The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

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.

1951–1975 of 29084

  • SevereFDA (Drugs)·D-0416-2025·2025-05-14

    Testosterone Pellet 200 mg Recalled for Glass Particulate Matter

    BSO LLC is recalling Testosterone Pellet 200 mg compounded drug vials nationwide because glass particles were found in the pellets intended for subcutaneous injection.

    Product
    TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0121-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0409-2025·2025-05-14

    FentaNYL and Ropivacaine Epidural Injection Recalled Due to Sterility Concerns

    Apollo Care, LLC is recalling FentaNYL 500mcg/2mcg/mL and Ropivacaine HCl 250mg/0.1% epidural injection due to lack of assurance of sterility. The recall affects 440 bags of a single lot distributed in Missouri.

    Product
    FentaNYL 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (0.1%) added to 250 mL, 0.9% Sodium Chloride Injection (For Epidural Use Only), Sterile, Single-Use Container, Rx Only, Apollocare, 3801 Mojave Ct, Ste 101, Columbia, MO 65202, NDC 71170-950-25
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0756-2025·2025-05-14

    Bone & Joint Restore capsules recalled for potential salmonella contamination

    Optimal Carnivore, LLC is recalling Bone & Joint Restore capsules nationwide due to potential contamination with salmonella. Consumers should stop using the product and contact the manufacturer.

    Product
    Bone & Joint Restore. 180 capsules in a plastic bottle. Shelf life two years. Store at ambient temperature. Optimal Carnivore LLC 1603 Capitol Ave Ste 310 WY371 Cheyenne, WY 82001
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V255000·2025-05-12

    Mercedes-Benz Recalls Vehicles With Incorrect Fuse Boxes From Prior Repair

    Mercedes-Benz is recalling 443 vehicles that received an incorrect fuse box during a previous recall. The defect may cause loss of drive power, safety functions, or fire.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, MERCEDES-MAYBACH AMG EQS 53 4MATIC, AMG SL55 4MATIC+, AMG EQE 53 4MATIC, AMG SL63 4MATIC+
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V316000·2025-05-09

    Ford Explorer front subframe mounting bolts may be improperly tightened

    Ford is recalling certain 2025 Explorer and Lincoln Aviator vehicles because a mounting bolt for the front subframe may have been tightened improperly. 206 units affected.

    Product
    LINCOLN — LINCOLN, FORD AVIATOR, EXPLORER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V314000·2025-05-09

    Ford Expedition front brake lines may contact the air cleaner pipe

    Ford is recalling certain 2022-2024 Expedition and Lincoln Navigator vehicles because front brake lines may contact the engine air cleaner outlet pipe and leak brake fluid.

    Product
    FORD — FORD, LINCOLN EXPEDITION, NAVIGATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V309000·2025-05-09

    Ford Recalls 2025 F-150 Trucks for Steering Shaft Fastener Defect

    Ford is recalling 2025 F-150 vehicles because lower steering shaft fasteners may detach, causing loss of steering control and increasing crash risk.

    Product
    FORD — FORD F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V308000·2025-05-09

    Ford Bronco lower control arms may detach; owners told not to drive

    Ford is recalling certain 2024-2025 Bronco vehicles because front lower control arm fasteners may not be tightened, allowing the arm to detach. Owners are told not to drive.

    Product
    FORD — FORD BRONCO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V310000·2025-05-09

    Ford Bronco upper control arm ball joint fasteners may be missing

    Ford is recalling certain 2024-2025 Bronco and Ranger vehicles because the front upper control arm ball joint fastener may be missing or improperly tightened.

    Product
    FORD — FORD BRONCO, RANGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·25253·2025-05-08

    Igloo 90 Qt. Rolling Coolers Recalled for Fingertip Amputation Risk

    Igloo has expanded its recall of 90 Qt. Flip & Tow Rolling Coolers due to tow handle pinching hazards that can cause fingertip amputation or crushing injuries. About 130,000 additional coolers manufactured prior to January 2024 are affected.

    Product
    Igloo 90 Qt. Flip & Tow Rolling Coolers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·25E033000·2025-05-08

    Chrysler Recalls Mopar Side Curtain Air Bags for Seam Defects

    Chrysler is recalling specific Mopar side curtain air bags because improperly sealed seams may cause insufficient pressure retention, increasing the risk of ejection and injury during a crash.

    Product
    AIR BAGS:SIDE/WINDOW:CURTAIN recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·25V300000·2025-05-08

    Aston Martin Recalls 2024 Valkyrie Vehicles Due to Wiring Harness Risk

    Aston Martin is recalling 2024 Valkyrie vehicles because incorrect screws may damage the wiring harness, potentially causing loss of critical functions and increasing crash risk.

    Product
    ASTON MARTIN — ASTON MARTIN VALKYRIE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1638-2025·2025-05-07

    GE Healthcare CARESTATION Anesthesia Systems may not ventilate properly

    GE Healthcare is recalling certain CARESTATION anesthesia systems that may fail to provide effective ventilation in Volume Control Ventilation mode. Alternative ventilation modes remain functional.

