fda regulated Recalls

1,264 recalls tagged with “fda regulated”.

Health & Personal Care
HIGH
FDA DEVICE

UIH Technologies Recalls 11 uCT 760 MD CT Scanners for Cover Interference Risk (2025)

UIH Technologies recalled 11 units of the uCT 760 MD Computed Tomography X-ray System. Third-party outer covers can become trapped between the patient table and gantry, causing mechanical interference during table movement. Hospitals and patients should stop using the device immediately and await manufacturer instructions.

UIH Technologies
Third-party outer
Read more
Health & Personal Care
HIGH
FDA DRUG

Major Pharmaceuticals Chlorpromazine Hydrochloride 100 mg Recall 2025 — 866 Blister Packs Nationwide

Major Pharmaceuticals recalled 866 Chlorpromazine Hydrochloride 100 mg tablets distributed nationwide after CGMP deviations allowed N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. The impurity detected raises safety concerns for ongoing use. Stop using the product immediately and contact Harvard Drug Group LLC dba Major Pharmaceuticals or Rugby Laboratories for guidance and,

Major Pharmaceuticals
CGMP Deviations:
Read more
Health & Personal Care
HIGH
FDA DRUG

Major Pharmaceuticals Chlorpromazine 25 mg Tablets Recalled for Nitrosamine Contamination (1256 Bls,

Major Pharmaceuticals recalled 1,256 blister packs of Chlorpromazine Hydrochloride tablets, 25 mg, sold nationwide in the United States. A CGMP deviation led to the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake. Healthcare providers and patients should stop using the product and contact Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories for next-步

Chlorpromazine Hydrochloride
CGMP Deviations:
Read more
Health & Personal Care
HIGH
FDA DEVICE

GE HealthCare Recalls 102 Dual-Head Gamma Cameras for Cardiac Imaging (2025)

GE HealthCare recalled 102 dual-head gamma cameras used for cardiac imaging worldwide after finding that some systems past the End of Guaranteed Service could be moved without adequate detector support. This could place excessive stress on detector mounting mechanisms and may cause a detector to fall, posing life-threatening risk. Hospitals and healthcare providers should stop using the devices IM

GE HealthCare
GE HealthCare
Read more
Health & Personal Care
HIGH
FDA DEVICE

GE HealthCare Millenium MPR Gamma Camera Recalled for 292 Units Worldwide in 2025

GE HealthCare recalled 292 Millenium MPR dual-head gamma cameras worldwide after discovering some units past End of Guaranteed Service may have been transported without adequate detector support. This can place excessive stress on detector mounting and could result in a detector fall with life-threatening injury. Healthcare facilities should stop using the devices immediately and follow recall PIN

GE HealthCare
GE HealthCare
Read more
Health & Personal Care
HIGH
FDA DRUG

Major Pharmaceuticals Chlorpromazine Hydrochloride 200 mg Recall Involves 1,394 Blister Packs (2025)

Major Pharmaceuticals recalled 1,394 blister packs of Chlorpromazine Hydrochloride Tablets, 200 mg, distributed nationwide. The recall cites CGMP deviations with the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. Healthcare providers and patients are urged to stop using the product and await guidance from Major Pharmaceuticals and Rugby Laboratories.

Chlorpromazine Hydrochloride
CGMP Deviations:
Read more
Health & Personal Care
HIGH
FDA DRUG

Unique Pharmaceuticals Cetirizine Hydrochloride 10 mg Tablets Recalled Nationwide in 2025

9,936 bottles of Cetirizine Hydrochloride Tablets USP 10 mg were recalled nationwide in the United States. Manufactured by Unique Pharmaceuticals Labs and distributed by Rising Pharma Holdings, the lot carries imprint with the wrong ID. Stop using the product immediately and contact the manufacturer or your healthcare provider for guidance.

Cetirizine Hydrochloride
Tablet/Capsules Imprinted
Read more
Health & Personal Care
HIGH
FDA DEVICE

GE Medical Systems Israel Recalls Elscint SPX4 Gamma Camera for Cardiac Imaging

GE Medical Systems Israel is recalling 45 units of the Elscint SPX4 dual-head gamma camera worldwide. The recall cites a risk from transporting or relocating systems past End of Guaranteed Service without adequate detector support. Hospitals and clinics should stop using the device immediately and follow manufacturer instructions.

GE Medical Systems Israel
GE HealthCare
Read more
Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-P190 Bronchoscope Recall Updated for 2025 IFU Guidance

Olympus recalls 3,046 BF-P190 bronchovideoscopes sold nationwide in the US and 2,414 overseas. The recall centers on updated IFU guidance to clarify safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. Clinicians and facilities should stop using the device immediately and follow Olympus recall instructions.

Olympus
Additional IFU
Read more
Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Recall: Preconnect with TENACIO Pump with InhibiZone Affects 172 Units Worldwide

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.

Boston Scientific
The potential
Read more
Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-H1100 Bronchovideoscope Recall 1,867 Units Overseas in 2025

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
Additional IFU
Read more
Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-XT190 Bronchovideoscope Recall for IFU Updates Over Laser and HF Therapy Use

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

Olympus Corporation of the Americas
Additional IFU
Read more
Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific LGX Preconnect with TENACIO Pump Recalled for Inflation/Deflation Issues (2025)

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.

Boston Scientific
The potential
Read more
Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific TENACIO Pump Recall 2025 for Inflation Deflation Issues

Boston Scientific recalled the TENACIO Pump without InhibiZone (UPN 72404420) worldwide, including the US and Canada. The device may experience inflation and/or deflation performance issues. Patients and healthcare providers should stop using the device immediately and follow the manufacturer's recall instructions.

Boston Scientific
The potential
Read more
Health & Personal Care
HIGH
FDA DEVICE

Olympus EVIS EXERA II BF-P180 Bronchovideoscope Recalled; 3,250 Units Affected Worldwide (2025)

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.

Olympus Corporation of the Americas
Additional IFU
Read more
Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-H190 Bronchovideoscope Recall Expanded for IFU Updates in 2025

Olympus Corporation of the Americas recalls 5,221 units sold in the U.S. and 4,321 units overseas. The recall covers the EVIS EXERA III BRONCHOVIDEOSCOPE BF-H190. It flags updated instructions for safe use with laser, argon plasma coagulation and high-frequency therapy equipment. Patients and healthcare providers should stop using the device immediately and follow recall instructions.

Olympus Corporation of the Americas
Additional IFU
Read more
Health & Personal Care
HIGH
FDA DEVICE

Olympus BF-Q180-AC Bronchoscope Recall Due to Safety Issues - Stop Using Now

Olympus recalled 395 EVIS EXERA II bronchoscopes after updates revealed safety concerns. The bronchoscope's instructions for use with laser and coagulation equipment lacked clarity, posing high risks during procedures. Patients and healthcare providers must stop using this device and follow recall instructions immediately.

Olympus Corporation of the Americas
Additional IFU
Read more