Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Zimmer, Inc.
ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
Medical Devices·8 affected·Jun 17, 2015
High RiskFDA
Agilent Technologies, Inc.
Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numbers: 5022-8226 - Auto DBS Card (LCMS Extraction Sys) 50 pk; A40015...
Medical Devices·364 affected·Jun 17, 2015
RecallFDA
Acon Laboratories, Inc.
Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol Detector is for ...
Medical Devices·1,283 affected·Jun 17, 2015
High RiskFDA
Sorin Group Usa, Inc.
Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Medical Devices·1,755 affected·Jun 15, 2015
High RiskFDA
Sorin Group Usa, Inc.
Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours.
Medical Devices·2,837 affected·Jun 15, 2015
High RiskFDA
Pega Medical Inc.
Slipped Capital Femoral Epiphysis (SCFE) Drivers of the Free-Gliding SCFE Screw System with catalogue number SCF-MLD265 and SCF-MLD273.
Medical Devices·4 affected·Jun 15, 2015
High RiskFDA
Sorin Group Usa, Inc.
Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Medical Devices·283 affected·Jun 15, 2015
High RiskFDA
Sorin Group Usa, Inc.
Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
Medical Devices·28 affected·Jun 15, 2015
High RiskFDA
Ge Healthcare
GE Healthcare Precision 500D Classical R & F system.
Medical Devices·788 affected·Jun 12, 2015
High RiskFDA
Microaire Surgical Instruments, Llc
ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use.
Medical Devices·168 affected·Jun 12, 2015
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim componen...
Medical Devices·11,360 affected·Jun 12, 2015
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component...
Medical Devices·42,645 affected·Jun 12, 2015
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim componen...
Medical Devices·34,676 affected·Jun 12, 2015
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim compone...
Medical Devices·36,607 affected·Jun 12, 2015
High RiskFDA
Medtronic Perfusion Systems
Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. ...
Medical Devices·1,304 affected·Jun 12, 2015
High RiskFDA
Justright Surgical, Llc
JustRight 5mm Reload, JR-REL25-2.0 Reload is packaged in cases of 12., placed in a tray and sealed with a Tyvek lid. Product Usage: ...
Medical Devices·1,452 affected·Jun 11, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SYNGO IMAGING (VERSION V30 and V31); Syngo Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, r...
Medical Devices·5 affected·Jun 11, 2015
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co.
Medical Devices·12 affected·Jun 10, 2015
High RiskFDA
Alliance Partners Llc
Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended f...
Medical Devices·21 affected·Jun 9, 2015
High RiskFDA
Olympus Scientific Solutions Americas
Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta Element, Delta Plus, DPO-4000-XX-U-EN-EN-PM-SP12, DPO-6000-...
Medical Devices·1,047 affected·Jun 9, 2015
High RiskFDA
Panoramic Rental Corp.
Panoramic X-ray Model PC-1000 The PC-1000 will enable the user to take panoramic x-ray images. The PC-1000/Laser 1000 will enable the ...
Medical Devices·7,885 affected·Jun 4, 2015
High RiskFDA
Biomet, Inc.
A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in th...
Medical Devices·75 affected·Jun 4, 2015
High RiskFDA
Gardner Denver Thomas Inc
THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage: medical aspirator
Medical Devices·508 affected·Jun 4, 2015
High RiskFDA
Biomet, Inc.
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
Medical Devices·50 affected·Jun 4, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same...
Medical Devices·40 affected·Jun 4, 2015
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Emotion 6; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same ...
Medical Devices·40 affected·Jun 4, 2015
High RiskFDA
Biomet, Inc.
Gentle Threads Interference Screw 9x35mm Full Thread. An interference fixation screw for use in soft tissue reattachment procedures
Medical Devices·41 affected·Jun 3, 2015
High RiskFDA
Perkinelmer
Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 The Wizard¿" gamma counter is intended to detect and...
Medical Devices·54 affected·Jun 3, 2015
High RiskFDA
Biomet, Inc.
Gentle Threads Interference Screw 10x25mm Round Head. An interference fixation screw for use in soft tissue reattachment procedures.
Medical Devices·53 affected·Jun 3, 2015
High RiskFDA
Omnilife Science Inc.
Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral component of a pr...
Medical Devices·146 affected·Jun 3, 2015
High RiskFDA
Perkinelmer
Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 The Wizard¿" gamma counter is intended to detect and count g...
Medical Devices·179 affected·Jun 3, 2015
High RiskFDA
Perkinelmer
Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 The Wizard¿" gamma counter is intended to detect an...
Medical Devices·2 affected·Jun 3, 2015
High RiskFDA
Stryker Endoscopy
SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Probes are indicated for arthroscopic procedures of the knee, sh...
Medical Devices·22,063 affected·Jun 3, 2015
CriticalFDA
Elite Biomedical Solutions Llc
Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and help protect the bezel assembly's internal components from ...
Medical Devices·609 affected·Jun 3, 2015
CriticalFDA
Elite Biomedical Solutions Llc
Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel assembly's internal components from ...
Medical Devices·346 affected·Jun 3, 2015
High RiskFDA
Perkinelmer
Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard¿" gamma counter is intended to detect and count gamma...
Medical Devices·63 affected·Jun 3, 2015
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used...
Medical Devices·55 affected·Jun 2, 2015
High RiskFDA
Arthrocare Corporation
EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indicated for abl...
Medical Devices·733 affected·Jun 2, 2015
High RiskFDA
Boston Scientific Corporation
CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the ampl...
Medical Devices·43 affected·Jun 2, 2015
CriticalFDA
Teleflex Medical
HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Right sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile....
Medical Devices·188,195 affected·Jun 1, 2015
High RiskFDA
Sechrist Industries Inc
Sechrist Low Profile Wheeled Stretcher, Model No. 21762-110-33H, 21762-110-36H, 21762-110-41H, 21762-135-33HJ, 21762-010-36H, 21762-010-4...
Medical Devices·81 affected·Jun 1, 2015
High RiskFDA
Merge Healthcare, Inc.
The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.
Medical Devices·341 affected·May 31, 2015
High RiskFDA
Stryker Howmedica Osteonics Corp.
Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly 19 mm Product Usage: The Triathlon PS X3 (posterior stab...
Medical Devices·26 affected·May 29, 2015
High RiskFDA
Mortara Instrument, Inc
ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting elec...
Medical Devices·176 affected·May 29, 2015
High RiskFDA
American Medical Systems Innovation Center - Silicon Valley
Tool, Stripper W/BLD, 18S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of a...
Medical Devices·16,710 affected·May 28, 2015
High RiskFDA
American Medical Systems Innovation Center - Silicon Valley
Fiber Cleaver; Fiber Cleaver is also used to score the outer jacket on EndoStat Fibers (Aura XP) The Fiber Cleaver is a reusable and...
Medical Devices·16,710 affected·May 28, 2015
High RiskFDA
Synthes, Inc.
Pull Reduction Device For 4.3mm Percutaneous Drill Guide; The pull reduction device with quick coupling is placed through the guide sleev...
Medical Devices·3,747 affected·May 28, 2015
High RiskFDA
American Medical Systems Innovation Center - Silicon Valley
Tool, Stripper W/BLD, 44S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an E...
Medical Devices·16,710 affected·May 28, 2015