The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

12451–12475 of 27206

  • HighFDA (Devices)·Z-1201-2024·2024-03-06

    Integra Cranial Access Kit Recalled for Compromised Sterile Packaging

    Integra LifeSciences is recalling 8,906 units of the Cranial Access Kit because the sterile packaging failed integrity testing, potentially compromising sterility. Units were distributed worldwide.

    Product
    Ref No: INSHITH / 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-0977-2024·2024-03-06

    Quaker Chewy Granola Bars recalled for potential Salmonella

    The Quaker Oats Co. is recalling Quaker Chewy Granola Bars (Fruity Fun variety) due to potential Salmonella contamination. Affected products were distributed nationally and internationally.

    Product
    Quaker Chewy Granola Barsn(Fruity Fun) Amazing Apple and Splendid Strawberry Variety Pack 0.84 oz 48 Count
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0959-2024·2024-03-06

    Quaker Chewy Mini Dipps Summer Night S'mores bars recalled due to Salmonella risk

    The Quaker Oats Co. is voluntarily recalling Quaker Chewy Mini Dipps Summer Night S'mores bars due to potential Salmonella contamination. The recall affects products with Best Before dates of Aug-02-24 and earlier distributed nationally.

    Product
    Quaker Chewy Mini Dipps Summer Night S'mores 12ct 8.9 oz Bars are individually wrapped in plastic and then packaged in paperboard boxes.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1098-2024·2024-03-06

    MEDLINE Medical Device Kits Recalled for Potential Sterility Issues

    Medline Industries recalls multiple medical device kits and trays manufactured with components that may lack sterility. The affected solutions could be non-sterile, posing a potential safety risk.

    Product
    MEDLINE Kits, trays, and packs labeled as follows: a) Description, REF DYNDH1679; b) BREAST BIOPSY TRAY, REF DYNDH1664; c) BREAST BIOPSY TRAY, REF DYNDH1431A; d) BREAST BIOPSY TRAY, REF DYNJ46448; e) BREAST BIOPSY TRAY, REF DYKE1520B; f) COLON KIT- BERLIN, REF DYNDH1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1212-2024·2024-03-06

    Olympus colonoscope PCF-H190TL recalled for missing protective adhesive

    Olympus has recalled certain repaired colonoscope models lacking protective adhesive that could fail under vibration, temperature, or severe shock loads. Affected models include the PCF-H190TL, distributed nationwide.

    Product
    Colonoscope, Model Number PCF-H190TL.
    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-0975-2024·2024-03-06

    Quaker Chewy Granola Bars Recalled for Potential Salmonella Contamination

    Quaker Oats is recalling Quaker Chewy Granola Bars (Fruity Fun) Amazing Apple due to potential Salmonella contamination. Affected products with Best Before dates of Aug-02-24 or earlier were distributed nationally and internationally.

    Product
    Quaker Chewy Granola Bars (Fruity Fun) Amazing Apple 0.84 oz 6 Count
    Category
    Food
    Distribution
    0 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
    0 states
  • HighFDA (Devices)·Z-1217-2024·2024-03-06

    Orthopedic knee implant recall due to potential stem misalignment

    United Orthopedic Corporation recalls USTAR II knee implants due to potential incorrect orientation of the curved stem. Affected products were distributed across multiple US states and internationally.

    Product
    USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 - 11X125, PE25151113 - 13X125mm, PE25151115 - 15X125mm, PE25151117 - 17X125mm, PE25151119 - 19X125mm, PE25151209 - 9X150mm, PE25151211 - 11
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1183-2024·2024-03-06

    Infusion Pumps Model Z-800WF Recalled Due to Alarm Volume Malfunction

    Zyno Medical recalls Z800 infusion pumps (Model Z-800WF) with software version 5.2.05 due to a potential alarm volume malfunction. The alarm may revert to low volume, delaying therapy and risking organ failure in extreme cases.

    Product
    Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0938-2024·2024-03-06

    Food Recall: Quaker Big Chewy Bars Potential Salmonella Contamination

    The Quaker Oats Co. has recalled Quaker Big Chewy Bars Variety Pack 36ct due to potential Salmonella contamination. The product was distributed nationally and in U.S. territories.

    Product
    Quaker Big Chewy Bars Variety Pack 36ct 53.3 oz Bars are individually wrapped in plastic and packaged in paperboard boxes.
    Category
    Food
    Distribution
    0 states
  • 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 (Food)·F-0933-2024·2024-03-06

    MUTTI Crushed Tomatoes Recall Due to Can Lining Detachment

    Mutti USA is recalling MUTTI Crushed Tomatoes because the internal can lining may be detaching into the product. The recall affects 137,634 units distributed to 24 states.

