Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Menarini Silicon Biosystems
CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿ CIRCULATING Tumor Cell Kit is intended for the enumer...
Medical Devices·0 affected·Apr 4, 2018
High RiskFDA
Handpiece Headquarters
Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not pro...
Medical Devices·252 affected·Apr 4, 2018
High RiskFDA
Baxter Healthcare Corporation
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product Usage: The Baxter Sigma Spectrum Infusion ...
Medical Devices·444 affected·Apr 3, 2018
High RiskFDA
Baxter Healthcare Corporation
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Product Usage: The Baxter Sigma Spectrum Infusion...
Medical Devices·444 affected·Apr 3, 2018
High RiskFDA
Baxter Healthcare Corporation
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion P...
Medical Devices·444 affected·Apr 3, 2018
High RiskFDA
Baxter Healthcare Corporation
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product Usage: The Baxter Sigma Spectrum Infusion ...
Medical Devices·444 affected·Apr 3, 2018
High RiskFDA
Synthes (usa) Products Llc
Retractor f/Sciatic Nerve; Part number: 03.100.013; UDI: 10886982070623
Medical Devices·235 affected·Apr 2, 2018
High RiskFDA
Smiths Medical Asd Inc.
Bivona¿ Tracheostomy Tube Tracheostomy Tubes
Medical Devices·16 affected·Apr 2, 2018
High RiskFDA
Synthes (usa) Products Llc
Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630
Medical Devices·196 affected·Apr 2, 2018
High RiskFDA
Aesdex
AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 The Cardica C-Port Flex-A PLUS Distal An...
Medical Devices·400 affected·Apr 2, 2018
High RiskFDA
Smith & Nephew, Inc.
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and rev...
Medical Devices·0 affected·Mar 30, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728240. Computed Tomography X-ray system
Medical Devices·2 affected·Mar 30, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 728246. Computed Tomography X-ray system
Medical Devices·20 affected·Mar 30, 2018
High RiskFDA
Smith & Nephew, Inc.
smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and re...
Medical Devices·16 affected·Mar 30, 2018
High RiskFDA
Ge Medical Systems, Scs
Innova IGS 630/520/530/540 Interventional Fluoroscopic X-ray Systems
Medical Devices·102 affected·Mar 29, 2018
High RiskFDA
Ge Medical Systems, Scs
Discovery IGS 730 Interventional Fluoroscopic X-ray Systems
Medical Devices·102 affected·Mar 29, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving c...
Medical Devices·1,145 affected·Mar 29, 2018
High RiskFDA
Ge Medical Systems, Scs
Discovery IGS 740 Interventional Fluoroscopic X-ray Systems
Medical Devices·102 affected·Mar 29, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance Big Bore Radiology 728244
Medical Devices·28 affected·Mar 28, 2018
High RiskFDA
Draegar Medical Systems, Inc.
Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS20401, MS20724, MS22956, MS25510, MS25520, MS25643, MS26196, MS2...
Medical Devices·25 affected·Mar 28, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Philips Ingenuity Core 728321
Medical Devices·28 affected·Mar 28, 2018
High RiskFDA
Zimmer Biomet, Inc.
Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.
Medical Devices·108 affected·Mar 28, 2018
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity Core128 728323
Medical Devices·28 affected·Mar 28, 2018
High RiskFDA
Ace Surgical Supply Co., Inc.
Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
Medical Devices·6 affected·Mar 28, 2018
High RiskFDA
Trilliant Surgical Ltd.
Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile
Medical Devices·90 affected·Mar 27, 2018
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.Via VB20A model 1049610
Medical Devices·0 affected·Mar 27, 2018
High RiskFDA
Zimmer Biomet, Inc.
M/DN Intramedullary Fixation Humeral Guide Wire Bullet Tip 2.4 mm Diameter, 70 cm Length; Item Number: 00-2255-026-00
Medical Devices·19,483 affected·Mar 26, 2018
High RiskFDA
Ethicon Endo-surgery Inc
5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2CB5ST
Medical Devices·11,074 affected·Mar 26, 2018
High RiskFDA
Ethicon Endo-surgery Inc
5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 75mm shaft length, 2B5ST
Medical Devices·14,873 affected·Mar 26, 2018
High RiskFDA
Zimmer Biomet, Inc.
Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length; Item Number: 47-2255-008-00
Medical Devices·19,483 affected·Mar 26, 2018
High RiskFDA
Ethicon Endo-surgery Inc
5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability Sleeve, 5mm, 150mm shaft length, 2B5XT
Medical Devices·1,500 affected·Mar 26, 2018
High RiskFDA
Tornier, Inc
AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabil...
Medical Devices·3,327 affected·Mar 26, 2018
High RiskFDA
Zimmer Biomet, Inc.
ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-038-00
Medical Devices·19,483 affected·Mar 26, 2018
High RiskFDA
Zimmer Biomet, Inc.
Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00
Medical Devices·19,483 affected·Mar 26, 2018
High RiskFDA
Zimmer Biomet, Inc.
Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 100 cm Length; Diameter; Item Number: 47-2490-097-01
Medical Devices·19,483 affected·Mar 26, 2018
High RiskFDA
Ethicon Endo-surgery Inc
5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability Sleeve, 5mm, 100mm shaft length, 2CB5LT
Medical Devices·95,233 affected·Mar 26, 2018
High RiskFDA
Zimmer Biomet, Inc.
ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00
Medical Devices·19,483 affected·Mar 26, 2018
High RiskFDA
Zimmer Biomet, Inc.
Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2255-008-01
Medical Devices·19,483 affected·Mar 26, 2018
High RiskFDA
Straumann Manufacturing, Inc.
Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099
Medical Devices·3,046 affected·Mar 23, 2018
High RiskFDA
Biomerieux Sa
The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test ...
Medical Devices·5 affected·Mar 23, 2018
High RiskFDA
Straumann Manufacturing, Inc.
Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Number 075.116W
Medical Devices·1,084 affected·Mar 23, 2018
High RiskFDA
Straumann Manufacturing, Inc.
Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113
Medical Devices·2,816 affected·Mar 23, 2018
High RiskFDA
Straumann Manufacturing, Inc.
Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Number 075.114W
Medical Devices·2,915 affected·Mar 23, 2018
CriticalFDA
Cook Inc.
Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and cells, in particula...
Medical Devices·2,267 affected·Mar 22, 2018
CriticalFDA
Becton Dickinson & Company
BD Vacutainer¿ Lithium Heparin Green Top Tube; Catalog Numbers: 1. 366664 (UDI: 50382903666640); 2. 367884 (UDI: 50382903678841); 3. 3678...
Medical Devices·117,816,603 affected·Mar 22, 2018
CriticalFDA
Becton Dickinson & Company
BD Vacutainer¿ EDTA Pink Top Tube; Catalog Numbers: 1. 367842 (UDI: 50382903678421); 2. 367899 (UDI: 50382903678995); 3. 368049 (UDI: 503...
Medical Devices·64,784,900 affected·Mar 22, 2018
CriticalFDA
Becton Dickinson & Company
BD Vacutainer¿ EDTA Tan Top Tube; Catalog Number: 367855 (UDI: 50382903678551)
Medical Devices·3,956,900 affected·Mar 22, 2018
High RiskFDA
Volcano Corporation
Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualitative and quantitative evaluation of vascular...
Medical Devices·8 affected·Mar 22, 2018