2,142 recalls tagged with “cpsc regulated”.
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.
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.
Olympus Corporation of the Americas recalled 65,117 Single Use 3-Lumen Sphincterotome V devices on January 7, 2026. Improper thermoforming may cause the devices to deform and lose performance. Users should stop using the device immediately and follow the manufacturer’s instructions.
Olympus Corporation of the Americas recalled 7,046 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The recall affects devices that did not undergo proper thermoforming, risking deformation and performance loss. Healthcare providers and patients must stop using these devices immediately.
Olympus Corporation of the Americas recalled 650 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 should stop using these instruments immediately.
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.
Olympus Corporation of the Americas recalled 2,344 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The devices may deform due to improper thermoforming, leading to performance issues. This recall affects units distributed worldwide, including all U.S. states.
Olympus Corporation recalled 86,303 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. This recall affects devices distributed worldwide, including 1,803 units in the U.S.
Olympus Corporation of the Americas recalled 30,489 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. The recall stems from devices that failed to undergo proper thermoforming, risking deformation and performance loss. Healthcare providers and patients must stop using the device immediately.
Olympus Corporation of the Americas recalled 136,037 Single Use 3-Lumen Sphincterotome V devices on January 7, 2026. The recall affects devices that did not undergo proper thermoforming, risking deformation and loss of performance. Healthcare providers and patients must stop using the devices immediately.
Medline recalled 5,346 convenience kits on January 7, 2026, due to sterilization calibration issues. The recall affects multiple model numbers, potentially compromising their sterility assurance. Healthcare providers and patients must stop using the products immediately.
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.
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 recalled 72 units of Drape Pack-Choice, Model DYNJ63118A, on January 7, 2026. Calibration issues in sterilization equipment may compromise product sterility. Patients and healthcare providers should stop using the device immediately.
Medline Industries recalled 59 urology convenience kits on January 7, 2026, due to sterilization calibration issues. These defects may compromise the sterility assurance level of the devices. Patients and healthcare providers should immediately stop using these products and follow recall instructions.
VANTIVE US HEALTHCARE recalled 13,760 Prismaflex TPE2000 Sets on January 6, 2026, due to a potential dislodgement hazard. The recall affects the deaeration chamber of the Prismaflex Control Unit. Healthcare providers and patients must stop using the device immediately.
Herbs Forever recalled 45 units of Hingwastika Churna on January 6, 2026. The product may contain undeclared wheat, posing a health risk to consumers with wheat allergies. Customers should stop using the product immediately and contact the company for a refund or replacement.
Encon Safety Products recalls AQ 120 GFEW Aquarion Preserved Cartridges sold nationwide through multiple retailers. The recall cites cGMP deviations in manufacturing. Stop using the product immediately and follow recall guidance from Encon Safety or your healthcare provider.
HerbsForever recalled 45 units of its Gastro Care Ayurvedic Herbal Supplement on January 6, 2026. The recall follows the discovery of a potential undeclared allergen, wheat, which poses a serious risk to consumers with wheat allergies. Affected products were sold online nationwide.
Straumann USA recalled 561 units of its Impression Post Closed Tray on January 6, 2026. The recall occurred due to a mix-up where impression caps were mistakenly packaged in magenta instead of the intended brown. Healthcare providers and patients must stop using the device immediately.