FDA Device · 2017

FDA Device recalls in 2017

RecallRadar indexes 2,615 FDA Device recall notices published in 2017. By classification: 51 Class I, 2,510 Class II, 54 Class III.

• VITEK¿ 2 Gram Negative Susceptibility card (AST-N204), REF 412865, 20 cards per carton.
  FDA Device · Class II · 2017-06-21 · Biomerieux
• ARROWg+ard Blue CVC Kit The ARROWg+ard Blue CVCs are intended to permit venous access to the central circulation
  FDA Device · Class II · 2017-06-21 · Arrow International
• R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG, 13MMDX40CM, 13MMDX42CM, 13MM…
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• VITEK¿ 2 Gram Positive Susceptibility card (AST-P628), REF 414534, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK 2 Gram Negative Susceptibility card (AST-GN38), REF 22331, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Positive Susceptibility card (AST-P613), REF 410027, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Positive Susceptibility card (AST-GP67), REF 22226, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• GE Healthcare lnnova IGS 540 ACT X-ray system
  FDA Device · Class II · 2017-06-21 · Ge Healthcare
• VITEK¿ 2 Gram Positive Susceptibility card (AST-P629), REF 414576, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N351), IVD, REF 421257, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N275), REF 414313, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Positive Susceptibility card (AST-P607), REF 22335, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Fem IM Nail 14mmdx48cm left, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the select…
  FDA Device · Class II · 2017-06-21 · Acumedia Manufacturers
• 1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit…
  FDA Device · Class II · 2017-06-21 · Arrow International
• VITEK¿ 2 Gram Fungal Susceptibility card (AST-YS07), IVD, REF 414967, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK 2 Gram Negative Susceptibility card (AST-GN09), REF 22008, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N230), REF 413147, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100
  FDA Device · Class II · 2017-06-21 · Creganna Medical Devices
• VITEK¿ 2 Gram Negative Susceptibility card (AST-GN66), REF 413398, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N353), IVD, REF 421297, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Positive Susceptibility card (AST-P648), IVD, REF 420857, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211, 00Z2212, 00Z2216, 00Z2217, 00Z2312
  FDA Device · Class II · 2017-06-21 · Medtronic
• VITEK¿ 2 Gram Positive Susceptibility card (AST-P597), REF 22298, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Segmental vss bowed 19x190mm, Sterile, Hip joint, metal/ceramic/polymer, semi-constrained, cemented or nonporous uncemented prosthesis- Spe…
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• Sheridan SHER-I-SLIP and SOFT-TIP Intubating Stylets are intubating stylets manufactured from galvanized carbon steel and aluminum rods tha…
  FDA Device · Class II · 2017-06-21 · Teleflex Medical
• VITEK¿ 2 Gram Positive Susceptibility card (AST-P584), REF 22252, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N238), REF 413203, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Sutures
  FDA Device · Class II · 2017-06-21 · Medtronic
• M3150 Information Center Local Database
  FDA Device · Class II · 2017-06-21 · Philips Electronics North America
• GE Healthcare Discovery NM/CT 670 CZT X-ray system
  FDA Device · Class II · 2017-06-21 · Ge Healthcare
• Infant Warmer System (IWS)
  FDA Device · Class II · 2017-06-21 · Ge Healthcare
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N245), REF 413394, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• 1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter permits…
  FDA Device · Class II · 2017-06-21 · Arrow International
• Segmental fluted stem, 18x250mm bwd, Sterile
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N194), REF 412605, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-GN75), REF 413432, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Fungal Susceptibility card (AST-YS01), REF 22108, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N330), IVD, REF 418674, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK 2 Gram Negative Susceptibility card (AST-N102), REF 22258, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Stamey Needle
  FDA Device · Class II · 2017-06-21 · Cook
• VITEK¿ 2 Gram Negative Susceptibility card (AST-GN87), REF 413943, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N279), REF 414492, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N215), REF 413065, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• USPACK-SUTURE KIT
  FDA Device · Class II · 2017-06-21 · Medtronic
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N193), REF 412604, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Fungal Susceptibility card (AST-YS05), REF 411945, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Segmental malefemale taper, 220mm, Sterile, Knee joint femorotibial meta/polymer constrained cemented prosthesis- Specific Knee, Hip and Na…