    Product
    GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1631-2025·2025-05-07

    GE Healthcare Carestation Anesthesia Systems Ventilation Defect Recall

    Certain GE Healthcare Carestation anesthesia delivery systems may fail to provide effective ventilation in Volume Control Ventilation (VCV) mode. Affected systems can still be used safely in Pressure Control Ventilation or Manual ventilation modes.

    Product
    GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1701-2025·2025-05-07

    L-Shaped Femoral Augment with Missing Screw Thread

    Waldemar Link GmbH & Co. KG is recalling L-Shaped Femoral Augments because the preassembled femoral augment screw was missing its thread. The defect could affect the device's structural integrity during orthopedic surgery.

    Product
    L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5) 880-323/13 (Sz. 3-4 - cemented sm), (6) 880-323/23 (Sz. 3-4 - cemented lg), (7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1635-2025·2025-05-07

    GE Healthcare CARESTATION 750 Anesthesia System Volume Control Ventilation Failure

    Certain GE Healthcare CARESTATION 750 anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation mode. Affected systems can deliver ventilation through alternative modes or manual ventilation.

    Product
    GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1699-2025·2025-05-07

    Distal Femoral Augment medical device recall for defective screw

    Waldemar Link GmbH & Co. KG is recalling Distal Femoral Augment devices because the preassembled femoral augment screw was missing its thread. The defect may affect proper device function.

    Product
    Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented sm), (4) 880-301/21 (Sz. 1-2 - cemented lg), (5) 880-303/11 (Sz. 3-4 - cemented sm), (6) 880-303/12 (Sz. 3-4 - cemented md), (7) 88
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1625-2025·2025-05-07

    GE Healthcare CARESTATION 620 A2 Anesthesia System Ventilation Failure

    Certain GE Healthcare CARESTATION anesthesia systems may fail to provide effective ventilation in Volume Control Ventilation (VCV) mode. Alternative ventilation modes or manual ventilation can be used.

    Product
    GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1702-2025·2025-05-07

    Tibial Augment devices recalled for missing screw thread

    Waldemar Link GmbH & Co. KG is recalling Tibial Augment devices distributed nationwide because preassembled Femoral Augment screws were delivered missing their threads.

    Product
    Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md), (4) 880-331/21 (Sz. 1-2 - cemented lg), (5) 880-331/22 (Sz. 1-2 - cemented x-lg), (6) 880-331/23 (Sz. 1-2 - cemented xx-lg), (7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1695-2025·2025-05-07

    Quantum Informatics VIPER Physiological Monitor Recalled for Lack of FDA Clearance

    Spectrum Medical Ltd. is recalling the Quantum Informatics VIPER, a patient monitoring software device, because it was marketed without required FDA clearance. The software is used in operating rooms to provide patient safety information.

    Product
    Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-time patient safety and clinical best practice soluti
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Devices)·Z-1636-2025·2025-05-07

    GE Healthcare CARESTATION Anesthesia Systems Ventilation Mode Failure Recall

    Certain GE Healthcare CARESTATION 750 A2 anesthesia systems may not provide effective ventilation in Volume Control Ventilation mode. Users should switch to Pressure Control Ventilation or Manual ventilation modes.

    Product
    GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1700-2025·2025-05-07

    Posterior Femoral Augment with Missing Screw Thread Recalled

    Waldemar Link is recalling Posterior Femoral Augments used in knee surgery because some units were delivered with a preassembled screw missing its thread, which could compromise surgical fixation.

    Product
    Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cemented sm), (4) 880-311/21 (Sz. 1-2 - cemented lg), (5) 880-313/11 (Sz. 3-4 - cemented sm), (6) 880-313/12 (Sz. 3-4 - cemented md), (7)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1704-2025·2025-05-07

    Enhanced Verify Evaluation Handset May Fail to Connect to Neurostimulator

    Medtronic Enhanced Verify Evaluation Handsets (CFN HH90130FA) may fail to communicate with neurostimulators due to faster processing speed, causing therapy to stop and patients to experience return of underlying symptoms.

    Product
    Enhanced Verify Evaluation Handset (CFN HH90130FA)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1629-2025·2025-05-07

    GE Healthcare CARESTATION anesthesia systems may not ventilate effectively

    Certain GE Healthcare CARESTATION 620, 650, 650c, 750, and 750c anesthesia delivery systems may not provide effective ventilation in Volume Control Ventilation (VCV) mode. Effective ventilation is available using other ventilation modes or manual ventilation.

    Product
    GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0398-2025·2025-05-07

    Nicardipine Hydrochloride Injection Recalled for Potential Sterility Issues

    American Regent, Inc. is recalling Nicardipine Hydrochloride Injection due to product leakage around the vial neck that could compromise sterility assurance. The recall affects multiple lots distributed nationwide.

    Product
    NICARDIPINE HYDROCHLORIDE — NICARDIPINE HYDROCHLORIDE (NICARDIPINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide