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.

6901–6925 of 26961

  • HighFDA (Devices)·Z-1327-2025·2025-03-19

    Blood Pump Recalled for Potential Fluid Leakage During Clinical Use

    Spectrum Medical is recalling Quantum Perfusion blood pumps due to potential fluid leakage during priming or clinical use. The issue affects approximately 1,487 units distributed nationwide.

    Product
    Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1317-2025·2025-03-19

    ZOLL Powerheart G5 AED May Fail Self-Test After Environmental Exposure

    ZOLL Powerheart G5 AED devices may fail their self-test if exposed to extreme temperatures or humidity. Approximately 56,981 units are being recalled nationwide and internationally.

    Product
    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TSO. Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat irregularities, such as
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1326-2025·2025-03-19

    Beckman Coulter DxI 9000 Analyzer wash wheel mixer defect may prevent operation

    Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to a mechanical defect in the wash wheel mixer that may prevent the device from operating properly. The defect can cause test delays or cancellation.

    Product
    DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0618-2025·2025-03-19

    Trader Joe's Solid White Albacore Tuna Recalled for Botulism Risk

    Trader Joe's branded Solid White Albacore Tuna is being recalled because the easy-pull lids were not properly secured, potentially allowing Clostridium botulinum contamination. Approximately 14,147 cases were distributed nationwide.

    Product
    Trader Joe's branded Solid White Albacore Tuna in water, Low sodium; NET WT. 5 OZ (142g) DR WT. 4 OZ (113g); Dist & Sold Exclusively By: Trader Joe's, Monrovia, CA 91816; UPC# 95836
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0273-2025·2025-03-19

    Acne treatment gel recalled for benzene contamination nationwide

    Zapzyt Acne Treatment Gel (10% benzoyl peroxide) distributed nationwide is being recalled due to contamination with benzene. Consumers should stop using affected lots immediately.

    Product
    ZAPZYT ACNE TREATMENT GEL — ZAPZYT ACNE TREATMENT GEL (BENZOYL PEROXIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1320-2025·2025-03-19

    ZOLL Powerheart G5 AED may fail self-test in extreme temperatures or humidity

    ZOLL is recalling 73 Powerheart G5 AED units that may fail their internal self-test when exposed to extreme temperatures or humidity. Affected devices could be unreliable in emergencies.

    Product
    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, (3) G5S-10C, (4) G5S-11C; Software Version: NA Product Description: The Powerheart G5 automated external defibrillator (AED) is designed for treating life-threatening heart beat i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0624-2025·2025-03-19

    Green Chile Bean Burritos Recalled for Undeclared Milk Allergen

    Mi Ranchito Foods is recalling Green Chile Bean Burritos because milk is not listed in the ingredient statement, posing a risk for consumers with milk allergies.

    Product
    Green Chile Bean Burrito, 15 days refrigerated at 33 45 degrees Fahrenheit. 120 days frozen at or below 32 degrees Fahrenheit. Packaged in cellophane wrapper. Net wt. 10 ounces, UPC #21856 11136. Mi Ranchito Foods, Inc. 606 Central Avenue, Bayard, NM 88023
    Category
    Food
    Distribution
    0 states
  • HighFDA (Drugs)·D-0261-2025·2025-03-19

    Drug Recall: Alprostadil Affected by Manufacturing Practice Deviations

    Alprostadil 3.0 gm is being recalled due to manufacturing practice deviations. Limited distribution affects product with lot number HAALC0020922 (expiration August 2025).

    Product
    Alprostadil Container Description: Amber color bottle
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-1319-2025·2025-03-19

    ZOLL Powerheart G5 AED May Fail Self-Test in Extreme Environmental Conditions

    ZOLL is recalling certain Powerheart G5 AED models that may fail their self-test function when exposed to extreme temperature or humidity. Affected devices might not function properly in emergencies.

    Product
    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, (3) G5A-05C, (4) G5A-08C, (5) G5A-10C, (6) G5A-13C, (7) G5A-15C, (8) G5A-22C, (9) G5A-41C, (10) G5A-85C, (11) G5A-90C (12) G5A-80-L; Software Version: NA Product Description: The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1311-2025·2025-03-19

    Multiple hemostatic forceps models recalled due to clamp breakage risk

    Aesculap is recalling 1,147 hemostatic forceps due to clamp breakage risk when used beyond design specifications. Units were distributed nationwide and internationally to healthcare providers.

    Product
    Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, Glover ATR.CLAMP CVD 215MM; (2) REF FB459R, Glover ATR.CLAMP CVD 245MM; (3) REF FB461R, Glover ATR.CLAMP 195MM; (4) REF FB462R, Glover ATR.CLAMP 210MM; (5) REF FB469R, Leland-Jones Peripheral CLMPSTR 195MM;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1299-2025·2025-03-19

    GE Healthcare CT Systems May Leak Coolant Fluid on Floor

    GE Healthcare Revolution CT and Apex series systems can leak coolant fluid onto the floor near the gantry, creating a slip and fall hazard. The blue-colored fluid is non-corrosive and not hot, but poses injury risk if not noticed.

    Product
    GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1322-2025·2025-03-19

    ZOLL Powerheart G5 AED Self-Test May Fail Under Extreme Environmental Conditions

    ZOLL is recalling certain Powerheart G5 AED units that may fail their self-test when exposed to extreme temperatures or humidity. The affected devices could fail to function properly in emergencies.

