1,264 recalls tagged with “fda regulated”.
GE HealthCare is recalling 28 Elscint SPX6 dual-head gamma cameras worldwide. The recall cites detectors could be stressed during transport or relocation without adequate detector support, risking a detector fall and life-threatening injury. Hospitals should stop using the devices and follow the manufacturer’s recall instructions.
UIH Technologies recalled 2 units of the uCT 780 MD computed tomography system after an FDA enforcement notice Z-0220-2026. A third-party outer cover can become trapped between the patient table and gantry, causing mechanical interference during table movement. Hospitals should stop using the device immediately and await instructions from UIH Technologies LLC or their healthcare provider.
UIH Technologies LLC recalls eight Shanghai United Imaging uCT 530 MD CT scanners sold to U.S. hospitals. Third‑party outer covers can become trapped between the patient table and gantry, causing mechanical interference during table movement. Hospitals should stop using the device immediately and follow recall instructions from UIH Technologies or their healthcare provider.
GE Medical Systems Israel recalls 15 Elscint Varicam dual-head gamma cameras worldwide. The recall cites a risk that devices moved without proper detector support, which could cause a detector fall. Clinicians should stop using the devices and follow manufacturer instructions immediately.
Shanghai United Imaging Healthcare recalled 22 CT X-ray systems, including the uCT 550 MD, sold to healthcare facilities in the United States. A third-party outer cover can become trapped between the patient table and gantry, causing mechanical interference during table movement. Stop using the device and follow the manufacturer’s recall instructions immediately.
GE HealthCare Israel recalled 37 Maxicam dual-head gamma cameras distributed worldwide to hospitals. The recall cites potential detector mounting stress if the devices are moved without adequate support. This could result in a detector fall and life-threatening injury. Hospitals and healthcare providers should stop using the device and follow recall instructions from GE HealthCare.
Argon Medical Devices recalled 1,821 Option Elite Vena Cava Filter System devices sold to U.S. hospitals and international distributors. The recall cites a dilator resistance issue within the introducer sheath that could slow procedures and injure venous tissue. Healthcare providers and patients should stop using the device immediately and follow the recall instructions.
GE HealthCare recalled 1,386 Millennium MG/MC dual-head gamma cameras used in cardiac imaging worldwide. The recall notes devices past End of Guaranteed Service may have been transported without adequate detector support, risking mounting failure and possible detector falls. Facilities should stop using the devices and await recall instructions sent by GE Medical Systems Israel, Functional Imaging
UIH Technologies LLC is recalling 4 Shanghai United Imaging Healthcare uMI Panorama 35 MD PET/CT systems sold in the United States. A third-party outer cover can become trapped between the patient table and gantry during table movement. Hospitals and clinics should stop using the devices and follow the manufacturer’s recall instructions.
Epoca International recalls Paris Hilton mini beauty fridges sold before August 2024 due to a shorting electrical switch that can overheat and cause a fire. Consumers should stop using the recalled units and seek a full refund. Details and how to claim are on Epoca’s recall page or by phone.
Theken Companies recalled 409 iNSitu Bipolar Hip System bipolar head implants distributed nationwide in New Jersey, Pennsylvania and Texas. The devices failed transit testing and may have a compromised sterile barrier. Hospitals and surgeons should stop using the device and follow recall instructions.
Boston Scientific recalled two UPN configurations of the LGX Preconnect with TENACIO Pump without InhibiZone due to potential inflation and deflation performance issues. The devices were distributed worldwide, including the US and Canada. Healthcare providers are instructed to stop use and follow manufacturer recall instructions.
Olympus Corporation of the Americas recalls 3,250 EVIS EXERA II BF-P180 Bronchovideoscopes sold in the United States and internationally. The recall updates the instructions for use to clarify safe and effective use with laser, argon plasma coagulation, and high-frequency therapy equipment. Healthcare providers should stop using the device immediately and contact Olympus for instructions.
Ferno-Washington Inc. recalled 138 Power X2 powered ambulance cots nationwide. The recall is due to fastening post hardware that could loosen and detach. Stop using the device and contact Ferno-Washington for instructions.
Boston Scientific is recalling 1 CX Preconnect with TENACIO Pump sold to healthcare providers worldwide, including the US and Canada. The device may experience inflation and/or deflation performance issues. Healthcare providers and patients should stop using the device and follow manufacturer recall instructions.
Olympus BF-H1100 bronchovideoscopes sold nationwide in the US were recalled. The recall updates the IFU to clarify safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. Stop using the device immediately and follow the manufacturer’s recall instructions.
Olympus Corporation of the Americas recalled 1,473 US units and 3,774 non-US units of the EVIS EXERA II bronchovideoscope BF-1T180. The recall concerns updated instructions for safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. Stop using the device immediately and follow manufacturer instructions.
Olympus Corporation of the Americas reports an active recall for the BRONCHOVIDEOSCOPE BF-1TH1100. The recall concerns additional IFU updates for safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. The company urges stopping use and following recall instructions.
Boston Scientific recalled 172 units of the CXR Preconnect with TENACIO Pump with InhibiZone worldwide. The recall was initiated on 2025-09-11 and remains active as of 2025-10-22. The devices can experience inflation and/or deflation performance issues. Healthcare providers should stop using the devices and follow manufacturer instructions for recall remediation.
Olympus Corporation of the Americas recalls 361 units in the US and 258 units overseas as of September 11, 2025. The recall targets the EVIS EXERA b Bronchovideoscope BF-XT190. The update adds safety instructions for using bronchoscopes with laser, argon plasma coagulation, and high-frequency therapy equipment. Patients and healthcare providers should stop using the device immediately and follow a