Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Maquet Datascope Corp - Cardiac Assist Division
CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PL...
Medical Devices·838 affected·Dec 16, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurations: The CentraLink system software ...
Medical Devices·7 affected·Dec 16, 2014
High RiskFDA
Synthes, Inc.
Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation. Used i...
Medical Devices·1,762 affected·Dec 15, 2014
High RiskFDA
Teleflex, Inc.
R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube is designated for oral or nasal intubation and are indicate...
Medical Devices·2,292,361 affected·Dec 12, 2014
High RiskFDA
Med Tec Inc
Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only,...
Medical Devices·11 affected·Dec 11, 2014
High RiskFDA
Med Tec Inc
Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (nylon and sherpa), Non-sterile re-usable ...
Medical Devices·2 affected·Dec 11, 2014
CriticalFDA
Covidien
Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, CVT812015, and CVT812025. The following models are not offe...
Medical Devices·1,032 affected·Dec 10, 2014
High RiskFDA
The Anspach Effort, Inc.
16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and cranium. Model MI...
Medical Devices·8 affected·Dec 10, 2014
High RiskFDA
Ge Healthcare
GE Healthcare, Proteus XR/a with wall stand model number 600-0301.
Medical Devices·3,096 affected·Dec 8, 2014
High RiskFDA
Baxter Healthcare Corp.
Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device is indicated for...
Medical Devices·8,640 affected·Dec 8, 2014
High RiskFDA
Mobius Imaging, Llc
Airo Mobile Intraoperative CT I Airo; Model #: MobiCT-32. Computed Tomography x-ray system.
Medical Devices·21 affected·Dec 8, 2014
High RiskFDA
Philips Medical Systems (cleveland) Inc
Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package Product Usage: Intended to produce cross-sec...
Medical Devices·500 affected·Dec 8, 2014
High RiskFDA
Invacare Corporation
G- Series Beds; G29 full length bed rails assembly
Medical Devices·2,499 affected·Dec 5, 2014
High RiskFDA
Orthovita, Inc., Dba Stryker Orthobiologics.
Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch 2110-0524 Be...
Medical Devices·2,155 affected·Dec 4, 2014
High RiskFDA
Baxter Corporation Englewood
Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. E...
Medical Devices·54,000 affected·Dec 4, 2014
High RiskFDA
Zimmer Manufacturing B.v.
Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either cemented or uncemented use i...
Medical Devices·68 affected·Dec 4, 2014
High RiskFDA
Trumpf Medical Systems, Inc.
IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) 102306940. Patient positioning during surgery, ranging from...
Medical Devices·3,303 affected·Dec 3, 2014
High RiskFDA
Trumpf Medical Systems, Inc.
(R)Cable remote control JUPITER, Material no.1219655, Serial number: to (incl.) 101998119. Patient positioning during surgery, ranging f...
Medical Devices·3,303 affected·Dec 3, 2014
High RiskFDA
Trumpf Medical Systems, Inc.
Cable remote control JUPITER / TS7500, Material no.1601926, Serial number: to (incl.) 101465919. Patient positioning during surgery, ran...
Medical Devices·3,303 affected·Dec 3, 2014
High RiskFDA
Arjo Hospital Equipment Ab
TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of ...
Medical Devices·567 affected·Dec 3, 2014
High RiskFDA
Trumpf Medical Systems, Inc.
Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 101287649. Patient positioning during surgery, ranging from ane...
Medical Devices·3,303 affected·Dec 3, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Force; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-r...
Medical Devices·7 affected·Dec 3, 2014
High RiskFDA
Trumpf Medical Systems, Inc.
IR remote control JUX, Material no.1307314, Serial number: to (incl.) 102338310 Patient positioning during surgery, ranging from anesthe...
Medical Devices·3,303 affected·Dec 3, 2014
High RiskFDA
Trumpf Medical Systems, Inc.
Cable remote control JUC, BUTTON, Material no.1239823, Serial number: to (incl.) 100143048. Patient positioning during surgery, ranging ...
Medical Devices·3,303 affected·Dec 3, 2014
High RiskFDA
Teleflex Medical
WECK Hemoclip¿ Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended for use in procedures involving vessels or...
