Medical DeviceFeb 11, 2026
CleverCut Single Use 3-Lumen Sphincterotome V recall — FDA Z-1268-2026
Devices which did not undergo thermoforming could deform and lose performance.
Class IIFDA: OngoingOlympus Corporation of the Americas
February 2026 recalls — page 9
These records include useful source details for the selected month.
Medical DeviceFeb 11, 2026
Olympus Corporation of the Americas Disposable Triple Lumen Sphincterotome recall — FDA Z-1285-2026
Devices which did not undergo thermoforming could deform and lose performance.
Class IIFDA: OngoingOlympus Corporation of the Americas
Medical DeviceFeb 11, 2026
Boston Scientific *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm recall — FDA Z-1163-2026
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceFeb 11, 2026
Olympus Corporation of the Americas Single Use 3-Lumen Sphincterotome V (Distal Wire guided) recall — FDA Z-1277-2026
Devices which did not undergo thermoforming could deform and lose performance.
Class IIFDA: OngoingOlympus Corporation of the Americas
Medical DeviceFeb 11, 2026
FUJIFILM Healthcare Americas FDR Visionary Suite recall — FDA Z-1299-2026
It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to…
Class IIFDA: OngoingFUJIFILM Healthcare Americas Corporation
Medical DeviceFeb 11, 2026
Changchun Wancheng Bio-Electron Co Vivoo Protein Test recall — FDA Z-1265-2026
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…
Class IIFDA: OngoingChangchun Wancheng Bio-Electron Co., Ltd.
Medical DeviceFeb 11, 2026
Vortex Surgical 1. 23GA Laser Probe Curved Cat No recall — FDA Z-1245-2026
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…
Class IIFDA: OngoingVortex Surgical Inc.
Medical DeviceFeb 11, 2026
Olympus Corporation of the Americas Single Use 3-Lumen Sphincterotome V recall — FDA Z-1275-2026
Devices which did not undergo thermoforming could deform and lose performance.
Class IIFDA: OngoingOlympus Corporation of the Americas
Medical DeviceFeb 11, 2026
Focalyx Fusion recall — FDA Z-1243-2026
Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may…
Class IIFDA: OngoingFocalyx Technologies, LLC.
Medical DeviceFeb 11, 2026
Olympus Corporation of the Americas Single Use 3-Lumen Sphincterotome V (Distal Wire guided) recall — FDA Z-1278-2026
Devices which did not undergo thermoforming could deform and lose performance.
Class IIFDA: OngoingOlympus Corporation of the Americas
Medical DeviceFeb 11, 2026
Olympus Corporation of the Americas Disposable Triple Lumen Sphincterotome recall — FDA Z-1286-2026
Devices which did not undergo thermoforming could deform and lose performance.
Class IIFDA: OngoingOlympus Corporation of the Americas
Medical DeviceFeb 11, 2026
Boston Scientific AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm recall — FDA Z-1158-2026
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceFeb 11, 2026
Olympus Corporation of the Americas Single Use 3-Lumen Sphincterotome V (Distal Wire guided) recall — FDA Z-1297-2026
Devices which did not undergo thermoforming could deform and lose performance.
Class IIFDA: OngoingOlympus Corporation of the Americas
Medical DeviceFeb 11, 2026
Olympus Corporation of the Americas Disposable Triple Lumen Sphincterotome recall — FDA Z-1288-2026
Devices which did not undergo thermoforming could deform and lose performance.
Class IIFDA: OngoingOlympus Corporation of the Americas
Medical DeviceFeb 11, 2026
Boston Scientific HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm recall — FDA Z-1161-2026
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to…
Class IFDA: OngoingBoston Scientific Corporation
Medical DeviceFeb 11, 2026
Olympus Corporation of the Americas Disposable Triple Lumen Sphincterotome recall — FDA Z-1270-2026
Devices which did not undergo thermoforming could deform and lose performance.
Class IIFDA: OngoingOlympus Corporation of the Americas
Medical DeviceFeb 11, 2026
Fujirebio Diagnostics Lumipulse G pTau 217 Plasma Calibrators recall — FDA Z-1303-2026
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to…
Class IIFDA: OngoingFujirebio Diagnostics, Inc.
Medical DeviceFeb 11, 2026
Molift Mover 205 recall — FDA Z-1308-2026
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became…
Class IIFDA: OngoingETAC A/S
Medical DeviceFeb 11, 2026
Olympus Corporation of the Americas Single Use 3-Lumen Sphincterotome V recall — FDA Z-1296-2026
Devices which did not undergo thermoforming could deform and lose performance.
Class IIFDA: OngoingOlympus Corporation of the Americas
Medical DeviceFeb 11, 2026
Olympus Corporation of the Americas Disposable Triple Lumen Sphincterotome recall — FDA Z-1289-2026
Devices which did not undergo thermoforming could deform and lose performance.
Class IIFDA: OngoingOlympus Corporation of the Americas
Medical DeviceFeb 11, 2026
Changchun Wancheng Bio-Electron Co Exploro Highly Sensitive Male Fertility / Sperm recall — FDA Z-1263-2026
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…
Class IIFDA: OngoingChangchun Wancheng Bio-Electron Co., Ltd.
Medical DeviceFeb 11, 2026
Biomerieux VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o recall — FDA Z-1236-2026
Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with…
Class IIFDA: OngoingBiomerieux Inc.
Medical DeviceFeb 11, 2026
Changchun Wancheng Bio-Electron Co Male Fertility Sperm Test for Home Use (Cassette) recall — FDA Z-1262-2026
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…
Class IIFDA: OngoingChangchun Wancheng Bio-Electron Co., Ltd.
Medical DeviceFeb 11, 2026
Olympus Corporation of the Americas Single Use 3-Lumen Sphincterotome V recall — FDA Z-1273-2026
Devices which did not undergo thermoforming could deform and lose performance.
Class IIFDA: OngoingOlympus Corporation of the Americas
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.