalling Quaker Chewy Mini Dipps Birthday Blast bars for potential Salmonella. The recall covers products with Best Before dates of Aug 2, 2024 and earlier distributed nationally.

    Product
    Quaker Chewy Mini Dipps Birthday Blast 12ct 8.9 oz Bars are individually wrapped in plastic and then packaged in paperboard boxes.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0962-2024·2024-03-06

    Quaker Simply Granola Oats Cereal Recalled for Potential Salmonella

    Quaker Simply Granola Oats, Honey & Almonds Cereal with Best Before dates of Aug-02-24 or earlier is being recalled due to potential Salmonella contamination. The voluntary recall affects 22,512,942 cases distributed nationwide.

    Product
    Quaker Simply Granola Oats, Honey & Almonds Cereal; 2PK 48.2 oz; 24.1 oz.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0932-2024·2024-03-06

    Chin Jung White Kimchi Recalled Due to Undeclared Fish Allergen

    Chin Jung White Kimchi jars recalled due to undeclared fish allergen. Products distributed to supermarkets in California, Colorado, and Nevada may pose risk to consumers with fish allergies.

    Product
    Chin Jung White Kimchi - 7 lb. 8 oz.(3.4 kg) plastic jars
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0363-2024·2024-03-06

    Lidocaine and Phenylephrine Injectable Vials Recalled for Glass Delamination

    Denver Solutions is recalling Lidocaine-Phenylephrine injectable vials nationwide due to glass delamination in the vials. The defect could potentially introduce glass fragments into the medication.

    Product
    Lidocaine HCL 1% (10mg/mL), PHENYLephrine HCL 1.5% (15mg/mL), 1 ml in a Single- Dose Vial, RX Only, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-090-42
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1199-2024·2024-03-06

    Integra Cranial Access Kit recall over sterile packaging defect

    Integra LifeSciences is recalling the Cranial Access Kit due to a defect in the sterile packaging that may compromise product sterility. Affects 30 units distributed worldwide.

    Product
    Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0996-2024·2024-03-06

    Instant oatmeal products recalled due to potential Salmonella contamination

    The Quaker Oats Company is recalling Cap n Crunch Instant Oatmeal products due to potential Salmonella contamination. The recall affects products distributed nationwide and internationally.

    Product
    Cap n Crunch Instant Oatmeal 8.5 oz 6 Count ; Cap n Crunch OOPS! All Berries Instant Oatmeal8.5 oz 6 Count ; Cap n Crunch Instant Oatmeal Variety Pack 32.1 oz 24 Count
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1202-2024·2024-03-06

    Integra Cranial Access Kit Recalled for Defective Sterile Packaging

    Integra LifeSciences is recalling 915 units of its Cranial Access Kit worldwide due to defective sterile packaging that may compromise product sterility. The header bags failed required packaging integrity testing.

    Product
    Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0350-2024·2024-03-06

    Mesalamine extended-release capsules recalled due to dissolution failure

    Sun Pharmaceutical is recalling Mesalamine extended-release capsules due to failed dissolution specifications. The affected capsules may not dissolve and release medication properly.

    Product
    MESALAMINE — MESALAMINE (MESALAMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0359-2024·2024-03-06

    7 Eleven Hand Sanitizer Gel recalled for manufacturing facility deficiencies

    Seatex LLC is recalling 1,282 cases of 7 Eleven Hand Sanitizer Gel due to manufacturing facility deficiencies found during FDA inspection. The product was distributed nationwide.

    Product
    7 Eleven Hand Sanitizer Gel, Ethanol 70% v/v Antiseptic, Mountain Spring Scent, 1250 mL cases, Magnus 16005 Gateway Drive, Ste 300, Frisco, TX 75033
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0353-2024·2024-03-06

    CVS Health Lubricant Eye Ointment recalled due to lack of sterility assurance

    CVS Health Lubricant Eye Ointment is being recalled nationwide due to lack of sterility assurance during manufacturing. The recall affects 159,334 units distributed in 3.5-gram tubes with lot numbers A2F03, A2I02, A2L02, A3C04, and A3H04.

    Product
    CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 gram tubes, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 76168-707-35, UPC 050428634141
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0992-2024·2024-03-06

    Cereal Recall: Cap n Crunch OOPS! All Berries Due to Salmonella Risk

    The Quaker Oats Co. is recalling Cap n Crunch OOPS! All Berries Cereal (10.3 oz) due to potential Salmonella contamination. Products with a Best Before date of Aug-02-24 or earlier are affected nationally.

    Product
    Cap n Crunch OOPS! All Berries Cereal 10.3 oz
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1198-2024·2024-03-06

    Integra Cranial Access Kit recalls due to packaging sterility defect

    Integra LifeSciences is recalling 161 units of the Cranial Access Kit (Lot 7124720) due to packaging defects that may compromise sterility. The recall affects units distributed worldwide.

