Medical device recalls
38684 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 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.
- 2026-02-11FDA-DeviceChangchun Wancheng Bio-Electron Co., Ltd.Class IIStop using Changchun Wancheng typhoid 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 Menopause Test Cassette
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 LH One Step Ovulation Test
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 these urine 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 recalled UTI 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-DeviceVortex Surgical Inc.Class IIStop using Vortex Surgical scleral markers
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
- 2026-02-11FDA-DeviceVortex Surgical Inc.Class IIStop using Vortex Surgical 25GA and 27GA Backflush needles
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
- 2026-02-11FDA-DeviceVortex Surgical Inc.Class IIVortex Surgical TID Pharos Illuminated Depressor, VS0801B
XXX
- 2026-02-11FDA-DeviceVortex Surgical Inc.Class IIStop using Vortex Surgical Rumex ILM Elevator
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
- 2026-02-11FDA-DeviceVortex Surgical Inc.Class IIStop using Vortex Surgical I2 Injection Kit
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
- 2026-02-11FDA-DeviceVortex Surgical Inc.Class IIStop using Vortex Surgical Tecfen Polisher lot 2411013
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Get notified about new device recalls
Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.
Get the Sunday Brief