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

Medtronic Recalls Stent System Due to Migration Risk

Medtronic recalled its Abre Venous Self-Expanding Stent System on December 4, 2025, due to a potential Nitinol anomaly. This issue may lead to reduced stent diameter and corresponding radial force, increasing the risk of stent migration. The recall affects 442 units distributed worldwide, including the U.S.

Medtronic
Stents may
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HIGHFDA DEVICE

Mobius Imaging Recalls AIRO CT X-ray Pendant Due to Safety Risk

Mobius Imaging recalled 26 units of the Detachable 10in Pendant Upgrade for the AIRO CT X-ray System on December 4, 2025. The devices lack a critical "Safe Hand Position Warning" label, posing a high risk during operation. Healthcare providers and patients must cease use immediately and follow the manufacturer's instructions.

Mobius Imaging
AIRO pendant
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HIGHFDA FOOD

AZ Gems Recalls Jumbo Raw Shrimp Over Chloramphenicol Risk

AZ Gems, Inc. recalled 1,099 cases of Jumbo RAW SHRIMP on December 4, 2025, due to elevated chloramphenicol levels. The shrimp, sold under the Member's Mark label, poses a significant health risk. Consumers should not consume the product and seek refunds or replacements immediately.

AZ Gems
elevated levels
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HIGHFDA DEVICE

Merit Medical Inflation Device Recalled Over Handle Detachment Risk

Merit Medical Systems recalled 4,163,123 inflation devices on December 4, 2025, due to a risk that the handle may detach during use. This defect poses a high hazard to patients and healthcare providers. Consumers should stop using the device immediately and follow the manufacturer’s instructions for returns.

Merit Medical Systems
Inflation device
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HIGHFDA DEVICE

Merit Medical Recalls Custom Procedure Kits Due to Detachment Hazard

Merit Medical Systems recalled multiple Custom Procedure Kits on December 4, 2025, due to a risk of the inflation device handle detaching from the syringe during use. The recall affects several reference numbers sold worldwide, including in the U.S. and various international markets.

Merit Medical Systems
Inflation device
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HIGHFDA DEVICE

Merit Medical Systems Recalls Angioplasty Packs Over Detachment Hazard

Merit Medical Systems recalled 328,000 angioplasty packs on December 4, 2025, due to a risk of the inflation device handle detaching during procedures. The recall affects devices distributed worldwide, including states across the U.S. Healthcare providers and patients must stop using the devices immediately.

Merit Medical Systems
Inflation device
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HIGHFDA DEVICE

Intuitive Surgical Recalls Ion Vision Probe Bag Over Sterility Risk

Intuitive Surgical recalled 110,580 Ion Vision Probe Bags on December 4, 2025, due to compromised sterile seals. The recall affects devices distributed throughout the United States and several countries including Australia and Germany. Patients and healthcare providers should stop using the product immediately.

Intuitive Surgical
Due to
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HIGHFDA FOOD

McCain Foods Recalls Ore-Ida Tater Tots Due to Plastic Fragments

McCain Foods USA Inc recalled 21,256 cases of Ore-Ida Tater Tots on December 3, 2025. The recall follows reports of clear hard plastic fragments found in the product. Consumers should not consume the product and should seek refunds or replacements immediately.

McCain Foods USA
Clear hard
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HIGHNHTSA

BMW Recalls 2025 X3 for Brake Hose Issues That Risk Crashes

BMW of North America recalled certain 2025 X3 30 xDrive and X3 M50 xDrive vehicles due to leaking rear brake hoses. This defect may lead to a loss of rear braking function and the failure of the Antilock Brake System and Dynamic Stability Control. Owners will receive notification letters mailed on May 9, 2025.

BMW
A loss
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HIGHFDA DEVICE

Boston Scientific Recalls Balloon Catheters Over Inflation Issues

Boston Scientific recalled 21,000 Coyote Over-the-Wire PTA Balloon Dilation Catheters on December 3, 2025. The recall affects devices that may not properly inflate or deflate, posing a risk during medical procedures. Patients and healthcare providers should stop using these devices immediately and follow the recall instructions.

Boston Scientific
Boston Scientific
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HIGHFDA DEVICE

Philips Incisive CT Recalled Over Scan Incompletion Risk

Philips Healthcare recalled 35 Incisive CT scanners on December 3, 2025. The devices may produce incomplete scans due to an unstable connection inside the floating sensor. Healthcare providers must stop using these devices immediately and follow recall instructions.

Philips Healthcare
Potential for
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HIGHFDA FOOD

Sysco Recalls Frozen Potato Product Over Hard Plastic Fragments

Sysco Corporation recalled 17,597 cases of frozen potato product on December 3, 2025. The recall affects Sysco Imperial Potato Tater Barrel due to the presence of clear hard plastic fragments. Consumers should not consume this product and seek refunds immediately.

Sysco
Clear hard
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HIGHFDA DEVICE

Philips MR 7700 Systems Recalled Due to Stiffness Value Errors

Philips North America recalled 9 MR 7700 systems on December 3, 2025, due to potential errors in stiffness maps. The recall affects models with software versions R11.1 and R12.1, posing a high hazard risk. Healthcare providers must stop using these devices immediately and follow manufacturer instructions.

Philips North America
The potential
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HIGHFDA DEVICE

Philips North America Recalls MR Systems Over Stiffness Value Errors

Philips North America recalled one unit of its Evolution Upgrade 3.0T on December 3, 2025, due to potential stiffness value errors in MR Elastography stiffness maps. The issue affects software versions R11.1 and R12.1. Affected units may misrepresent medical imaging data, posing risks to patient diagnoses.

Philips North America
The potential
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HIGHFDA DEVICE

Philips Recalls Ingenia Elition S MR Systems Over Stiffness Errors

Philips North America recalled five Ingenia Elition S MR systems on December 3, 2025. The recall affects systems with software versions R11.1 and R12.1 due to potential errors in stiffness value readings. This issue poses a serious risk to patient safety when interpreting MR Elastography maps.

Philips North America
The potential
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