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• Fem IM Nail 16mmdx40cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• FEM IM NAIL 15MMDX30CM, FEM IM NAIL 16MMDX30CM FEM IM NAIL 14MMDX32CM FEM IM NAIL 15MMDX32CM FEM IM NAIL 16MMDX32CM FEM IM NAIL 14MMDX34CM…
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• VITEK¿ 2 Gram Negative Susceptibility card (AST-GN83), REF 413440, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• 1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Ant…
  FDA Device · Class II · 2017-06-21 · Arrow International
• VITEK¿ 2 Gram Negative Susceptibility card (AST-GN67), IVD, REF 413399, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Positive Susceptibility card (AST-P616), REF 410223, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N231), REF 413115, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N364), IVD, REF 421693, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Fem IM Nail 15mmdx50cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.…
  FDA Device · Class II · 2017-06-21 · Philips Electronics North America
• GE Healthcare Discovery Ml X-ray system
  FDA Device · Class II · 2017-06-21 · Ge Healthcare
• Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars
  FDA Device · Class II · 2017-06-21 · Applied Medical Resources
• Fem IM Nail 16mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyss…
  FDA Device · Class II · 2017-06-21 · Cook
• VITEK¿ 2 Gram Positive Susceptibility card (AST-P592), REF 22287, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N250), REF 413573, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N190), REF 412548, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N350), IVD, REF 421037, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N271), REF 414163, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK 2 Gram Positive Susceptibility card (AST-P577), REF 22218, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Positive Susceptibility card (AST-P646), IVD, REF 420144, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Positive Susceptibility card (AST-GP75), IVD, REF 415670, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N211), REF 413043, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Sutures
  FDA Device · Class II · 2017-06-21 · Medtronic
• VITEK¿ 2 Gram Positive Susceptibility card (AST-P649), IVD, REF 420858, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-XN01), REF 410025, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N237), REF 413172, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Fem IM Nail 15mmdx48cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• Fem IM Nail 16mmdx44cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N235), REF 413170, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Endoscopic Introducer/Extractor
  FDA Device · Class II · 2017-06-21 · Cook
• Segmental malefemale taper, 200mm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• SCHRITTMACHER ANGIO X3
  FDA Device · Class II · 2017-06-21 · Medtronic
• VITEK¿ 2 Gram Negative Susceptibility card (AST-GN74), REF 413941, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-P625), REF 413727, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N314), IVD, REF 417027, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Positive Susceptibility card (AST-P641), IVD, REF 418590, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Positive Susceptibility card (AST-P645), IVD, REF 419602, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N249), REF 413572, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Fem IM Nail 16mmdx38cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• Philips DigitalDiagnost 3.1.x X-Ray System
  FDA Device · Class II · 2017-06-21 · Philips Electronics North America
• VITEK¿ 2 Gram-Negative identification card (GN), IVD, REF 21341, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter permi…
  FDA Device · Class II · 2017-06-21 · Arrow International
• TIBIAL I/M NAIL 15MMDX26CM, TIBIAL I/M NAIL 15MMDX28CM TIBIAL I/M NAIL 15MMDX30CM TIBIAL I/M NAIL 14MMDX32CM TIBIAL I/M NAIL 15MMDX32CM TIB…
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N195), REF412609, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Fem IM Nail 16mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
  FDA Device · Class II · 2017-06-21 · Zimmer Biomet
• VITEK¿ 2 Gram Negative Susceptibility card (AST-N325), IVD, REF 418513, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux
• Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features
  FDA Device · Class II · 2017-06-21 · Arrow International
• VITEK¿ 2 Gram Negative Susceptibility card (AST-GN80), REF 413437, 20 cards per carton
  FDA Device · Class II · 2017-06-21 · Biomerieux

Other years

2026 (2,024) · 2025 (2,908) · 2024 (3,393) · 2023 (2,477) · 2022 (2,191) · 2021 (2,303) · 2020 (3,055) · 2019 (2,801) · 2018 (3,757) · 2017 (2,615) · 2016 (3,246) · 2015 (2,495) · 2014 (3,059) · 2013 (2,249) · 2012 (1,310)