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

2,168 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

Olympus Recalls Sphincterotome Over Deformation Risk

Olympus Corporation of the Americas recalled 17,655 sphincterotomes on January 7, 2026. The devices may deform due to improper thermoforming, affecting performance. Patients and healthcare providers must stop using the devices immediately.

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HIGHFDA DEVICE

Olympus Recalls Sphincterotome Due to Deformation Risk

Olympus Corporation of the Americas recalled 10,257 Single Use 3-Lumen Sphincterotome V devices on January 7, 2026. The recall follows reports that some devices did not undergo thermoforming, risking deformation and loss of performance during medical procedures. This recall affects both domestic and international distribution, including 274 units in the U.S.

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HIGHFDA DEVICE

Olympus Recalls Sphincterotome Due to Potential Deformity Hazard

Olympus Corporation of the Americas recalled 3,954 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The recall occurred due to devices that may not have undergone proper thermoforming, risking deformation and loss of performance. Healthcare providers and patients should stop using the devices immediately and follow the recall instructions.

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HIGHFDA DEVICE

Olympus Recalls Sphincterotome Due to Performance Risk

Olympus Corporation of the Americas recalled 33,433 units of its Single Use 3-Lumen Sphincterotome V on January 7, 2026. Devices that did not undergo thermoforming may deform and lose performance, posing a high risk to patients. Healthcare providers and patients should stop using the device immediately.

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HIGHFDA DEVICE

Philips North America Recalls CT Scanner Over Rotor Fastener Issue

Philips North America recalled 47 CT scanners on January 7, 2026, due to improperly torqued rotor fasteners. This issue could lead to unsecured rotor parts, posing a high risk during operation. Patients and healthcare providers must stop using the device immediately.

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HIGHFDA DEVICE

Olympus Recalls Sphincterotome Due to Deformation Risk

Olympus Corporation of the Americas recalled 1,025 units of its Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform due to inadequate thermoforming, posing a high hazard level. Patients and healthcare providers must stop using the devices immediately and follow recall instructions.

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HIGHFDA DEVICE

Olympus Recalls Sphincterotome Due to Deformation Risk

Olympus Corporation of the Americas recalled 1,072 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall addresses devices that did not undergo proper thermoforming, risking performance failure. Healthcare providers and patients should stop using the devices immediately.

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HIGHFDA DEVICE

Olympus Sphincterotome Recalled Due to Deformation Risk

Olympus Corporation recalled 1,474 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform and lose performance due to improper thermoforming. Healthcare providers and patients must stop using these instruments immediately.

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HIGHFDA DEVICE

Olympus Recalls Sphincterotome Due to High Hazard Risk

Olympus Corporation recalled 887 units of the Disposable Triple Lumen Sphincterotome on January 7, 2026. The devices may deform and lose performance if not properly thermoformed. The recall affects both US and international markets.

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HIGHFDA DEVICE

Olympus Recalls Sphincterotome Over Performance Risks

Olympus Corporation of the Americas recalled 10,008 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform and lose performance due to a manufacturing issue. Healthcare providers and patients must stop using them immediately.

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HIGHFDA DEVICE

Philips Recalls Spectral CT 7500 Over Fastener Issues

Philips North America recalled three Spectral CT 7500 units on January 7, 2026. The recall affects models with potential fastener issues that could lead to unsecured rotor parts. Patients and healthcare providers should stop using the device immediately.

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HIGHFDA DEVICE

Philips Recalls IQon Spectral CT Over Potential Rotor Hazards

Philips North America recalled 52 units of the IQon Spectral CT on January 7, 2026, due to fasteners that may not be torqued to specification. This defect may lead to unsecured rotor parts during operation. No injuries have been reported, but the potential for parts to be expelled during gantry rotation poses a safety risk.

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HIGHNHTSA

Ford Explorer Recalled for Engine Failure Risk

Ford Motor Company recalled certain 2025 Explorer vehicles due to engine defects. The recall affects vehicles with potentially faulty connecting rods that could lead to engine failure. Owners received notification letters on August 15, 2025, and should contact Ford for repairs.

Ford Motor Company
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HIGHNHTSA

Ford Recalls 2025 F-250 SD for Hydraulic Brake Failure Risk

Ford Motor Company recalled certain 2025 F-250 SD vehicles due to a defect in the brake system. The brake booster pushrod retaining spring may not have been installed, risking sudden brake failure. Owners should not drive these vehicles until repairs are completed.

Ford Motor Company
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HIGHNHTSA

Ford Explorer Recalled for Seat Malfunction Increasing Injury Risk

Ford Motor Company recalled certain 2020-2025 Explorer vehicles due to a potential seat malfunction. The issue involves the second-row outer seat switch, which may bind or stick, causing the seats to unlatch unexpectedly. This recall affects multiple units and was announced on January 6, 2026.

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HIGHFDA DEVICE

VANTIVE US HEALTHCARE Recalls Dialyzer Over Dislodgement Risk

VANTIVE US HEALTHCARE recalled 115,112 units of the PRISMAFLEX HF1000 SET on January 6, 2026. The recall stems from a potential dislodgement of the deaeration chamber from the control unit. Healthcare providers and patients must stop using the device immediately.

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HIGHFDA DEVICE

VANTIVE US Healthcare Recalls Dialyzer Over Dislodgement Risk

VANTIVE US Healthcare recalled 230,596 units of the PRIMSAFLEX M100 Set on January 6, 2026. The recall follows a risk of dislodgement of the deaeration chamber from the control unit. Healthcare providers and patients must stop using the device immediately.

VANTIVE US HEALTHCARE
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HIGHFDA DEVICE

VANTIVE US HEALTHCARE Recalls Dialyzer Due to Dislodgement Hazard

VANTIVE US HEALTHCARE recalled 87,436 Prismaflex ST100 Dialyzers on January 6, 2026. The recall follows reports of potential dislodgement of the deaeration chamber from the control unit. Healthcare providers and patients must stop using the device immediately.

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