Category

Medical Devices Recalls

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

15,654 recalls
CriticalFDA
Bard Peripheral Vascular, Inc
Halo One 5F Introducer Sheath 90 cm Product Code: HAL590 Product Usage: The Halo One Thin-Walled Guiding Sheath is designed to per...
Medical Devices·101 affected·Dec 2, 2016
CriticalFDA
Bard Peripheral Vascular, Inc
Halo One 5F Introducer Sheath 45 cm Product Code: HAL545 The Halo One Thin-Walled Guiding Sheath is designed to perform as both a guidi...
Medical Devices·101 affected·Dec 2, 2016
High RiskFDA
Polymer Technology Systems
A1CNow+ Systems (professional use product), Software Version Revision D, REF Numbers US: 3021, 3024; EU: 3037, 3038, 3057, 3058
Medical Devices·112,648 affected·Dec 2, 2016
High RiskFDA
Varian Medical Systems, Inc.
Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] ...
Medical Devices·42 affected·Dec 2, 2016
High RiskFDA
Perkinelmer Health Sciences, Inc.
Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Software Version 1.0 Specimen Gate Laboratory is intended for use ...
Medical Devices·21 affected·Dec 1, 2016
High RiskFDA
Pride Mobility Products Corp
TRU-Balance 3 Power Positioning Systems, TB3 Lift/Tilt/Recline (Gen 1). Mobility Medical Device
Medical Devices·12,343 affected·Dec 1, 2016
High RiskFDA
Atricure, Inc.
AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed p...
Medical Devices·464 affected·Nov 30, 2016
High RiskFDA
Boston Scientific Corporation
Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
Medical Devices·15 affected·Nov 30, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical 400 Series Express Drains as follows: 4000-100N Express single collection drain with in-line connector 4000-100P Expre...
Medical Devices·964,463 affected·Nov 29, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical Dual Chamber Ocean Drains as follows: 2020-000 Ocean dual chamber, in-line connectors and suction control stopcock (2 Pa...
Medical Devices·964,463 affected·Nov 29, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical Oasis Pediatric Drain as follows: 3612-100 Oasis Infant/Pediatric drain with in-line connector, ¿ in. tubing, Sims and P...
Medical Devices·964,463 affected·Nov 29, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical Oasis Single Drain as follows: 3600-100 Oasis single drain with in-line connector 3600-150 Oasis single drain with in-l...
Medical Devices·964,463 affected·Nov 29, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical Pediatric Chamber Ocean Drains as follows: 2012-320 Ocean Infant/Pediatric drain, with in-line connector and suction con...
Medical Devices·964,463 affected·Nov 29, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical Ocean Drains as follows: 2002-000 Ocean single drain, with in-line connectors and suction control stopcock 2002-040 Oc...
Medical Devices·964,463 affected·Nov 29, 2016
High RiskFDA
Atrium Medical Corporation
Atrium Medical Ocean Blood Recovery Drains as follows: 2050-000 Ocean Blood Recovery drain with in-line connector and suction control s...
Medical Devices·964,463 affected·Nov 29, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
XCELA PASV 5F DL 55CM MST-70 KIT PG, UPN H965457320, Catalog No. 45-732 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and B...
Medical Devices·4,591 affected·Nov 28, 2016
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
GoDirect Screw-Retaining Top Part Numbers: 4500-61
Medical Devices·14 affected·Nov 28, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
XCELA PASV 5F DL 55CM IR-145 KIT PG, UPN H965457330, Catalog No. 45-733 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and B...
Medical Devices·4,591 affected·Nov 28, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Bio-Stable 5F DL-55CM IR-145 Kit Valved with Nit GW, UPN H965458890, Catalog No. 45-889 The Xcela with PASV, BioFlo PICC with ENDEXO T...
