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.

11526–11550 of 22152

  • HighFDA (Devices)·Z-1770-2024·2024-05-15

    Vascular access device recalled for potential metal shavings embolism risk

    Angiodynamics recalls DURAMAX STACKED TIP vascular access devices that may contain loosely affixed metal shavings. Metal shavings could embolize and potentially require surgical removal.

    Product
    DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028055
    Category
    Medical Device
    Distribution
    1 state
  • 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 (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 (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 (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-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-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-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 (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-1779-2024·2024-05-15

    Interact Discovery RT X-ray Systems Recalled for Component Fall Risk

    GE Healthcare is recalling certain x-ray systems because adhesive material may not be properly attached to bolts, which could cause components to fall during use.

    Product
    GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1777-2024·2024-05-15

    GE Healthcare X-Ray Systems Recalled for Loose Bolts on Gantry Assembly

    GE Healthcare is recalling x-ray imaging systems because adhesive on critical bolts may not have been applied, potentially causing the detector or x-ray tube to fall. The recall affects 21 units worldwide.

    Product
    GE Healthcare Innova IGS 5, computed tomography x-ray system
    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 (Devices)·Z-1766-2024·2024-05-15

    Medical Device Recall: Angiodynamics DURAMAX Tunneler with Metal Shavings

    Angiodynamics is recalling DURAMAX STACKED TIP medical devices that may contain loosely affixed metal shavings with potential to embolize, requiring possible surgical removal. The recall affects 50 units distributed in Virginia.

    Product
    DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1772-2024·2024-05-15

    Angiodynamics vascular access catheter subject to voluntary recall

    Angiodynamics has voluntarily recalled 285 units of DURAMAX STACKED TIP vascular access catheters (lots 5807195 and 5807196) used for hemodialysis. The specific reason for the recall is not disclosed in the FDA notice.

    Product
    DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028195
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1784-2024·2024-05-15

    X-ray C-arm Tabletop Recalled for Risk of Uncontrolled Motion

    NRT X-RAY A/S recalls Intelli-C X-ray tabletops due to faulty firmware and worn motor components that may cause uncontrolled C-arm motion, potentially striking patients or operators.

    Product
    Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-1781-2024·2024-05-15

    GE Allia IGS Fluoroscopic X-Ray Systems Adhesive Bolt Defect

    GE Healthcare recalled certain Allia IGS and related fluoroscopic x-ray systems due to potential incomplete adhesive on bolts in the gantry assembly, risking detector or tube failure.

    Product
    GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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
  • 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-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-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-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 (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