Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalls Sphincterotome Due to Deformation Risk
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which
burn risk Recalls
471 recalls tagged with “burn risk”.
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
Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalls Sphincterotome Due to Risk of Deformation
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which
Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalls Sphincterotome Over Potential Performance Issues
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which
Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalls Sphincterotome Due to High Risk of Deformation
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which
Health & Personal Care
HIGH
FDA DEVICE
Olympus Sphincterotome Recalled Due to Deformation Risk
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which
Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalls Sphincterotome Over Risk of Deformation
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which
Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalls Sphincterotome Due to Performance Risks
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which
Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalls Sphincterotome Due to Performance Risk
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which
Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalls Sphincterotome Due to Hazardous Deformation Risk
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which
Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalls Sphincterotome Due to Performance Risk
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which
Health & Personal Care
HIGH
FDA 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
Medline has
Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalls Sphincterotome Due to Risk of Deformation
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which
Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalls Sphincterotome V Due to Deformation Risk
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which
Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalls Sphincterotome Due to Performance Risk
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which
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
Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalls Single Use Sphincterotome Over Performance Risk
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which
Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalls Sphincterotome Over Performance Risks
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which
Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalls Sphincterotome Due to Deformation Risk
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which
Health & Personal Care
HIGH
FDA DEVICE
Olympus Recalls Sphincterotome Over Deformation Risk
Devices which did not undergo thermoforming could deform and lose performance.
Olympus Corporation of the Americas
Devices which
Tag Statistics
Total Recalls
471