Medical Devices·4,591 affected·Nov 28, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved PG, UPN H965458710, Catalog No. 45-871 The Xcela with PASV, BioFlo PICC with ENDEXO Techno...
Medical Devices·4,591 affected·Nov 28, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
XCELA PASV 5F DL 55CM IR-145 Nitinol Wire KIT PG, UPN H965251260, Catalog No. 25-126 The Xcela with PASV, BioFlo PICC with ENDEXO Tech...
Medical Devices·4,591 affected·Nov 28, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO...
Medical Devices·4,591 affected·Nov 28, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, UPN H965458180, Catalog No. 45-818 The Xcela with PASV, BioFlo PICC with ENDEXO Technolog...
Medical Devices·4,591 affected·Nov 28, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250, Catalog No. 25-125 ...
Medical Devices·4,591 affected·Nov 28, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer r...
Medical Devices·1 affected·Nov 25, 2016
High RiskFDA
Health Robotics S.r.l.
i.v. Station and i.v. Station ONCO Automated Drug Compounding System, Pharmacy Compounding System Device Listing Number E454448
Medical Devices·121 affected·Nov 23, 2016
High RiskFDA
Allen Medical Systems, Inc.
Arthex S3 Arm Sleeve Connector; Catalog Number AR-1650-02; manufactured and distributed between March and November 2016.
Medical Devices·420 affected·Nov 23, 2016
High RiskFDA
Medline Industries Inc
Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds
Medical Devices·117,059 affected·Nov 23, 2016
High RiskFDA
Amendia, Inc
K-Wire 1.4mm x 12in Non-Threaded, Part Number 9080-12U; K-Wire Threaded 1.4mm x 18, Part Number 9080-18T; K-Wire Non-Threaded 1.4mm x 18,...
Medical Devices·5,833 affected·Nov 22, 2016
High RiskFDA
Amendia, Inc
Black Widow 6.6mm x 20mm Screw, Part Number TBS020; Black Widow 6.6mm x 25mm Screw, Part Number TBS025; Black Widow 6.6mm x 30mm Screw, P...
Medical Devices·96 affected·Nov 22, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Perspective, Computed tomography x-ray system
Medical Devices·13 affected·Nov 22, 2016
High RiskFDA
Amendia, Inc
Zeus-P Lumbar Interbody Device
Medical Devices·25 affected·Nov 22, 2016
High RiskFDA
Amendia, Inc
Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed...
Medical Devices·1,078 affected·Nov 22, 2016
High RiskFDA
Amendia, Inc
Optimus Fixed Awl
Medical Devices·9 affected·Nov 22, 2016
High RiskFDA
Amendia, Inc
Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300...
Medical Devices·240 affected·Nov 22, 2016
High RiskFDA
Abbvie Inc.
AbbVie PEG Kit 20 FR
Medical Devices·541 affected·Nov 22, 2016
High RiskFDA
Amendia, Inc
Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skel...
Medical Devices·6 affected·Nov 22, 2016
High RiskFDA
Reckitt Benckiser Llc
Durex Pleasure Pack . 3 ultra fine lubricated latex condoms 12 ultra fine lubricated latex condoms 24 Ra fine lubricated latex condom...
Medical Devices·108,342 affected·Nov 22, 2016
High RiskFDA
Ge Healthcare, Llc
Prestige VH
Medical Devices·1,598 affected·Nov 21, 2016
High RiskFDA
Ge Healthcare, Llc
Precision 500D
Medical Devices·1,598 affected·Nov 21, 2016
High RiskFDA
Ino Therapeutics (dba Ikaria)
Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system. Model 10007. Delivers INOMAX (nitric oxide for inhalation). The INOma...
Medical Devices·45 affected·Nov 21, 2016
High RiskFDA
Ge Healthcare, Llc
ADVANTX LCA
Medical Devices·1,598 affected·Nov 21, 2016
High RiskFDA
Ge Healthcare, Llc
Prestige SI
Medical Devices·1,598 affected·Nov 21, 2016
High RiskFDA
Ge Healthcare, Llc
RFX
Medical Devices·1,598 affected·Nov 21, 2016
High RiskFDA
Ge Healthcare, Llc
ADVANTX LCV+
Medical Devices·1,598 affected·Nov 21, 2016
High RiskFDA
Cryolife, Inc.
CryoPatch SG Pulmonary Hemi-Artery Patch
Medical Devices·1 affected·Nov 21, 2016
High RiskFDA
Ge Healthcare, Llc
Prestilix
Medical Devices·1,598 affected·Nov 21, 2016
High RiskFDA
Ge Healthcare, Llc
Innova 2000
Medical Devices·1,598 affected·Nov 21, 2016