Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Coopersurgical, Inc. D.b.a. Lone Star Medical Products
Blunt Hurd Cannula Blunt Tip 10 mm with 5 mm Reducer simplifies open laparoscopy.
Medical Devices·90 affected·Sep 13, 2013
High RiskFDA
Kerr/pentron, Dba Kerr Corporation And Pentron Clinical
NX3 Try-In Gel. The product is used as a tooth shade resin material.
Medical Devices·197 affected·Sep 13, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provid...
Medical Devices·1,131 affected·Sep 11, 2013
High RiskFDA
Spinefrontier, Inc.
PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
Medical Devices·13 affected·Sep 11, 2013
High RiskFDA
Aesculap, Inc.
Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to generate electr...
Medical Devices·85 affected·Sep 10, 2013
High RiskFDA
Hospira Inc.
Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Number 43056-01; 2) List Number 43023-01; 3) List Number 4...
Medical Devices·67,410,861 affected·Sep 10, 2013
High RiskFDA
Becton Dickinson & Co.
BBL (tm) MGIT (tm) Mycobacteria Growth Indicator Tube, part # 245122, packaged in 100 ct cartons and labeled in part Product Usage: ...
Medical Devices·187,000 affected·Sep 9, 2013
High RiskFDA
Hospira Inc.
*** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET, MICRODRIP,PP SOLUSET,FILTER, 3 CLAVE PORTS, OPTION-...
Medical Devices·3,920,932 affected·Sep 9, 2013
High RiskFDA
Beckman Coulter Inc.
ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analyt...
Medical Devices·4,584 affected·Sep 9, 2013
High RiskFDA
Hospira Inc.
*** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CL...
Medical Devices·3,920,932 affected·Sep 9, 2013
High RiskFDA
Hospira Inc.
*** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch...
Medical Devices·1 affected·Sep 9, 2013
High RiskFDA
Beckman Coulter Inc.
ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measure...
Medical Devices·4,584 affected·Sep 9, 2013
High RiskFDA
Winco Mfg., Llc
PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, OPTIONAL Heat or ...
Medical Devices·369 affected·Sep 6, 2013
High RiskFDA
Winco Mfg., Llc
XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Removable side panels, Built-in head-rest...
Medical Devices·369 affected·Sep 6, 2013
High RiskFDA
Winco Mfg., Llc
CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recessed hand-grips, Webbed suspension seat...
Medical Devices·369 affected·Sep 6, 2013
High RiskFDA
Biomerieux, Inc.
chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the detection of Salmonella in huma...
Medical Devices·90 affected·Sep 6, 2013
High RiskFDA
Baxter Healthcare Corp.
Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, n...
Medical Devices·3,200 affected·Sep 4, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
(Siemens Rad Fluoro Uro Systems) Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10 Image intensif...
Medical Devices·357 affected·Sep 3, 2013
High RiskFDA
Cincinnati Sub-zero Products Inc
Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 Mosteller Road, Cincinnati, OH 45241 Hyper-Hypothermia dev...
Medical Devices·115 affected·Sep 3, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. BrightView XCT is a gamma cam...
Medical Devices·371 affected·Sep 3, 2013
High RiskFDA
Physician Engineered Products, Inc.
Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60
Medical Devices·97 affected·Aug 31, 2013
High RiskFDA
Zimmer, Inc.
Natural-Knee¿ Flex Femoral Component. Provides increased flexion capability.
Medical Devices·33,987 affected·Aug 30, 2013
High RiskFDA
Zimmer, Inc.
CoCr Head (Not distributed in the United States) Used in total hip replacement.
Medical Devices·604,064 affected·Aug 30, 2013
High RiskFDA
Implantech Associates Inc
Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mand...
Medical Devices·8 affected·Aug 30, 2013
High RiskFDA
Zimmer, Inc.
NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States)
Medical Devices·3,475 affected·Aug 30, 2013
High RiskFDA
Zimmer, Inc.
Metasul¿ Head. Intended for use either with or without bone cement in total hip arthroplasty.
Medical Devices·194 affected·Aug 30, 2013
High RiskFDA
Zimmer, Inc.
Zimmer¿ Unicompartmental Knee Femoral Component. Indicated for patients with painful and/or disabling knee joint.
Medical Devices·32,537 affected·Aug 30, 2013
High RiskFDA
Carefusion 303, Inc.
SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
Medical Devices·15,860 affected·Aug 30, 2013
High RiskFDA
Zimmer, Inc.
Multipolar¿ Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip.
Medical Devices·72,806 affected·Aug 30, 2013
High RiskFDA
Zimmer, Inc.
NexGen¿ Femoral Component (CR-FLEX GSF POR FEM, C-L; CR-FLEX GSF POR FEM, C-R; CR-FLEX GSF POR FEM, C-L MINUS; CR-FLEX GSF POR FEM, C-R M...
Medical Devices·11,694 affected·Aug 30, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brillian...
Medical Devices·258 affected·Aug 30, 2013
High RiskFDA
Zimmer, Inc.
Gender Solutions" Patello-Femoral Component
Medical Devices·5,103 affected·Aug 30, 2013
High RiskFDA
Zimmer, Inc.
NexGen¿ Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R ; CR-FLEX GSF PCT SZ C-L MINUS; CR-FLEX GSF PCT SZ ...
Medical Devices·604,064 affected·Aug 30, 2013
High RiskFDA
Carestream Health Inc.
CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY ...
Medical Devices·364 affected·Aug 29, 2013
High RiskFDA
Carestream Health Inc.
DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14...
Medical Devices·190 affected·Aug 29, 2013
High RiskFDA
Integra Lifesciences Corp.
Composite Series Skull Clamp, one clamp per tote. The MAYFIELD¿ Skull Clamp (A3059) is a cranial stabilization device, designed to pr...
Medical Devices·37 affected·Aug 29, 2013
High RiskFDA
Fresenius Medical Care Holdings, Inc.
2008K@ Home Blood lines Combiset True Flow Series for Hemodialysis use Catalog Number: 03-2962-3. Intended for use as the extracorpor...
Medical Devices·8,528 affected·Aug 29, 2013
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Combiset Blood Line Hemodialysis use Catalog Number: 03-2622-3. Intended for use as the extracorporeal blood circuit during Hemodial...
Medical Devices·508,029 affected·Aug 29, 2013
High RiskFDA
Steris Corporation
Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The inte...
Medical Devices·266 affected·Aug 29, 2013
High RiskFDA
Zimmer, Inc.
Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates The compression tube/plates of this trauma system are used wit...
Medical Devices·2,632 affected·Aug 28, 2013
High RiskFDA
Globus Medical, Inc.
Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony voids or gaps th...
Medical Devices·193 affected·Aug 28, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with software versions VB10G. Product Usage: Image Intensified ...
Medical Devices·76 affected·Aug 28, 2013
High RiskFDA
Zimmer, Inc.
VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for tota...
Medical Devices·12,866 affected·Aug 28, 2013
High RiskFDA
Smith & Nephew Inc
GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, T...
Medical Devices·16 affected·Aug 27, 2013
High RiskFDA
Smith & Nephew Inc
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 381...
Medical Devices·46 affected·Aug 27, 2013
High RiskFDA
Smith & Nephew Inc
GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38...
Medical Devices·80 affected·Aug 27, 2013