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

3,615 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
HIGH
FDA DEVICE

Medline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT UROLOGY SLING, Model Number: DYKMBNDL106A; 3) KIT UROLOGY PENILE REPAIR, Model Number: DYKMBNDL188; 4) KIT...

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Medline Industries, LP
Medline has
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HIGH
FDA DEVICE

Medline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model Number: DYNJ42829B; 3) BURN CARE PACK-LF, Model Number: DYNJT3437

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Risk of Deformation

Olympus Corporation of the Americas recalled 1,918 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The recall follows concerns that devices may deform and lose performance due to improper thermoforming. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Deformation Risk

Olympus Corporation of the Americas recalled 5,089 sphincterotomes on January 7, 2026, due to potential deformation. The devices may lose performance if they did not undergo thermoforming. Healthcare providers and patients should cease use immediately and follow recall instructions.

Olympus Corporation of the Americas
Devices which
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HIGH
FDA DEVICE

Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL...

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Medical Device Recalled Over Deformation Risk

Olympus Corporation recalled 4,183 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. Devices may deform and lose performance due to inadequate thermoforming. Healthcare providers should immediately stop using the affected products and follow recall instructions.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Over Deformation Risk

Olympus Corporation of the Americas recalled 93 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform and lose performance due to a manufacturing flaw. Healthcare providers and patients should stop using the device immediately and follow recall instructions.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

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
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Medline Recalls Convenience Kits Over Sterility Issues

Medline Industries, LP recalled 684 medical convenience kits on January 7, 2026. The recall affects the LVAD Driveline Tray and the KIT Surg Onc Insert Cent. Venou due to calibration issues impacting sterility. Health providers and patients should stop using these products immediately.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Over Performance Risks

Olympus Corporation of the Americas recalled 5,946 single use sphincterotomes on January 7, 2026. The devices may deform and lose performance due to improper thermoforming. Healthcare providers and patients must cease use immediately to avoid potential hazards.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA 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.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA 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.

Olympus Corporation of the Americas
Devices which
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HIGH
FDA DEVICE

Medline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART ANESTHESIA ICC-A, Model Number:DYNJ905567A

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Medline Industries, LP
Medline has
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Health & Personal Care
HIGH
FDA 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.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Over Potential Performance Issues

Olympus Corporation of the Americas recalled 1,980 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall affects devices that did not undergo thermoforming, risking deformation and loss of performance. Healthcare providers must stop using these devices immediately.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to High Risk of Deformation

Olympus Corporation of the Americas recalled 125 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall affects devices that did not undergo proper thermoforming, risking deformation and performance loss. Healthcare providers must stop using these devices immediately.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Sphincterotome Recalled Due to Deformation Risk

Olympus Corporation of the Americas recalled 7,689 Disposable Triple Lumen Sphincterotomes on January 7, 2026. The devices may deform due to inadequate thermoforming, risking performance failure during medical procedures. Healthcare providers must stop using these devices immediately and follow recall instructions.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Over Risk of Deformation

Olympus Corporation of the Americas recalled 1,490 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The devices may deform due to improper thermoforming, risking performance failure. Healthcare providers should immediately stop using these devices and follow recall instructions.

Olympus Corporation of the Americas
Devices which
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Health & Personal Care
HIGH
FDA DEVICE

Olympus Recalls Sphincterotome Due to Performance Risks

Olympus Corporation of the Americas recalled 886 units of its Disposable Triple Lumen Sphincterotome on January 7, 2026. The recall follows reports that devices not properly thermoformed could deform and lose performance. Patients and healthcare providers should stop using the device immediately.

Olympus Corporation of the Americas
Devices which
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