Class IIOngoingZ-1852-2026
Olympus Corporation Of The Americas recalls Olympus Thunderbeat II Shears w/Ultrasonic Mode
Potential for detachment of a distal tip component of the device during use.
Olympus Corporation of…PAApr 29, 2026
Recalls: Device Design
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 49–60 of 588 recalls
Class IIOngoingZ-1851-2026
Olympus Corporation Of The Americas recalls Olympus Thunderbeat II Shears w/Ultrasonic Mode
Potential for detachment of a distal tip component of the device during use.
Olympus Corporation of…PAApr 29, 2026
Class IIOngoingZ-1823-2026
Gentuity, LLC recalls Gentuity HF-OCT Imaging System Model G10-01
The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx Prime catheters.…
Gentuity, LLCMAApr 22, 2026
Class IOngoingZ-1803-2026
B Braun Medical Inc recalls B Braun Hemodialysis Bloodlines
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
B Braun Medical IncPAApr 22, 2026
Class IOngoingZ-1802-2026
B Braun Medical Inc recalls B. Braun Hemodialysis Bloodlines
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
B Braun Medical IncPAApr 22, 2026
Class IOngoingZ-1801-2026
B Braun Medical Inc recalls B. Barun Hemodialysis Bloodlines
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
B Braun Medical IncPAApr 22, 2026
Class IOngoingZ-1800-2026
B Braun Medical Inc recalls B. Braun Hemodialysis Bloodlines
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
B Braun Medical IncPAApr 22, 2026
Class IOngoingZ-1799-2026
B Braun Medical Inc recalls B. Braun Hemodialysis Bloodlines
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
B Braun Medical IncPAApr 22, 2026
Class IOngoingZ-1798-2026
B Braun Medical Inc recalls B. Braun Hemodialysis Bloodlines
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
B Braun Medical IncPAApr 22, 2026
Class IIOngoingZ-1752-2026
Medtronic MiniMed, Inc. recalls Paradigm REAL-Time Veo Insulin Pump (MMT-554
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infu…
Medtronic MiniMed, Inc…CAApr 8, 2026
Class IIOngoingZ-1751-2026
Medtronic MiniMed, Inc. recalls MiniMed 530G Insulin Pump (MMT-551
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infu…
Medtronic MiniMed, Inc…CAApr 8, 2026
Class IIOngoingZ-1750-2026
Medtronic MiniMed, Inc. recalls Paradigm REAL-Time Revel Insulin Pump (MMT-523
All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infu…
Medtronic MiniMed, Inc…CAApr 8, 2026