repair available Recalls

239 recalls tagged with “repair available”.

Health & Personal Care
HIGH
FDA DEVICE

Alcon CONSTELLATION Ultravit 10K & HyperVit 20K Recall for 28,323 Units (2025)

Alcon recalls 28,323 CONSTELLATION Ultravit 10K and CONSTELLATION HyperVit 20K devices used in hospitals worldwide. The recall lists an unspecified hazard. Hospitals should stop using the devices immediately and follow the manufacturer’s instructions. Access the FDA recall notice for details.

Alcon
XXX
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Health & Personal Care
HIGH
FDA DEVICE

UIH Technologies uEXPLORER MD PET/CT Recall for 2 Units in 2025

UIH Technologies recalled 2 uEXPLORER MD PET/CT systems after finding third-party outer covers can trap between the patient table and gantry. The interference can occur during table movement. Hospitals and healthcare facilities should stop using the devices and await instructions from UIH Technologies LLC.

UIH Technologies
Third-party outer
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Health & Personal Care
HIGH
FDA DEVICE

UIH Technologies Recalls 2 uCT ATLAS MD CT X-ray Systems for Mechanical Interference Risk (2025)

UIH Technologies LLC recalled 2 units of the uCT ATLAS MD CT X-ray System sold to U.S. health care providers after reports of potential mechanical interference during table movement. The issue involves third-party outer covers that can become trapped between the patient table and gantry. Hospitals should stop using the devices immediately and follow recall instructions from UIH Technologies LLC.

UIH Technologies
Third-party outer
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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
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Health & Personal Care
HIGH
FDA DEVICE

UIH Technologies uCT 780 MD CT Scanner Recalled for Cover Interference (2025)

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
Third-party outer
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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
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Health & Personal Care
LOW
FDA DEVICE

Philips S4-1 Ultrasound Transducer Recall: 41 Units Nationwide in 2025

Philips Ultrasound, Inc. recalled 41 S4-1 Ultrasound Transducers distributed nationwide in the United States. The recall is to provide clarification and labeling to define the useful life of ultrasound transducers in the field. Healthcare providers should stop using these devices immediately and follow the recall instructions from Philips or their facility.

Philips Ultrasound
To provide
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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems LKRA40G Radiology Pack Recalled Over Unvalidated Re-sterilization (HIGH)

American Contract Systems recalled 32,433 radiology packs after a nonconformance during EO gas injection. The items were re-gassed and not validated for multiple sterilization cycles. The recall is active as of 2025-10-22. US distribution included SD, IA, MN, WA, IL. Health risks prompt immediate removal from use.

American Contract Systems
Identified products
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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems Recalls 32,433 Medical Convenience Kits Over Re-Gassing Risk (2025)

American Contract Systems recalled 32,433 medical convenience kits sold through multiple retailers nationwide. The devices were re-gassed after a nonconformance in the Ethylene Oxide gas injection process and have not been validated for exposure to multiple sterilization cycles. Healthcare providers and patients should stop using these products immediately and follow the manufacturer's recall.

American Contract Systems
Identified products
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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems High-Rire Recall: 32,433 Medical Convenience Kits Recalled for Re-GassedEO

American Contract Systems recalled 32,433 medical convenience kits nationwide after finding re-gassed devices from EO sterilization. The recall affects five product lines with UDI-DI codes and Lot numbers. The re-gassing process has not been validated for multiple sterilization cycles, calling into question product safety and effectiveness. Health providers and patients should stop using these kit

American Contract Systems
Identified products
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Health & Personal Care
HIGH
FDA DEVICE

American Contract Systems High-Index Medical Kits Recalled for Re-Gassing After EO Sterilization Non

American Contract Systems recalled 32,433 medical convenience kits nationwide in the United States after re-gassing sterilization cycles. The recall covers multiple packs including HEART PACK and PACEMAKER PACK with 2025 recall date. The safety issue centers on EO gasset validation failures after a nonconformance during initial gas injection. Stop using immediately and follow recall instructions.

American Contract Systems
Identified products
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Health & Personal Care
HIGH
FDA DEVICE

Philips Allura Xper FD20/20 Recall Affects 75 Systems Worldwide for Internal Component Deterioration

Philips Medical Systems Nederland B.V. recalls 75 Allura Xper FD20/20 imaging systems due to potential deterioration of the CMOS battery, hard drive and power supply. Motorized movements could become unavailable while X-ray imaging remains functional. Operators should stop using affected units and follow manufacturer instructions.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Systems may
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Health & Personal Care
HIGH
FDA DEVICE

Philips Medical Systems Nederland B.V. Recalled 98 Imaging Systems for CMOS Battery, HDD, PSU Deteri

Philips Medical Systems Nederland B.V. recalls 98 imaging systems worldwide after reports of component deterioration. Systems may lose motorized movements due to CMOS battery, hard disk drive, or power supply deterioration. Imaging remains available. Stop using the device and follow manufacturer instructions.

Philips Medical Systems Nederland B.V.
Systems may
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