    Product
    Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1193-2024·2024-03-06

    Cranial Access Kit recalled due to sterile packaging integrity defect

    Integra LifeSciences is recalling a Cranial Access Kit due to packaging defects that may compromise sterility. The product was distributed worldwide.

    Product
    Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0934-2024·2024-03-06

    Frozen Pizza Recalled for Undeclared Milk Allergen in Plant-Based Product

    Oggi Plant-Based Americana frozen pizza contains undeclared milk, posing a risk to consumers with milk allergies. The recall affects 5,040 units distributed in California, Illinois, and Washington.

    Product
    Oggi Pizza Plant Based Americana Beyond Meat Crumbles on Cauliflower Crust, gluten-free frozen pizza - cook before serving, net wt. 13.76oz (390g). One pizza wrapped in plastic film in a cardboard box. Retail box UPC 6 28451 68487 9. There are 12 pizza per case, and each case h
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0950-2024·2024-03-06

    Quaker Chewy Bars Less Sugar Peanut Butter recalled for potential Salmonella

    The Quaker Oats Co. is recalling Quaker Chewy Bars Less Sugar Peanut Butter Chocolate Chip due to potential Salmonella contamination. The product was distributed nationally and in several U.S. territories.

    Product
    Quaker Chewy Bars Less Sugar Peanut Butter Chocolate Chip 8ct 6.7 oz. Bars are individually wrapped in plastic and then packaged in paperboard boxes.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0963-2024·2024-03-06

    Quaker Simply Granola Cereal Recalled for Potential Salmonella

    The Quaker Oats Co. is recalling Quaker Simply Granola Oats, Honey, Raisins & Almonds Cereal due to potential Salmonella. Affected products have Best Before dates of August 2, 2024, or earlier and were distributed nationally and internationally.

    Product
    Quaker Simply Granola Oats, Honey, Raisins & Almonds Cereal; 2PK 48.2 oz; 24.1 oz; 69 oz.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0997-2024·2024-03-06

    Food: Gatorade Protein Bars Recalled Due to Potential Salmonella

    The Quaker Oats Co. is voluntarily recalling Gatorade Protein Bar Peanut Butter Chocolate with Best Before dates of Aug-02-24 and earlier due to potential Salmonella. The product was distributed nationally and internationally.

    Product
    Gatorade Protein Bar Peanut Butter Chocolate 2.8 oz; 1 count; 6 count; 12 count
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1182-2024·2024-03-06

    IdentiTi ALIF surgical graft bolts recalled due to intraoperative breakage

    Alphatec Spine recalls IdentiTi ALIF graft bolts after reports of breakage during implantation. Approximately 12,777 devices are affected worldwide.

    Product
    IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 132-10-85-350 / IdentiTi ALIF SA Graft Bolt, 08.5 x 35 mm 132-10-90-250 / IdentiTi ALIF SA G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1200-2024·2024-03-06

    Integra Cranial Access Kit Recall Due to Sterile Packaging Defect

    Integra LifeSciences is recalling the INS7280 Cranial Access Kit due to a packaging defect that may compromise product sterility. The recall affects 82 units distributed worldwide.

    Product
    INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0361-2024·2024-03-06

    Moxifloxacin Ophthalmic Injection Solution Recalled for Glass Particle Contamination

    Denver Solutions is recalling Moxifloxacin PF eye injection vials nationwide due to glass delamination in the vials. The affected product is used for eye surgery injections.

    Product
    Moxifloxacin PF, 1mg/ml, in Sterile Balanced Salt Solution (BSS) Sterile injection, Intracameral Use Only, Single- Dose Vial, Leiters 13796 Compark Blvd, Englewood, CO 80112, NDC 71449-096-42
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0964-2024·2024-03-06

    Quaker Protein Granola recalled for potential Salmonella contamination nationwide

    The Quaker Oats Company voluntarily recalled Quaker Protein Granola Oats, Chocolate, & Almonds Flavor nationwide due to potential Salmonella contamination. Affected products have a Best Before date of August 2, 2024 or earlier.

    Product
    Quaker Protein Granola Oats, Chocolate, & Almonds Flavor: 2PK 36 oz; 18 oz
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0995-2024·2024-03-06

    Cereal Recall: Gamesa Marias Due to Potential Salmonella

    The Quaker Oats Co. is recalling Gamesa Marias Cereal due to potential Salmonella contamination. The recall affects products distributed nationwide and internationally with a Best Before date of Aug-02-24 or earlier.

    Product
    Gamesa Marias Cereal 11.4 oz and 11.4 oz 2 count
    Category
    Food
    Distribution
    2 states