Class IOngoingZ-2600-2026
Abiomed, Inc. recalls Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Co…
Potential for thrombus formation during prolonged use of the introducer.
Abiomed, Inc.MAJul 1, 2026
Recalls: Under Investigation by firm
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 13–24 of 1,121 recalls
Class IOngoingZ-2599-2026
Abiomed, Inc. recalls Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product Co…
Potential for thrombus formation during prolonged use of the introducer.
Abiomed, Inc.MAJul 1, 2026
Class IIOngoingZ-2577-2026
Medtronic Perfusion Systems recalls Octopus 4 Tissue Stabilizer
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned.…
Medtronic Perfusion Sy…MNJul 1, 2026
Class IIOngoingZ-2576-2026
Medtronic Perfusion Systems recalls Octopus Evolution AS Tissue Stabilizer
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned.…
Medtronic Perfusion Sy…MNJul 1, 2026
Class IIOngoingZ-2575-2026
Medtronic Perfusion Systems recalls Octopus Evolution Tissue Stabilizer
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned.…
Medtronic Perfusion Sy…MNJul 1, 2026
Class IIOngoingZ-2573-2026
SURGIFY MEDICAL OY recalls Surgify Halo
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
SURGIFY MEDICAL OYJul 1, 2026
Class IIOngoingZ-2572-2026
SURGIFY MEDICAL OY recalls Surgify Halo
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
SURGIFY MEDICAL OYJul 1, 2026
Class IIOngoingZ-2571-2026
SURGIFY MEDICAL OY recalls Surgify Halo
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
SURGIFY MEDICAL OYJul 1, 2026
Class IIOngoingZ-2570-2026
SURGIFY MEDICAL OY recalls Surgify Halo
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
SURGIFY MEDICAL OYJul 1, 2026
Class IIOngoingZ-2569-2026
SURGIFY MEDICAL OY recalls Surgify Halo
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
SURGIFY MEDICAL OYJul 1, 2026
Class IIOngoingZ-2568-2026
SURGIFY MEDICAL OY recalls Surgify Halo
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
SURGIFY MEDICAL OYJul 1, 2026
Class IIOngoingZ-2567-2026
SURGIFY MEDICAL OY recalls Surgify Halo
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
SURGIFY MEDICAL OYJul 1, 2026