Medical Devices Recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
27,372 recalls · Page 1 of 548
FDA Devices Moderate Feb 11, 2026
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0…
Vortex Surgical Inc.
FDA Devices Moderate Feb 11, 2026
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lyt…
Beckman Coulter, Inc.
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been designed to …
Olympus Corporation of the Americas
FDA Devices Moderate Feb 11, 2026
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These instruments have been designed t…
Olympus Corporation of the Americas
FDA Devices Moderate Feb 11, 2026
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau …
Fujirebio Diagnostics, Inc.
FDA Devices Moderate Feb 11, 2026
Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 Product Desc…
ETAC A/S
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: These instrumen…
Olympus Corporation of the Americas
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: These instrumen…
Olympus Corporation of the Americas
FDA Devices Moderate Feb 11, 2026
Male Fertility Sperm Test for Home Use (Cassette)
Changchun Wancheng Bio-Electron Co., Ltd.
FDA Devices Moderate Feb 11, 2026
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam (mev01n) o I…
Biomerieux Inc
FDA Devices Moderate Feb 11, 2026
Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
Changchun Wancheng Bio-Electron Co., Ltd.
FDA Devices Moderate Feb 11, 2026
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0730 Product Description: These instruments have been designed t…
Olympus Corporation of the Americas
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to …
Olympus Corporation of the Americas
FDA Devices Moderate Feb 11, 2026
Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, (5) M14150, (6) M1402-01, (7)…
ETAC A/S
FDA Devices Moderate Feb 11, 2026
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse …
Fujirebio Diagnostics, Inc.
FDA Devices Moderate Feb 11, 2026
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These instruments have been designed t…
Olympus Corporation of the Americas
FDA Devices Critical Feb 11, 2026
HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Material Number (UPN): M00553520;
Boston Scientific Corporation
FDA Devices Moderate Feb 11, 2026
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0720 Product Description: These instruments have been designed t…
Olympus Corporation of the Americas
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Descrip…
Olympus Corporation of the Americas
FDA Devices Critical Feb 11, 2026
AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Material Number (UPN): M00553660;
Boston Scientific Corporation
FDA Devices Moderate Feb 11, 2026
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have been designed t…
Olympus Corporation of the Americas
FDA Devices Moderate Feb 11, 2026
PRIMSAFLEX M100 SET, Product Code 106697; Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Version: N/A Product Descrip…
Olympus Corporation of the Americas
FDA Devices Moderate Feb 11, 2026
Focalyx Fusion
Focalyx Technologies, LLC.
FDA Devices Moderate Feb 11, 2026
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product Description: These instrumen…
Olympus Corporation of the Americas
FDA Devices Moderate Feb 11, 2026
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC
FDA Devices Moderate Feb 11, 2026
Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Ca…
Vortex Surgical Inc.
FDA Devices Moderate Feb 11, 2026
Vivoo Protein Test
Changchun Wancheng Bio-Electron Co., Ltd.
FDA Devices Moderate Feb 11, 2026
FDR Visionary Suite; Model Number: CH-200; Version: (1) 566-16130-23, (2) 566-16130-31, (3)
FUJIFILM Healthcare Americas Corporation
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software Version: N/A Product Descri…
Olympus Corporation of the Americas
FDA Devices Critical Feb 11, 2026
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; Material Number (UPN): M00553560;
Boston Scientific Corporation
FDA Devices Moderate Feb 11, 2026
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC
FDA Devices Moderate Feb 11, 2026
Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
Vortex Surgical Inc.
FDA Devices Moderate Feb 11, 2026
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These instruments have been designed t…
Olympus Corporation of the Americas
FDA Devices Moderate Feb 11, 2026
Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product Descri…
Olympus Corporation of the Americas
FDA Devices Moderate Feb 11, 2026
Vortex Surgical I2 Injection Kit, VS0500
Vortex Surgical Inc.
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A Product Descript…
Olympus Corporation of the Americas
FDA Devices Moderate Feb 11, 2026
Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
Vortex Surgical Inc.
FDA Devices Moderate Feb 11, 2026
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product Description: These instrumen…
Olympus Corporation of the Americas
FDA Devices Moderate Feb 11, 2026
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC
FDA Devices Moderate Feb 11, 2026
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Siemens Medical Solutions USA, Inc
FDA Devices Moderate Feb 11, 2026
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
Encore Medical, LP
FDA Devices Moderate Feb 11, 2026
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; …
Changchun Wancheng Bio-Electron Co., Ltd.
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Version: N/A Product Descrip…
Olympus Corporation of the Americas
FDA Devices Moderate Feb 11, 2026
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Siemens Medical Solutions USA, Inc
FDA Devices Critical Feb 11, 2026
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680;
Boston Scientific Corporation
FDA Devices Moderate Feb 11, 2026
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product …
Olympus Corporation of the Americas
FDA Devices Moderate Feb 11, 2026
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Version: N/A Product Descrip…
Olympus Corporation of the Americas