Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Zimmer, Inc.
Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 53, 54, 55, 5...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
Magna-Fx Cannulated Screw Fixation System 7.0 mm. Item codes starting with 0011420, 11460 and 11461.
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
VERSA-FX KEYLESS 90D X 8 and X 11, VERSA-FX KEYLESS 95D X 8, X 11, and X 14, VERSA-FX KEYLESS 140D X 4 and X 5, VERSA-FX KEYLESS 135D X 4...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting with 0022520, 0022521, 002522, 0022523, 0022524...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
3.5 COMP PLT, 4 HOLE 3.5 COMP PLT, 5 HOLE 3.5 COMP PLT, 6 HOLE 3.5 COMP PLT, 8 HOLE 3.5 COMP PLT, 9 HOLE 3....
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIUS, PROXIMAL DORSAL ULNA PLT, and PROXIMAL MEDIAL TIBIAL 4.
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
ZIMTRON 6 DEG 22 HEADS
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
ASIA ONE-PIECE LAG SCREW
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
HERBERT BONE SCREW, 3.0MM and HERBERT CANNULATED BONE S
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0022543.
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
INTERLOCKING IM SCREW SML, MED and LRG; M/DN TIBIAL I/M NAIL 6 MM to 15 MM. Some items starting with codes 0022530, 0022531, 002532, 0...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
COMPRESSION SCREW (1/2, 1-1/2, 1-1/4, 1-3/4, 1. 2. 3/4 IN)
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
12/14 UNIPOLAR FEMORAL HE VERSYS CEM LD/FX SZ 11X12 VERSYS CEM LD/FX SZ 12X12 VERSYS CEM LD/FX SZ 14X13 VERSYS CEM LD/FX SZ 16X14 VE...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
TRILOGY ACET SHELL 36MM O TRILOGY ACET SHELL 38MM O TRILOGY ACET SHELL 40MM O TRILOGY ACET SHELL 42MM O TRILOGY ACET SHELL 44MM O TR...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB PL NEXGEN MICRO ALL-POLY PAT NEXGEN ALL-POLY PATELLA, NE...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
HGP II ACETABULAR CUP MOD
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
HGP II ACETABULAR CUP BON
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
6 DEGREE COCR FEM HEAD 36
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900.
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
VERSA-FX II KEYLESS TUBE, VERSA-FX II KEYLESS SHORT, VERSA-FX II SHORT TUBE PL, VERSA-FX II STD TUBE PLAT and VERSA-FX II SUPRACONDYLR ...
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System intended ...
Medical Devices·9 affected·Oct 11, 2013
High RiskFDA
Zimmer, Inc.
M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400
Medical Devices·7,044,680 affected·Oct 11, 2013
High RiskFDA
Cayenne Medical Inc.
Drill (Fluted-Hard Bone), for Quattro Link 2.9mm, labeled as: a. Quattro Spade Drill, for 2.9mm, Model Number CM-9300; b. Quattro...
Medical Devices·229 affected·Oct 10, 2013
High RiskFDA
Nanosphere, Inc.
The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of...
Medical Devices·220 affected·Oct 10, 2013
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products Mixing Cup Arrays utilized on VITROS 250 & 350 Chemistry Systems Product Usage: Mixing Cup Array is a dispo...
Medical Devices·6,380 affected·Oct 10, 2013
High RiskFDA
Stryker Howmedica Osteonics Corp.
VariAx Compression Plating System
Medical Devices·118 affected·Oct 10, 2013
High RiskFDA
Neurotherm, Inc.
Neurotherm NT2000iX RF Generator Model Number: RFG-NT -2000iX
Medical Devices·25 affected·Oct 9, 2013
High RiskFDA
Ge Healthcare, Llc
GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by compute...
Medical Devices·272 affected·Oct 9, 2013
High RiskFDA
Smith & Nephew Inc
GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
Medical Devices·4 affected·Oct 7, 2013
High RiskFDA
Lap Of America Laser Applications, Llc
CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient a...
Medical Devices·280 affected·Oct 7, 2013
High RiskFDA
Smith & Nephew Inc
GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic
Medical Devices·4 affected·Oct 7, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA) restricts the device to use b...
Medical Devices·67 affected·Oct 2, 2013
RecallFDA
Helix Medical Llc
Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
Medical Devices·47 affected·Oct 1, 2013
High RiskFDA
Toshiba American Medical Systems Inc
TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion ...
Medical Devices·338 affected·Oct 1, 2013
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.
Medical Devices·1,024 affected·Sep 30, 2013
High RiskFDA
Medtronic Neuromodulation
Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.
Medical Devices·64,163 affected·Sep 30, 2013
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.
Medical Devices·1,690 affected·Sep 30, 2013
High RiskFDA
Cordis Corporation
Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement...
Medical Devices·29,395 affected·Sep 27, 2013
High RiskFDA
Ethicon, Inc.
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft...
Medical Devices·37,164 affected·Sep 25, 2013
High RiskFDA
Baxter Healthcare Corp.
Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deerfield, IL 30015 USA The VIAL-MATE is recons...
Medical Devices·38,400 affected·Sep 25, 2013
High RiskFDA
Baxter Healthcare Corp.
SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 revision B) Product Usage: Intended to be ...
Medical Devices·346 affected·Sep 24, 2013
High RiskFDA
Ebi, Llc
Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal...
Medical Devices·2 affected·Sep 24, 2013
High RiskFDA
Volcano Corp
Volcano s5/s5x/CORE Mobile Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5 - 804200-002 and 804200-014; s...
Medical Devices·227 affected·Sep 23, 2013
High RiskFDA
Ivoclar Vivadent, Inc.
ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 dental adhesive for restorations
Medical Devices·63 affected·Sep 23, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Portex¿ Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesthesia family of products is comprised of sterile (unless othe...
Medical Devices·830 affected·Sep 23, 2013