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.

11476–11500 of 27206

  • SevereFDA (Food)·F-1233-2024·2024-05-15

    Belgian Yummies Salted Caramel Ice Cream Cookie Sandwiches recalled for undeclared allergens

    Belgian Yummies is recalling Salted Caramel Ice Cream Cookie Sandwiches distributed in Florida due to undeclared allergens including milk, eggs, soy, wheat, peanuts, and tree nuts. The recall affects 254 units.

    Product
    Salted Caramel Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1730-2024·2024-05-15

    Vyaire Twin Tube Sample Line Nozzle Separation Recall

    Vyaire Medical recalls Twin Tube sample line 240 cm devices (Model V-707327) due to potential nozzle separation during patient use. All lots manufactured prior to June 2023 are potentially affected.

    Product
    Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTube sample line 240cm is connected to the adapter for DVT. Twin Tube Probenschlauch (707004), which is sold outside the US only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1232-2024·2024-05-15

    Raspberry Ice Cream Cookie Sandwich Recalled for Undeclared Allergens

    Belgian Yummies is recalling Raspberry Ice Cream Cookie Sandwiches distributed in Florida due to undeclared allergens including milk, eggs, wheat, peanuts, and tree nuts. Consumers with allergies should not consume these products.

    Product
    Raspberry Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0486-2024·2024-05-15

    Sapropterin Dihydrochloride Powder for Oral Solution Recalled Due to Sub-Potency

    Dr. Reddy's Laboratories is recalling 2,402 cartons of Sapropterin Dihydrochloride Powder 100mg due to sub-potency associated with powder discoloration. The affected lot (T2200352) was distributed nationwide.

    Product
    Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1235-2024·2024-05-15

    Peanut Butter Ice Cream Cookie Sandwich Recalled: Undeclared Allergens

    Belgian Yummies is recalling Peanut Butter Ice Cream Cookie Sandwiches distributed in Florida due to undeclared milk, eggs, wheat, peanuts, and tree nuts. Consumers with allergies should not consume the product.

    Product
    Peanut Butter Ice Cream Cookie Sandwich. Sandwiches packaged in a gold or clear bags. 50 sandwiches per case and weighting 4oz each sandwich.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1776-2024·2024-05-15

    Stealth S8 neurosurgical navigation software display error affecting surgical guidance

    Medtronic's Stealth S8 surgical navigation software has a display bug that may omit digits, letters, or decimals from critical readings during brain surgery. FDA classified this as Class I due to serious potential surgical errors.

    Product
    Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structures in either open or percutaneous neurosurgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1224-2024·2024-05-15

    D-LO's Pistachio Cheesecake Recalled for Undeclared Allergens and Food Coloring

    D-LO's Delightful Gourmet Cheesecake in pistachio flavor is being recalled due to undeclared wheat and soy allergens and undeclared food colors. The product poses a health risk to consumers with allergies to these ingredients.

    Product
    D-LO's Delightful Gourmet Cheesecake, Pistachio, 142g single serve UPC 8 60007 40398 9, and 678g six serving UPC 8 60007 40395 8, both serving sizes in clear plastic container with hinged lid
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1733-2024·2024-05-15

    Hologic BioZorb Bioabsorbable Markers Recalled for Adverse Events

    Hologic is recalling BioZorb Marker bioabsorbable surgical markers due to reported adverse events including infection, pain, device migration, and erosion. FDA classified this as Class I, affecting 53,492 units nationwide.

    Product
    BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4) F0231 BioZorb Marker 1cm x 3cm x 2cm 5) F0221 BioZorb Mark
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1236-2024·2024-05-15

    Belgian Yummies ice cream recalled for undeclared milk and wheat

    Belgian Yummies Homemade Ice Cream Horchata Gelato distributed in Florida is recalled due to undeclared milk and wheat allergens that may affect consumers with allergies.

    Product
    Belgian Yummies Homemade Ice Cream Horchata Gelato. Packaged in 4.75 Liter gray pan.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0485-2024·2024-05-15

    Prescription Drug Javygtor Recalled for Sub-Potency and Powder Discoloration

    Dr. Reddy's Laboratories is recalling Javygtor powder packets nationwide due to powder discoloration and sub-potency. The recall affects 17,332 cartons with multiple lot numbers.

    Product
    JAVYGTOR — JAVYGTOR (SAPROPTERIN DIHYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1609-2024·2024-05-15

    Insulin pump app may crash and drain battery, risking insulin delivery interruption

    Tandem's t:connect app version 2.7+ may crash repeatedly, draining the insulin pump battery faster than expected and potentially interrupting insulin delivery.

    Product
    t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1768-2024·2024-05-15

    Hemodialysis vascular access kit recalled due to metal shavings risk

    DURAMAX hemodialysis vascular access kits are recalled due to potential metal shavings that could enter the bloodstream and require surgical removal. Thirty units distributed in Virginia are affected.

