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1,784 recalls
High RiskFDA
Cook Medical Incorporated
Zilver 518 Biliary Stent 5mm x 30mm, Catalog Number: ZIB5-125-5.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are inten...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-80-5.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intend...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-80-12.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are inte...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-125-14.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are int...
Medical Implants·9,384 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-125-14.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are int...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Dt Medtech, Llc
DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components are prostheses for a mobile bearing ankle joint.
Medical Implants·1 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-125-5.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are inten...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-125-5.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are inten...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-80-5.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intend...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-125-14.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are int...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are inten...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-125-14.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are int...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-80-12.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are inte...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-80-12.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are inte...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 518 Biliary Stent 4mm x 40mm, Catalog Number: ZIB5-125-4.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are inten...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-125-5.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are inten...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 518 Biliary Stent 4mm x 20mm, Catalog Number: ZIB5-125-4.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are intende...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-125-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are inten...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-80-14.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are inte...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Dt Medtech, Llc
DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components are prostheses for a mobile bearing ankle joint.
Medical Implants·54 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 518 Biliary Stent 4mm x 80mm, Catalog Number: ZIB5-125-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are inten...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intend...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-80-12.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are inte...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-125-12.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are int...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intend...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 518 Biliary Stent 4mm x 60mm, Catalog Number: ZIB5-125-4.0-60 Product Usage: The Zilver 518 and 635 Biliary Stents are inten...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 518 Biliary Stent 5mm x 20mm, Catalog Number: ZIB5-125-5.0-20 Product Usage: The Zilver 518 and 635 Biliary Stents are inten...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-125-12.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are int...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 518 Biliary Stent 5mm x 40mm, Catalog Number: ZIB5-125-5.0-40 Product Usage: The Zilver 518 and 635 Biliary Stents are inten...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Cook Medical Incorporated
Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-125-4.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are inten...
Medical Implants·9,834 affected·Sep 25, 2018
High RiskFDA
Zimmer Biomet, Inc.
StageOne Hip, Models 431207 & 431209Usage: Product Usage: The single-use cement spacer molds are sterile disposables made of medica...
Medical Implants·72 affected·Sep 21, 2018
High RiskFDA
Arthrex, Inc.
3.2mm Proximal Reamer/Cannulated Drill provided as part of the Fibulock Fibular Nail System Pack. FibuLock Nail Procedure Pack: Contains...
Medical Implants·832 affected·Sep 13, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09P...
Medical Implants·107 affected·Sep 6, 2018
High RiskFDA
Cordis Corporation
Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, ...
Medical Implants·162 affected·Sep 5, 2018
CriticalFDA
Alcon Research, Ltd.
CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.
Medical Implants·30,561 affected·Aug 28, 2018
CriticalFDA
Alcon Research, Ltd.
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754001. For ophthalmic use.
Medical Implants·14,264 affected·Aug 28, 2018
High RiskFDA
Coltene Whaledent Inc
ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth f...
Medical Implants·30 affected·Aug 21, 2018
High RiskFDA
Biomerieux, Inc.
VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobial...
Medical Implants·10,919 affected·Aug 13, 2018
High RiskFDA
Biomerieux, Inc.
VITEK(R) 2 AST-P640, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobial...
Medical Implants·2,538 affected·Aug 13, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part ...
Medical Implants·22 affected·Aug 8, 2018
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Impl...
Medical Implants·158 affected·Aug 7, 2018
CriticalFDA
Endologix
ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF: BA22-120/I20-40, BA22-100/I20-...
Medical Implants·45,304 affected·Jul 31, 2018
CriticalFDA
Endologix
ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF: BEA22-120/I20-40, BEA22-100/I20...
Medical Implants·13,178 affected·Jul 31, 2018
High RiskFDA
Trilliant Surgical, Llc
Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Disco Subtalar Implant System, Model 112...
Medical Implants·4 affected·Jul 19, 2018
High RiskFDA
Trilliant Surgical, Llc
Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-...
Medical Implants·4 affected·Jul 19, 2018
High RiskFDA
Sorin Crm Sas
Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Medical Implants·16 affected·Jul 9, 2018
High RiskFDA
Sorin Crm Sas
Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Medical Implants·10 affected·Jul 9, 2018
High RiskFDA
Abbott Vascular
PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with intervention...
Medical Implants·26 affected·Jul 3, 2018