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.

8951–8975 of 53036

  • 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
  • HighNHTSA·24V344000·2024-05-15

    2021-2023 Volkswagen ID.4 display software defect increases crash risk

    Certain 2021-2023 Volkswagen ID.4 vehicles experience a software issue causing display failures that hide the speedometer and rearview camera. Dealers will update the software at no cost.

    Product
    VOLKSWAGEN — VOLKSWAGEN ID.4
    Category
    Vehicle
    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-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-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 (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
    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 (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-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 (Drugs)·D-0482-2024·2024-05-15

    Duloxetine prescription capsules recalled for N-nitroso impurity exceeding FDA limits

    Breckenridge Pharmaceutical recalls Duloxetine 30mg delayed-release capsules nationwide due to N-nitroso-duloxetine impurity exceeding FDA-recommended interim limits. The impurity was identified as a CGMP manufacturing deviation.

    Product
    DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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 (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-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 (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-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
  • HighNHTSA·24V340000·2024-05-15

    2025 MINI Countryman Rear Armrest May Detach During Airbag Deployment

    BMW is recalling 9 2025 MINI Countryman vehicles because the armrest support bracket on the rear side door panel may be improperly secured and detach during an airbag deployment, potentially striking occupants or interfering with airbag function.

    Product
    MINI — MINI COUNTRYMAN
    Category
    Vehicle
    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
    2 states
  • HighFDA (Food)·F-1225-2024·2024-05-15

    DB Yummers Barbecue Sauce Recalled Due to Improper Thermal Processing

    DB Yummers Sweet & Smokey Barbecue Sauce is recalled for lacking FDA-approved heat treatment. Bottles with best-by dates 05/18/25, 05/26/25, or 08/30/25 distributed in Kentucky and Ohio should not be consumed.

    Product
    DB Yummers Sweet & Smokey Barbeque Sauce packaged in 19.5 glass bottles, 12 bottles per case, UPC 74872001101.
    Category
    Food
    Distribution
    2 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
    2 states
  • HighFDA (Devices)·Z-1757-2024·2024-05-15

    Philips 5000 Compact Series Ultrasound Systems pose uncontrolled burn risk

    Philips 5000 Compact Series ultrasound systems may leave unselected transesophageal transducers powered without temperature monitoring, risking patient burns during imaging procedures.

    Product
    5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300 W/795146, 5300 P/795147, 5300 G/795148, used with Deluxe and Premium Carts that come with multiport adapters.
    Category
    Medical Device
    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-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 (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
  • HighNHTSA·24V339000·2024-05-15

    Multiple travel trailers recalled for detaching freshwater tanks

    Forest River travel trailers may have freshwater tanks that detach when full, posing a road hazard. Dealers will install additional attachment straps at no cost.

    Product
    CLIPPER TOWABLE — CLIPPER TOWABLE, VIKING TOWABLE, INDEPENDENCE TRAIL TRAILE CWT182DBU, VWT182DBU, VWT262BHS, VWT26SBHSAGA
    Category
    Vehicle
    Distribution
    Distributed nationwide