    Product
    DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028041
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1765-2024·2024-05-15

    Vascular Access Catheter Recall Due to Metal Shaving Risk

    Angiodynamics is recalling 65 DURAFLOW 2 vascular access devices distributed in Virginia due to potential loose metal shavings that could enter the bloodstream and require surgical removal.

    Product
    DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012195
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1767-2024·2024-05-15

    FDA Recalls Vascular Access Device Due to Loose Metal Shavings Risk

    Angiodynamics' DURAMAX STACKED TIP vascular access device may contain loosely affixed metal shavings that could cause blood vessel blockage, potentially requiring surgical removal.

    Product
    DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028035
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0488-2024·2024-05-15

    Timolol Maleate ophthalmic solution recalled for defective container cap nozzle

    FDC Limited is recalling Timolol Maleate Ophthalmic Solution 0.5% distributed in New Jersey due to defective bottle caps with yellow spikes that can lodge in the nozzle, posing a risk of eye injury.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-1761-2024·2024-05-15

    Vascular access device recalled due to loose metal shavings

    DURAFLOW 2 vascular access kits for hemodialysis are being recalled because some units may contain loosely affixed metal shavings that could travel through blood vessels and potentially require surgical removal.

    Product
    DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012021
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1771-2024·2024-05-15

    DURAMAX vascular catheter recalled for possible metal shaving hazard

    The DURAMAX STACKED TIP vascular catheter may contain loosely affixed metal shavings that could embolize and require surgical removal. Lot 5807208 affected, 15 units.

    Product
    DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028191
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1219-2024·2024-05-15

    FDA Recalls Sacramento Cookie Factory Wine Wafers for Undeclared Milk Allergen

    Sacramento Cookie Factory recalls Original Wine Wafer - Lemon Vanilla cookies in multiple states due to undeclared milk allergen. Consumers with milk allergies should not consume this product.

    Product
    Original Wine Wafer - Lemon Vanilla [Two sizes: retail package of 8 wafers (7 oz) and retail gift package of 2 wafers (2 oz)]
    Category
    Food
    Distribution
    14 states
  • HighFDA (Devices)·Z-1778-2024·2024-05-15

    GE Innova IGS Fluoroscopic X-Ray Systems Adhesive Defect Recall

    GE Healthcare is recalling certain Innova IGS x-ray systems due to potential adhesive defects on component bolts. Missing adhesive could cause the detector or x-ray tube to fall during use.

    Product
    GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0489-2024·2024-05-15

    TraMADol HCl 50 mg Tablets Recalled for Foreign Baclofen Tablets

    RemedyRepack Inc. is recalling TraMADol HCl 50 mg tablets nationwide after a pharmacist discovered a baclofen tablet in a tramadol bottle. Taking the wrong medication poses serious health risks.

    Product
    TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0493-2024·2024-05-15

    Prescription antifungal injection product recalled for out-of-specification assay

    Sun Pharmaceutical is recalling Amphotericin B for Injection (50 mg vials) due to out-of-specification assay results. The recall affects 11,016 vials with lot numbers BAE0055A, BAE0056A, and BAE0068A distributed nationwide.

    Product
    AMPHOTERICIN B — AMPHOTERICIN B (AMPHOTERICIN B)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1780-2024·2024-05-15

    GE Healthcare Allia IGS 7 X-ray Systems Adhesive Bolt Failure Recall

    GE Healthcare is recalling Allia IGS 7 interventional x-ray systems due to potential adhesive failure on bolts securing the detector and x-ray tube, which could fall during use.

    Product
    GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1775-2024·2024-05-15

    Baxter Spectrum IQ Infusion Pump recalled due to improper pre-release testing

    Baxter Healthcare is recalling one Spectrum IQ Infusion Pump that underwent improper testing before release. The device was distributed nationwide including in Massachusetts.

    Product
    Baxter Spectrum IQ Infusion Pump, Product Code 3570009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1226-2024·2024-05-15

    DB Yummers Barbeque Sauce Recalled for Unapproved Processing Procedure

    Detty Family Barbeque LTD is recalling DB Yummers Mildly Spicy Barbeque Sauce because it was manufactured without FDA-approved processing procedures. About 7,080 bottles were distributed in Kentucky and Ohio.

    Product
    DB Yummers Mildly Spicy Barbeque Sauce packaged in 19.5 glass bottles, 12 bottles per case, UPC 7487200102.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1782-2024·2024-05-15

    GE Healthcare X-ray Systems: Potential Adhesive Failure Poses Fall Hazard

    GE Healthcare is recalling certain Allia and Discovery IGS x-ray systems due to potential adhesive failure that could cause the detector, elevator, or x-ray tube to fall. No injuries reported.

    Product
    GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
    Category
    Medical Device
    Distribution
    Distributed nationwide