Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Atrium Medical Corporation
Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100
Medical Devices·1,170 affected·May 7, 2015
High RiskFDA
Roche Diagnostics Operations, Inc.
LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test in intended for the quantitative determination of low...
Medical Devices·6,255 affected·May 7, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc
The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electrolytes, metabolites and CO-oximetry in...
Medical Devices·2,713 affected·May 6, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
syngo Workflow SLR; The information system syngo Workflow SLR is a digital radiology information system (RIS) with integrated modules for...
Medical Devices·131 affected·May 6, 2015
High RiskFDA
Terumo Cardiovascular Systems Corp
Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary ...
Medical Devices·163 affected·May 6, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, MEVATRON M2/PRIMUS Mid-Energy, ARTISTE; intended...
Medical Devices·158 affected·May 5, 2015
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103-001 and Articulated Arm Camera, 7700-103-001U Product ...
Medical Devices·72 affected·May 4, 2015
High RiskFDA
Smiths Medical Asd Inc
Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX ...
Medical Devices·6,000 affected·May 4, 2015
High RiskFDA
Ge Healthcare
GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
Medical Devices·110 affected·May 4, 2015
CriticalFDA
Synovis Surgical Innovations, Inc.
Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1x6cm, product code 1504026, 0.8x8cm, product cod...
Medical Devices·3,974 affected·May 2, 2015
High RiskFDA
Integra Lifesciences Corp. D.b.a. Integra Pain Management
Integra¿ Long Epidural Steroid Injection Needle (Tuohy Needle), 20 gauge x 5 inch. Plastic Hub, Metal Stylet, calibrations (10BX). Integ...
Medical Devices·123 affected·May 1, 2015
High RiskFDA
Biomet, Inc.
Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to...
Medical Devices·19 affected·May 1, 2015
High RiskFDA
Terumo Cardiovascular Systems Corporation
Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on t...
Medical Devices·1,713 affected·May 1, 2015
High RiskFDA
Terumo Cardiovascular Systems Corporation
100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on t...
Medical Devices·1,713 affected·May 1, 2015
High RiskFDA
Ferno-washington Inc
Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport.
Medical Devices·26 affected·May 1, 2015
High RiskFDA
Smith & Nephew, Inc.
ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.
Medical Devices·202,279 affected·Apr 30, 2015
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
EasyLink Data Management System; a clinical data management system that assists medical laboratory professionals with preanalytic and pos...
Medical Devices·1,355 affected·Apr 29, 2015
High RiskFDA
Centurion Medical Products Corporation
Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY ENDOSCOPY TRAY MIN...
Medical Devices·483 affected·Apr 29, 2015
High RiskFDA
Covidien Llc
VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
Medical Devices·1,661 affected·Apr 28, 2015
High RiskFDA
Fresenius Medical Care Holdings, Inc.
CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
Medical Devices·22,640,288 affected·Apr 27, 2015
High RiskFDA
Sheffield Pharmaceuticals, Llc
Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.
Medical Devices·37,636 affected·Apr 27, 2015
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with ...
Medical Devices·1,420 affected·Apr 24, 2015
High RiskFDA
Philips Medical Systems, Inc.
Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professiona...
Medical Devices·4 affected·Apr 23, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
D&C/Cysto Pack, Kit number PSS3257, PSS3257(A, and PSS3257(B convenience custom kits used for general surgery in hospital operating room
Medical Devices·615 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom ki...
Medical Devices·1,124 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
C-Birth Pack, Kit part number AMS2037 and AMS2037(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·48 affected·Apr 22, 2015
High RiskFDA
Lifeline Systems, Incorporated
Philips GoSafe Communicator 7000L Personal emergency response system.
Medical Devices·3,189 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Open Procedure Pack II, Kit number RMS1740(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·145 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Minor Arthroscopy Pack, Kit number 002649-14 and 002649-15 convenience custom kits used for general surgery in hospital operating room
Medical Devices·356 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Spine Pack, Kit number AMS3753 and AMS3783(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·86 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Foot Pack, Kit number AMS3637 convenience custom kits used for general surgery in hospital operating room
Medical Devices·85 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Minor Lap Pack, Kit number AMS2624 convenience custom kits used for general surgery in hospital operating room
Medical Devices·130 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Set Up Pack, Kit number PSS3574(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·16 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Major Kit, Kit number PHC1307(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·175 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Taymour GYN Pack, Kit number PSS2642 convenience custom kits used for general surgery in hospital operating room
Medical Devices·15 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Arthroscopy Pack, Kit numbers AMS2938, AMS3639, PSS1592(B, PSS1799, and PSS1845(A. convenience custom kits used for general surgery in h...
Medical Devices·5,723 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Laminectomy Pack, Kit number AMS2763, AMS2763(A, PSS1844, PSS1844(B convenience custom kits used for general surgery in hospital operati...
Medical Devices·838 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Laparotomy Kit, Kit number PSS1036(A and PSS1036(B convenience custom kits used for general surgery in hospital operating room
Medical Devices·230 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Transvaginal Pack, Kit number CMP1767 convenience custom kits used for general surgery in hospital operating room
Medical Devices·1,780 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Head and Neck Pack, kit numbers AMS1373(A, AMS1869, AMS2534, and AMS2534(A. convenience custom kits used for general surgery in hospital...
Medical Devices·2,004 affected·Apr 22, 2015
High RiskFDA
Ge Healthcare
CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner utilizing a new sol...
Medical Devices·4 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Student Pack-NS, Kit number PSS2788 convenience custom kits used for general surgery in hospital operating room
Medical Devices·5 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Abdominoplasty Tray, there are two Kit part numbers: PSS1782 and PSS1782(A. convenience custom kits used for general surgery in hospit...
Medical Devices·192 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Augmentation Mammoplasty Tray, Kit part number AMS2234. convenience custom kits used for general surgery in hospital operating room
Medical Devices·132 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Ortho Pack, Kit number PSS3466 and PSS3466(A convenience custom kits used for general surgery in hospital operating room
Medical Devices·92 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Mammoplasty Pack, Kit number AMS2535 convenience custom kits used for general surgery in hospital operating room
Medical Devices·140 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Major Breast Pack, Kit number AMS3409 convenience custom kits used for general surgery in hospital operating room
Medical Devices·20 affected·Apr 22, 2015
High RiskFDA
Windstone Medical Packaging, Inc.
Robotic Pack, Kit number AMS4389 convenience custom kits used for general surgery in hospital operating room
Medical Devices·33 affected·Apr 22, 2015