Class IIOngoingZ-0306-2026
Alcon Research LLC recalls Brand Name: Alcon Laboratories
Due to incomplete seals in the pouch which provide the sterile barrier.
Alcon Research LLCTXNov 5, 2025
2025 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 661–672 of 2,908 recalls
Class IIOngoingZ-0305-2026
Alcon Research LLC recalls Brand Name: Alcon Laboratories
Due to incomplete seals in the pouch which provide the sterile barrier.
Alcon Research LLCTXNov 5, 2025
Class IIOngoingZ-0304-2026
Alcon Research LLC recalls Brand Name: Alcon Laboratories
Due to incomplete seals in the pouch which provide the sterile barrier.
Alcon Research LLCTXNov 5, 2025
Class IOngoingZ-0188-2026
BALT USA, LLC recalls Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Cata…
Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen.
BALT USA, LLCCANov 5, 2025
Class IOngoingZ-0164-2026
IMPRIS Imaging Inc recalls IMRIS Operating Suite
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite.…
IMPRIS Imaging IncMNNov 5, 2025
Class IOngoingZ-0163-2026
IMPRIS Imaging Inc recalls IMRIS Operating Suite
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite.…
IMPRIS Imaging IncMNNov 5, 2025
Class IOngoingZ-0162-2026
IMPRIS Imaging Inc recalls IMRIS Operating Suite
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite.…
IMPRIS Imaging IncMNNov 5, 2025
Class IOngoingZ-0161-2026
IMPRIS Imaging Inc recalls IMRIS Operating Suite
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite.…
IMPRIS Imaging IncMNNov 5, 2025
Class IIOngoingZ-0303-2026
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Starcam/Camstar
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support.…
GE MEDICAL SYSTEMS ISR…Oct 29, 2025
Class IIOngoingZ-0302-2026
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Sopha Medical Vision (SMV) DSXi/DST-XLi
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support.…
GE MEDICAL SYSTEMS ISR…Oct 29, 2025
Class IIOngoingZ-0301-2026
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Optima NX
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support.…
GE MEDICAL SYSTEMS ISR…Oct 29, 2025
Class IIOngoingZ-0300-2026
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Millenium MPS
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support.…
GE MEDICAL SYSTEMS ISR…Oct 29, 2025