Medical Devices·3,180 affected·Dec 3, 2014
High RiskFDA
Trumpf Medical Systems, Inc.
IR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.) 100139854. Patient positioning during surgery, ranging fro...
Medical Devices·3,303 affected·Dec 3, 2014
High RiskFDA
Trumpf Medical Systems, Inc.
Cable remote control JUPITER U, Material no.4500119, Serial number: to (incl.) 102306915. Patient positioning during surgery, ranging fr...
Medical Devices·137 affected·Dec 3, 2014
High RiskFDA
Trumpf Medical Systems, Inc.
IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 102006720. Patient positioning during surgery, ranging from a...
Medical Devices·3,303 affected·Dec 3, 2014
High RiskFDA
Innokas Medical Oy
VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique only); Innokas Medical CARESCAPE VC150 Rx Only Innokas Medic...
Medical Devices·20 affected·Dec 3, 2014
High RiskFDA
Ferno-washington Inc
Ferno Model 35X PROFlexx Stretchers, one unit per package
Medical Devices·46 affected·Dec 3, 2014
High RiskFDA
Trumpf Medical Systems, Inc.
IR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (incl.) 102222333. Patient positioning during surgery, rangin...
Medical Devices·3,303 affected·Dec 3, 2014
High RiskFDA
Zimmer Trabecular Metal Technology, Inc.
NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP...
Medical Devices·8 affected·Dec 2, 2014
High RiskFDA
Biomet, Inc.
Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920 The Biomet's Sirius Femoral Hip ...
Medical Devices·8 affected·Dec 2, 2014
High RiskFDA
Getinge Disinfection Ab
GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with dryer --- Class II, exempt from...
Medical Devices·551 affected·Nov 26, 2014
High RiskFDA
Scc Soft Computer
SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0
Medical Devices·108 affected·Nov 26, 2014
RecallFDA
Lacrimedics Inc
VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815, 1903, 1904, an...
Medical Devices·781 affected·Nov 26, 2014
High RiskFDA
Nonin Medical, Inc
SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 40 kg., Model 8003CA (REF 9824-001, 3-Wavelength), 8004CA (R...
Medical Devices·5,892 affected·Nov 25, 2014
High RiskFDA
Teleflex, Inc.
Carlens Bronchial Double Lumen Tube Set (Left) Sterile
Medical Devices·0 affected·Nov 21, 2014
High RiskFDA
Teleflex, Inc.
Bronchial Double Lumen Tube Set (Right), Sterile
Medical Devices·0 affected·Nov 21, 2014
High RiskFDA
Tomotherapy Incorporated
TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)
Medical Devices·210 affected·Nov 21, 2014
High RiskFDA
Becton Dickinson & Co.
BBL Port A Cul tubes with Swabs Sterile Pack, catalog number 221607. For patient sample collection.
Medical Devices·92,710 affected·Nov 21, 2014
High RiskFDA
Teleflex, Inc.
Bronchial One Lumen Tube - Left
Medical Devices·0 affected·Nov 21, 2014
High RiskFDA
Smiths Medical Asd, Inc.
Hypodermic Needle Pro¿ Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Nee...
Medical Devices·47,200 affected·Nov 21, 2014
High RiskFDA
Teleflex, Inc.
Bronchial Double Lumen Tube Set (Left), Sterile
Medical Devices·6,991 affected·Nov 21, 2014
High RiskFDA
Smiths Medical Asd, Inc.
Hypodermic Needle Pro¿ Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro¿ Edge Safety Hypodermic Need...
Medical Devices·334,000 affected·Nov 21, 2014
High RiskFDA
Teleflex, Inc.
Bronchial One Lumen Tube - Right
Medical Devices·0 affected·Nov 21, 2014
High RiskFDA
Zimmer Manufacturing B.v.
Bone Screw, self-tapping The Trilogy shells are available in three configurations; uni, multi, and cluster-holed. The multi and cluster-...
Medical Devices·6,377 affected·Nov 21, 2014
High RiskFDA
Teleflex, Inc.
Tracheopart Set (Right), Sterile
Medical Devices·0 affected·Nov 21, 2014