These recalls involve products that pose serious risks of injury or death. Check if you own any of these products and take immediate action if needed.

High Risk Recalls

2,251 critical product recalls that require immediate attention. These products have been identified as posing serious safety hazards.

What to do if you own a recalled product:

  1. Stop using the product immediately
  2. Keep the product away from children
  3. Follow the remedy instructions provided
  4. Contact the manufacturer for a refund or replacement
HIGHFDA DEVICE

Philips North America Recalls MR Imaging System Over Stiffness Errors

Philips North America recalled three MR imaging systems on December 3, 2025, due to potential stiffness value errors in exported MR Elastography maps. The systems, identified by product code REF: 781270, have software versions R11.1 and R12.1. Users should stop using the devices immediately and contact their healthcare providers for further instructions.

Philips North America
The potential
Read more
HIGHFDA DEVICE

Philips MRI System Recalled Due to Stiffness Value Errors

Philips North America recalled 31 MRI systems on December 3, 2025, due to potential errors in stiffness value readings. The affected models include product codes 781358, 782107, and 782136 with software versions R11.1 and R12.1. Healthcare providers must stop using these devices immediately to prevent misdiagnosis.

Philips North America
The potential
Read more
HIGHFDA DEVICE

Philips North America Recalls Ingenia 3.0T MR Systems Over High Hazard

Philips North America recalled 24 Ingenia 3.0T MR systems on December 3, 2025, due to potential stiffness value errors in MR Elastography maps. The recall affects systems with software versions R11.1 and R12.1, distributed across multiple states and countries. Healthcare providers must stop using these devices immediately to prevent misdiagnosis.

Philips North America
The potential
Read more
HIGHFDA DEVICE

Philips North America Recalls MR Systems Over Stiffness Value Errors

Philips North America recalled three MR systems on December 3, 2025. The recall affects models with software versions R11.1 and R12.1 due to potential stiffness value errors. Healthcare providers and patients must stop using these devices immediately.

Philips North America
The potential
Read more
HIGHFDA DEVICE

Philips North America Issues Recall of MR Systems Due to High Hazard Risk

Philips North America recalled one unit of its MR system on December 3, 2025, due to potential stiffness value errors in MR Elastography maps. The recall affects systems with software versions R11.1 and R12.1, distributed worldwide. Healthcare providers should stop using the device immediately and follow the manufacturer's instructions.

Philips North America
The potential
Read more
HIGHFDA DEVICE

Philips Recalls Ingenia Ambition S MR Systems Over Stiffness Errors

Philips North America recalled Ingenia Ambition S MR systems on December 3, 2025, due to stiffness value errors in exported MR Elastography maps. The recall affects one unit distributed in multiple U.S. states and several countries. Users must stop using the device immediately and follow recall instructions.

Philips North America
The potential
Read more
HIGHFDA DEVICE

Philips Recalled Ingenia Ambition X MR Systems Over Stiffness Errors

Philips North America recalled 21 Ingenia Ambition X MR systems on December 3, 2025, due to potential stiffness value errors. The recall affects models with software versions R11.1 and R12.1, distributed in the U.S. and worldwide. Healthcare providers must stop using these devices immediately and follow provided instructions.

Philips North America
The potential
Read more
HIGHFDA DEVICE

Philips North America Recalls MR Systems Due to Stiffness Value Errors

Philips North America recalled 6 MR systems on December 3, 2025, due to the potential for stiffness value errors. These errors can occur when viewing exported MR Elastography stiffness maps on Picture Archiving and Communication Systems. Users should stop using the devices immediately and follow recall instructions.

Philips North America
The potential
Read more
HIGHFDA DEVICE

Philips Ingenia 1.5T MR Systems Recalled Over Stiffness Value Errors

Philips North America recalled 10 Ingenia 1.5T MR systems on December 3, 2025, due to potential stiffness value errors. The affected models include Product Codes 781341 and 781396 with software versions R11.1 and R12.1. Healthcare providers must stop using these devices immediately to prevent misdiagnosis.

Philips North America
The potential
Read more
HIGHNHTSA

Audi Q3 Recalled for Rearview Camera Software Issue

Volkswagen Group of America recalled certain 2024-2025 Audi Q3 vehicles on December 2, 2025. A camera control unit software error may prevent the rearview camera image from displaying. This issue increases the risk of a crash due to reduced rear visibility.

AUDI
A rearview
Read more
HIGHFDA DEVICE

Zimmer Recalls Affixus Femoral Nails Over Fatigue Fracture Risk

Zimmer, Inc. recalled 23 Affixus Antegrade Femoral Nails on December 2, 2025. These implants may have an undersized distal diameter that could lead to fatigue fractures. Patients should stop using the device immediately and contact their healthcare provider.

Zimmer
Affected implants
Read more
HIGHFDA DEVICE

Microbiologics Recalls LYFO DISK Due to Testing Failure Risk

Microbiologics recalled LYFO DISK, Catalog Number 0325L, on December 2, 2025, after reports indicated affected units may fail to recover Campylobacter jejuni. This recall affects one unit, with an additional 16 units added on December 22, 2025. The recall impacts products distributed worldwide, including the United States.

Microbiologics
Affected units
Read more
HIGHFDA FOOD

Wegmans Recalls Deluxe Mixed Nuts Over Salmonella Risk

Wegmans recalled 3,024 units of Deluxe Mixed Nuts on December 2, 2025. The recall stems from potential Salmonella contamination. Consumers should not consume the product and seek refunds immediately.

Mellace Family Brands California
Potential contamination
Read more
HIGHFDA DEVICE

Zimmer Recalls Affixus Femoral Nails Over Fracture Risk

Zimmer Inc. recalled 24 units of Affixus Antegrade Femoral Nails on December 2, 2025. The recall follows reports of undersized distal diameters that could lead to implant fatigue fractures. This defect poses a high risk of adverse tissue reactions and requires immediate action.

Zimmer
Affected implants
Read more
HIGHFDA DEVICE

Zimmer Recalls Affixus Antegrade Femoral Nails Due to Fracture Risk

Zimmer recalled 24 Affixus Antegrade Femoral Nails on December 2, 2025, due to potential implant fatigue fractures. The defective implants could cause severe health risks, including pain, tissue damage, and the need for additional surgery. Healthcare providers and patients must cease use immediately and follow recall protocols.

Zimmer
Affected implants
Read more
HIGHFDA DEVICE

Affixus Antegrade Femoral Nailing System Recalled Over Fracture Risk

Zimmer Inc. recalled 24 units of the Affixus Antegrade Femoral Nailing System on December 2, 2025. Affected implants may have an undersized distal diameter that could lead to implant fatigue fractures. Risks include pain, tissue damage, and potential surgical intervention.

Zimmer
Affected implants
Read more
HIGHFDA DEVICE

Zimmer Recalls Affixus Femoral Nails Due to Fracture Risk

Zimmer, Inc. recalled 11 units of the Affixus Antegrade Femoral Nails on December 2, 2025. Affected implants may have an undersized distal diameter, posing a risk of fatigue fracture. This defect could cause adverse reactions requiring surgical intervention.

Zimmer
Affected implants
Read more
Advertisement