    Product
    MUTTI Crushed Tomatoes; Polpa; Net Wt 27.9 OZ (1lb 11.9 OZ) 790g; UPC 85469300071
    Category
    Food
    Distribution
    25 states
  • HighFDA (Food)·F-0986-2024·2024-03-06

    Quaker granola cereal recalled nationwide for potential Salmonella contamination

    Quaker Chewy Granola Breakfast Cereal in chocolate flavor is recalled due to potential Salmonella contamination. Affected products have a 'Best Before' date of Aug-02-24 or earlier and were distributed nationally and internationally.

    Product
    Quaker Chewy Granola Breakfast Cereal Chocolate 12.6 oz; 12.6 oz 2 Pack
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0955-2024·2024-03-06

    Quaker Chewy Dipps Chocolate Chip bars recalled for potential Salmonella

    Quaker Chewy Dipps Chocolate Chip bars are being recalled nationwide due to potential Salmonella contamination. Affected products have a Best Before date of Aug-02-24 or earlier.

    Product
    Quaker Chewy Dipps Chocolate Chip 6ct 6.5 oz; 14ct 15.3 oz; 24ct 26.2 oz; 30ct 32.7 oz; 34ct 37.1 oz. Bars are individually wrapped in plastic and then packaged in paperboard boxes or totes.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0982-2024·2024-03-06

    Cereal Treat Bars Recalled Due to Potential Salmonella Contamination

    The Quaker Oats Co. is recalling Cap'n Crunch Treats Bars Variety Pack due to potential Salmonella contamination. Products with a Best Before date of August 2, 2024 or earlier are affected.

    Product
    Cap'n Crunch Treats Bars Variety Pack 0.84 oz 32 Count;
    Category
    Food
    Distribution
    0 states
  • 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 (Devices)·Z-1121-2024·2024-03-06

    Medline Nursing Education Kits Recalled for Potential Lack of Sterility

    Medline Industries recalls 844 units of nursing education kits and trays due to potential lack of sterility in Nurse Assist irrigation solution components. Products distributed nationwide and internationally.

    Product
    Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B; b) NUR 213, REF EDUC05054B; c) NURSING SKILLS, REF EDUC05050B; d) NURSING SUPPLY BAG, REF EDUC1024
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
    0 states
  • HighFDA (Food)·F-0976-2024·2024-03-06

    Quaker Chewy Granola Bars recalled for potential Salmonella contamination

    The Quaker Oats Company has recalled Quaker Chewy Granola Bar (Fruity Fun, Splendid Strawberry) 0.84 oz packages due to potential Salmonella contamination. Approximately 22.5 million cases were distributed nationally and internationally.

    Product
    Quaker Chewy Granola Bar (Fruity Fun) Splendid Strawberry 0.84 oz 6 Count
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1197-2024·2024-03-06

    Integra Cranial Access Kit Recalled Due to Packaging Integrity Defect

    Integra LifeSciences is recalling 188 units of the Integra Cranial Access Kit because defective sterile packaging may have compromised product sterility.

    Product
    Ref No: INS7250 / 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-1218-2024·2024-03-06

    Bone plates and surgical screws distributed without FDA pre-market clearance

    Acumed LLC is recalling 2,952,121 units of Acu-Loc bone plates, screws, and accessories distributed worldwide because they were placed on the market without FDA pre-market clearance. The safety and effectiveness of these devices have not been verified by the FDA.

    Product
    Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plate Standard, Left; 70-0046 Acu-Loc VDU Plate Standard, Right; 70-0046-S Acu-Loc VDU Plate Standard, Right; 70-0047 Acu-Loc VDU Plate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0965-2024·2024-03-06

    Quaker Chocolatey Favorites Snack Mix recalled for potential Salmonella

    The Quaker Oats Co. is recalling Quaker Chocolatey Favorites Snack Mix (Best Before Aug-02-24 and earlier) due to potential Salmonella contamination. The product was distributed nationally across all US states, Puerto Rico, Guam, Saipan, and internationally.

    Product
    Quaker Chocolatey Favorites Snack Mix; 20ct Box 378 oz
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0355-2024·2024-03-06

    Omeprazole and Sodium Bicarbonate Prescription Drug Recalled Due to Subpotency

    Bausch Health Companies is recalling 3,600 cartons of Omeprazole and Sodium Bicarbonate nationwide. The drug was found to be subpotent, containing less active ingredient than specified.

    Product
    OMEPRAZOLE AND SODIUM BICARBONATE — OMEPRAZOLE AND SODIUM BICARBONATE (OMEPRAZOLE, SODIUM BICARBONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0931-2024·2024-03-06

    Chin Jung White Kimchi Recalled Due to Undeclared Fish Allergen

    Chin Jung White Kimchi is being recalled because it contains undeclared fish, a common allergen. Consumers with fish allergies should not consume this product.

    Product
    Chin Jung White Kimchi - 3 lb. 8 oz (1.58 kg) plastic jars
    Category
    Food
    Distribution
    0 states