Class IIOngoingZ-1914-2025
Stryker GmbH recalls Long Nail
Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
Stryker GmbHJun 18, 2025
2025 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,705–1,716 of 2,908 recalls
Class IOngoingZ-1869-2025
Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM LVP Blood Products Administration Set
Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
Fresenius Kabi USA, LL…MAJun 18, 2025
Class IOngoingZ-1868-2025
Zyno Medical LLC recalls Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids
Unreleased software versions were installed on distributed devices without verification or validation.
Zyno Medical LLCMAJun 18, 2025
Class IOngoingZ-1867-2025
Zyno Medical LLC recalls Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids
Unreleased software versions were installed on distributed devices without verification or validation.
Zyno Medical LLCMAJun 18, 2025
Class IOngoingZ-1866-2025
Zyno Medical LLC recalls Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids
Unreleased software versions were installed on distributed devices without verification or validation.
Zyno Medical LLCMAJun 18, 2025
Class IOngoingZ-1865-2025
Zyno Medical LLC recalls Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids
Unreleased software versions were installed on distributed devices without verification or validation.
Zyno Medical LLCMAJun 18, 2025
Class IIOngoingZ-1820-2025
GE Medical Systems, LLC recalls OEC 3D
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
GE Medical Systems, LL…WIJun 18, 2025
Class IIOngoingZ-1819-2025
GE Medical Systems, LLC recalls OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital s…
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
GE Medical Systems, LL…WIJun 18, 2025
Class IIOngoingZ-1913-2025
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Beckman Coulter, Inc.MNJun 11, 2025
Class IIOngoingZ-1911-2025
Olympus Corporation Of The Americas recalls Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared…
Olympus Corporation of…PAJun 11, 2025
Class IIOngoingZ-1910-2025
Healthmark Industries Co., Inc. recalls ChannelCheck Convenience Pack
During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation.…
Healthmark Industries…MIJun 11, 2025
Class IIOngoingZ-1909-2025
Healthmark Industries Co., Inc. recalls Pre-filled Water Syringe
During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation.…
Healthmark Industries…MIJun 11, 2025