1,716 recalls tagged with “cpsc regulated”.
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 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 recalled 1,504 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 should stop using the devices immediately.
Olympus Corporation of the Americas recalled 12,641 Single Use Sphincterotome V devices on January 7, 2026. The devices may deform due to a manufacturing defect, posing a high risk of performance failure. Healthcare providers and patients must stop using these instruments 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.
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.
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.
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.
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.
Philips North America recalled 283 Spectral CT units on January 7, 2026. Fasteners in the device may not be torqued to specification, posing a risk of unsecured rotor parts. While no incidents have been reported, potential safety hazards exist.
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 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 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 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 recalled 1,496 convenience kits on January 7, 2026, due to sterilization calibration issues. The recall affects various models, potentially compromising sterility assurance levels. Patients and healthcare providers must stop using these devices immediately.
Medline Industries recalled 2,236 dental packs on January 7, 2026, due to calibration issues affecting sterilization. The recall impacts products distributed worldwide, raising safety concerns for healthcare providers. Consumers should stop using the recalled items immediately and follow manufacturer instructions.
Medline Industries recalled 175 arthroscopy kits on January 7, 2026. Calibration issues with sterilization equipment may impact product sterility. Patients and healthcare providers should stop using the devices immediately.
Medline Industries recalled 30,958 convenience kits on January 7, 2026. Calibration issues with sterilization equipment may compromise product sterility. Healthcare providers and patients must stop using these products immediately.
Medline Industries recalled 14.9 million surgical drapes on January 7, 2026. Calibration issues with sterilization equipment may impact sterility assurance levels. Patients and healthcare providers must stop using these products immediately.
Medline Industries recalled 240 units of convenience kits on January 7, 2026. Calibration issues with sterilization equipment may impact product safety. Patients and healthcare providers should stop using these devices immediately.