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

2,247 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.

Olympus Corporation of the Americas
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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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HIGHFDA DEVICE

Medline Convenience Kits Recalled Due to Sterility Concerns

Medline Industries recalled 7,725 surgical kits on January 7, 2026, due to potential sterility issues. Calibration problems with sterilization equipment may compromise the sterility assurance level. Healthcare providers and patients should stop using these kits immediately.

Medline Industries, LP
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HIGHFDA DEVICE

Medline Surgical Kits Recalled Over Sterility Concerns

Medline Industries recalled 9,051 surgical kits on January 7, 2026, due to sterilization calibration issues. The recall affects multiple model numbers and poses a high hazard risk. Patients and healthcare providers should stop using these products immediately.

Medline Industries, LP
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HIGHFDA DEVICE

Medline Convenience Kits Recalled Due to Sterility Concerns

Medline recalled 108 units of its Convenience Kits, model DYKMBNDL200A, due to calibration issues affecting sterility. The recall, issued on January 7, 2026, impacts products distributed worldwide. Healthcare providers and patients must stop using the kits immediately.

Medline Industries, LP
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Medline Recalls Convenience Kits Over Sterility Concerns

Medline Industries recalled 9,720 convenience kits on January 7, 2026, due to sterilization calibration issues. The affected products may not meet sterility assurance levels. Patients and healthcare providers should stop using these kits immediately.

Medline Industries, LP
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HIGHFDA DEVICE

Medline Recalls Surgical Kits Over Sterility Concerns

Medline Industries recalled 12,418 surgical kits on January 7, 2026, after identifying calibration issues in sterilization equipment. The defects could compromise sterility assurance levels of the devices. Healthcare providers and patients must stop using the affected products immediately.

Medline Industries, LP
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HIGHFDA DEVICE

Medline Convenience Kits Recalled Due to Sterilization Issues

Medline Industries recalled 32 units of Convenience Kits on January 7, 2026. Issues with sterilization equipment calibration may compromise device safety. Users should stop using the products immediately and follow recall instructions.

Medline Industries, LP
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HIGHFDA DEVICE

Medline Convenience Kits Recalled Over Sterility Concerns

Medline Industries recalled 23,238 convenience kits on January 7, 2026. The recall affects the BAPTIST FLOYD ENDO GI KIT and GI LAB OTHER ENDO KIT due to calibration issues that may compromise sterility. Patients and healthcare providers should stop using the products immediately.

Medline Industries, LP
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