Medical device recalls
38845 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus KD-V411M-1530 sphincterotome
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus sphincterotome model KD-V411M-1520
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus KD-401Q-0730 sphincterotomes
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus sphincterotome model KD-401Q-0720
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus KD-401Q-0330 sphincterotomes
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus KD-411Q-0730 sphincterotome
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus sphincterotome model KD-411Q-0720
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus sphincterotome model KD-VC433Q-0730
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus sphincterotome model KD-VC433Q-0720
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IICheck Olympus sphincterotome model KD-VC412Q-0215
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus sphincterotome model KD-VC411Q-0330
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IICheck Olympus sphincterotome devices for deformation
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus sphincterotome model KD-VC411Q-0730
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using affected Olympus sphincterotome devices
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus sphincterotome model KD-VC431Q-0730
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus sphincterotome model KD-V431M-0730
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus sphincterotome model KD-V431M-0720
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus sphincterotome model KD-V411M-0730
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus sphincterotome model KD-V411M-0725
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus sphincterotome model KD-V411M-0720
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus sphincterotome devices
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus sphincterotome KD-431Q-0720
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus Sphincterotome V model KD-VC431Q-0720
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceOlympus Corporation of the AmericasClass IIStop using Olympus CleverCut sphincterotome devices
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceChangchun Wancheng Bio-Electron Co., Ltd.Class IIStop using Vivoo test strips
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- 2026-02-11FDA-DeviceChangchun Wancheng Bio-Electron Co., Ltd.Class IIStop using Vivoo Vaginal pH Test strips
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- 2026-02-11FDA-DeviceChangchun Wancheng Bio-Electron Co., Ltd.Class IIStop using Vivoo Protein Test strips
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- 2026-02-11FDA-DeviceChangchun Wancheng Bio-Electron Co., Ltd.Class IIStop using Vivoo pH Test strips
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- 2026-02-11FDA-DeviceChangchun Wancheng Bio-Electron Co., Ltd.Class IIStop using Exploro fertility test strips
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- 2026-02-11FDA-DeviceChangchun Wancheng Bio-Electron Co., Ltd.Class IIStop using Changchun Wancheng sperm test kit
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
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