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.

11501–11525 of 27206

  • 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-1220-2024·2024-05-15

    Martinelli's Gold Medal Apple Juice Recalled for Elevated Inorganic Arsenic

    S Martinelli & Company is recalling Martinelli's Gold Medal Apple Juice (1 Liter) due to elevated levels of inorganic arsenic. The affected product has Best By dates of March 9, 2026 or March 10, 2026.

    Product
    Martinelli's Gold Medal Apple Juice From U.S. Grown Fresh Apples 1 Liter (33.8 fl oz.) No Additives of Any Kind UPC 0 00 41244 00102 6
    Category
    Food
    Distribution
    35 states
  • 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 (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 (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 (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 (Devices)·Z-1759-2024·2024-05-15

    Randox Clinical Chemistry Calibration Serum Recalled for Measurement Bias

    Randox Laboratories has recalled Clinical Chemistry Calibration Serum (Cal2351/Cal10388) due to negative bias in inorganic phosphate measurements on RX Series instruments. The issue could affect the accuracy of clinical chemistry test results.

    Product
    Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemistry tests.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1774-2024·2024-05-15

    Vascular access device recalls due to metal shaving contamination risk

    Angiodynamics is recalling the BioFlo DuraMax 15.5F Single Valve Sheath VascPak Kit due to possible loose metal shavings. Metal shavings could enter the bloodstream and require surgical removal.

    Product
    BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H965103038181
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1758-2024·2024-05-15

    Spinal Fusion Device Recall: Setscrew Insertion and Tightening Issues

    SPINEART's PERLA TL 25D spinal fusion screws are being recalled due to difficulties with setscrew insertion inside the screw head. The setscrew may not be properly tightened or may be positioned incorrectly, potentially affecting spinal stability.

    Product
    PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS 55 35-S TLF-DS 55 40-S TLF-DS 55 45-S TLF-DS 65 35-S TLF-DS 65 40-S TLF-DS 65 45-S TLF-DS 65 50-S The PERLA¿ TL system is intended to provide
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1228-2024·2024-05-15

    Ice Cream Strawberry Gelato Recalled for Undeclared Yellow #5 Allergen

    Belgian Yummies is recalling 53 units of 5-liter strawberry gelato distributed in Florida due to undeclared Yellow #5 (Tartrazine) allergen. Consumers with Yellow #5 sensitivity should not consume this product.

    Product
    Belgian Yummies Homemade Ice Cream Strawberry Gelato. Packaged in 5 Liter gray carapina liner.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1227-2024·2024-05-15

    DB Yummers Island Marinade BBQ Sauce Recalled for Unapproved Processing

    Detty Family Barbeque LTD is recalling DB Yummers Island Marinade Barbeque Sauce because it was not manufactured using an FDA-approved thermal processing procedure, creating potential for pathogenic contamination.

    Product
    DB Yummers Island Marinade Barbeque Sauce packaged in 19.5 glass bottles, 12 bottles per case, UPC 7487200103.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1762-2024·2024-05-15

    Hemodialysis Vascular Access Kit Recalled for Loose Metal Shavings

    Angiodynamics DURAFLOW 2 hemodialysis kits may contain loosely affixed metal shavings that could enter the bloodstream. Metal fragments may require surgical removal if they embolize.

    Product
    DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012035
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0484-2024·2024-05-15

    Prescription Duloxetine 60 mg capsules recalled for N-nitroso impurity

    Breckenridge Pharmaceutical is recalling Duloxetine 60 mg capsules due to elevated levels of N-nitroso-duloxetine, a manufacturing impurity above FDA limits. No illnesses have been reported.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1783-2024·2024-05-15

    GE Healthcare Allia IGS Fluoroscopic Systems Recall: Missing Adhesive

    GE Healthcare recalls Allia IGS and related interventional fluoroscopic x-ray systems due to potentially missing adhesive on bolts. The defect could allow the detector/elevator or x-ray tube in the gantry assembly to fall.

    Product
    GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1773-2024·2024-05-15

    Vascular catheter recalled for potential metal shavings that may cause embolization

    Angiodynamics recalled a vascular access catheter used for hemodialysis because it may contain loosely affixed metal shavings. These shavings could potentially detach and move through blood vessels, possibly requiring surgical removal.

    Product
    DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028201
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0487-2024·2024-05-15

    Tramadol Hydrochloride Tablets Recalled Due to Baclofen Contamination

    Advagen Pharma is recalling Tramadol Hydrochloride Tablets after a pharmacy discovered baclofen tablets mixed in a bottle of tramadol. This nationwide recall affects 2,592 bottles.

    Product
    TRAMADOL HYDROCHLORIDE — TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1763-2024·2024-05-15

    Duraflow 2 vascular catheter kit recalled for loose metal shavings

    Angiodynamics Inc. is recalling DURAFLOW 2 vascular catheter kits used for hemodialysis and apheresis access due to potential metal shavings that may detach and travel through the vascular system, potentially requiring surgical removal.

    Product
    DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012115
    Category
    Medical Device
    Distribution
    1 state
  • 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-0483-2024·2024-05-15

    Duloxetine delayed-release capsules recalled for manufacturing impurity exceeding limits

    Breckenridge Pharmaceutical recalls Duloxetine 20 mg capsules nationwide after detecting N-nitroso-duloxetine impurity above FDA-recommended limits in approximately 7,188 units from lot 220456, expiring February 2025.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1229-2024·2024-05-15

    Belgian Yummies Ice Cream Gelato Recalled for Undeclared Yellow #5 Allergen

    Belgian Yummies Homemade Ice Cream Birthday Cake Gelato is being recalled because it contains undeclared Yellow #5, an allergen not listed on the label. The recall affects products distributed in Florida.

    Product
    Belgian Yummies Homemade Ice Cream Birthday Cake Gelato. Packaged in 5 Liter gray carapina liner.
    Category
    Food
    Distribution
    0 states
  • 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 (Food)·F-1218-2024·2024-05-15

    Sacramento Cookie Factory Recalls Wine Wafers for Undeclared Milk Allergen

    Sacramento Cookie Factory is recalling California Wine Wafer - Mocha Chocolate products because they contain undeclared milk, a common allergen. The recall affects retail packages distributed across multiple U.S. states.

    Product
    California Wine Wafer - Mocha Chocolate and Original Wine Wafer - Mocha Chocolate [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-1764-2024·2024-05-15

    DURAFLOW 2 Vascular Access Device Recalled for Loose Metal Shavings

    Angiodynamics is recalling DURAFLOW 2 vascular access devices due to loose metal shavings that may travel through blood vessels, potentially requiring surgical removal.

    Product
    DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012185
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1769-2024·2024-05-15

    Angiodynamics Duramax Vascular Access Kit Recall Due to Metal Shavings

    Angiodynamics recalls the Duramax Stacked Tip vascular access kit used for hemodialysis due to potential loose metal shavings that could enter the bloodstream and require surgical removal.

    Product
    DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028045
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1223-2024·2024-05-15

    Goya Red Kidney Beans Recalled for Swollen and Leaking Cans

    Tradewind Foods de Puerto Rico Inc. is recalling Goya Red Kidney Beans due to swollen and leaking cans discovered during an FDA inspection. The affected product was distributed in Puerto Rico and St. Croix.

    Product
    Goya Red Kidney Beans, Net Wt.15.5oz.(439g), metal (tin) cans, 24 cans/15.5 oz. per case
    Category
    Food
    Distribution
    0 states