February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These ins
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Descriptio
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test
Hazard: 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.
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls Vivoo Vaginal pH Test
Hazard: 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.
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls Vivoo Protein Test
Hazard: 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.
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls Vivoo pH Test
Hazard: 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.
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Hazard: 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.
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls Male Fertility Sperm Test for Home Use (Cassette)
Hazard: 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.
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls S. Typhi/Para Typhi A Antigen
Hazard: 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.
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls Menopause Test Cassette (Urine)
Hazard: 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.
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls LH One Step Ovulation Test Device (Urine)
Hazard: 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.
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI
Hazard: 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.
February 11, 2026Medical DevicesFDA
Changchun Wancheng Bio-Electron Co., Ltd. recalls LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in
Hazard: 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.
February 11, 2026Medical DevicesFDA
Vortex Surgical Inc. recalls Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
Hazard: 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.
February 11, 2026Medical DevicesFDA
Vortex Surgical Inc. recalls Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
Hazard: 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.
February 11, 2026Medical DevicesFDA
Vortex Surgical Inc. recalls Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
Hazard: XXX
February 11, 2026Medical DevicesFDA
Vortex Surgical Inc. recalls Rumex Disposable Diamond Dusted ILM Elevator, 12-7523
Hazard: 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.
February 11, 2026Medical DevicesFDA
Vortex Surgical Inc. recalls Vortex Surgical I2 Injection Kit, VS0500
Hazard: 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.
February 11, 2026Medical DevicesFDA
Vortex Surgical Inc. recalls Tecfen Retractable Membrane Polisher, QTPR1267-23
Hazard: 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.