    Product
    Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01A, (3) G5S-02A, (4) G5S-05A, (5) G5S-08A, (6) G5S-10A, (7) G5S-11A, (8) G5S-80A-TSO, (9) G5S-80-L (10) G5S-90A; Software Version: NA Product Description: The Powerheart G5 automa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0260-2025·2025-03-19

    Bimatoprost drug recalled for manufacturing quality deviations

    Aspen Biopharma Labs is recalling Bimatoprost due to manufacturing practice deviations. The recall is voluntary and affects product distributed to wholesalers.

    Product
    Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0258-2025·2025-03-19

    Prescription statin LIVALO tablets recalled due to foreign tablets in bottles

    Kowa Pharmaceuticals America is recalling LIVALO (pitavastatin calcium) 4 mg tablets from a specific batch due to the presence of foreign tablets or capsules mixed with the correct medication. No illnesses have been reported.

    Product
    LIVALO — LIVALO (PITAVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0265-2025·2025-03-19

    Voriconazole Antifungal Drug Recalled for Manufacturing Deviations

    Aspen Biopharma Labs is voluntarily recalling Voriconazole, an antifungal medication, due to manufacturing process deviations. The product was distributed to three distributors in Hong Kong and Florida.

    Product
    Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0623-2025·2025-03-19

    Coyote Valley Sour Cream & Onion Chips Recalled for Understated Sodium Content

    Coyote Valley Sour Cream & Onion Chips from Uncle Rays, LLC are being recalled because the product contains more sodium than the label states. Affected products were distributed to customers in Ohio, Nevada, and Texas.

    Product
    Coyote Valley Sour Cream & Onion Chips, Net Wt. 5oz, UPC 744234810775, Item # 8014265, Food Express USA, Dallas, TX 75261
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1301-2025·2025-03-19

    GE Healthcare Revolution CT systems recalled for potential coolant leaks

    GE Healthcare is recalling Revolution CT and Revolution Apex series systems due to potential coolant fluid leaks from the gantry base, which could create a slip and fall hazard.

    Product
    GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0262-2025·2025-03-19

    FDA recalls finasteride drug for manufacturing compliance deviations

    Aspen Biopharma Labs is recalling finasteride due to manufacturing compliance deviations. The 120 kg voluntary recall was distributed to three distributors in Hong Kong and Florida.

    Product
    Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0665-2025·2025-03-19

    Black beans recalled for elevated fungicide residue levels

    Black dried beans have been recalled due to elevated levels of fungicide residue. The affected product was distributed to Arizona, California, Idaho, and Oregon.

    Product
    Black Beans, Dried, net wt. 16 OZ (1 LB) 454g, packaged in plastic bag. Packaged in the U.S. UPC 0 70552 70412 1. DISTRIBUTED BY: WinCo Foods, LLC, BOISE, ID 83704
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0275-2025·2025-03-19

    Kids by Babyganics SPF 50 Sunscreen Recalled for Chemical Contamination

    Kids by babyganics SPF 50 sunscreen is being recalled due to chemical contamination. Approximately 449,502 units distributed nationwide in the U.S. and Canada are affected in this FDA Class II recall.

    Product
    Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray bottles UPC 813277019954 and UPC 813277019800; and b) Twinpack UPC 813277019930; Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0629-2025·2025-03-19

    Mi More Coco Bandera snacks recalled for undeclared color on label

    San Miguel Nuts Corp. is recalling Mi More Coco Bandera snacks because the product label fails to declare a color ingredient. The recall affects 3,026 bars distributed to New Jersey.

    Product
    Mi More snacks, Coco Bandera, 3 oz. Plastic container, 8 per container, 20 per case box
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1257-2025·2025-03-12

    Insulin pump recall: Medtronic Paradigm models malfunction during airplane flight

    Medtronic MiniMed's Paradigm insulin pumps can malfunction during airplane flight due to air pressure changes, potentially causing dangerously high or low blood sugar levels that could be fatal.

    Product
    Paradigm insulin pump, REF: MMT-754
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1244-2025·2025-03-12

    Rotarex Atherectomy Catheter Recalled for Helix Fracture Risk

    Bard is recalling Rotarex Atherectomy System catheters due to potential helix fracture or breakage that could cause vessel injury and severe bleeding. Updated instructions are being distributed to clarify procedural steps to reduce this risk.

    Product
    Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex: S 6 F x 110 cm, REF: 80236; S 6 F x 135 cm, REF: 80237; S 8 F x 85 cm, REF: 80238; S 8 F x 110 cm, REF: 80239
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0588-2025·2025-03-12

    Watermelon and Cucumber Products Recalled for Potential Salmonella Contamination

    JFE Franchising is recalling watermelon and cucumber products with Tajin seasoning due to potential Salmonella contamination. Affected packages were distributed in TX, LA, WY, and AZ with sell-by dates from October 12 through December 5, 2024.

    Product
    Mixed Melon, Cucumber & Tajin 18 oz Watermelon & Cucumber w/ Tajin 18 oz packed in clamshells
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0589-2025·2025-03-12

    Cobb Salad Products Recalled for Potential Salmonella Contamination

    JFE FRANCHISING INC is recalling Cobb Salad products (22 oz and 11 oz packages) due to potential Salmonella contamination. Products were distributed in Texas, Louisiana, Wyoming, and Arizona.

    Product
    Family Cobb Salad 22 oz Cobb Salad 11 oz packed in clamshells
    Category
    Food
    Distribution
    4 states