Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Volcano Corp
Volcano s5i/s5ix/s5iz/CORE Intravascular Ultrasound Imaging and Pressure System; Product/Part numbers: s5i -806300-020 ; s5ix/s5iz - ...
Medical Devices·227 affected·Sep 23, 2013
RecallFDA
Alere San Diego, Inc.
Alere Triage¿ TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory...
Medical Devices·38 affected·Sep 23, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Portex¿ Saddleblock Tray with Drugs  25g Quincke; 4795-20 The Regional Anesthesia family of products is comprised of sterile (unless ...
Medical Devices·222 affected·Sep 23, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597-20 The Regional Anesthesia family of products is comprised of sterile (unless other...
Medical Devices·3,980 affected·Sep 23, 2013
High RiskFDA
Smiths Medical Asd, Inc.
Portex¿ Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-20 The Regional Anesthesia family of products is comprised...
Medical Devices·200 affected·Sep 23, 2013
High RiskFDA
Aesculap, Inc.
Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
Medical Devices·30 affected·Sep 20, 2013
High RiskFDA
Aesculap, Inc.
Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, sizes F5-F7
Medical Devices·24 affected·Sep 19, 2013
CriticalFDA
Atossa Genetics, Inc.
Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT ...
Medical Devices·577 affected·Sep 19, 2013
High RiskFDA
Agfa Corp.
IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Picture Archiving and Communication System (PACS).
Medical Devices·4 affected·Sep 19, 2013
High RiskFDA
Richard Wolf Medical Instruments Corp.
Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: on...
Medical Devices·78 affected·Sep 18, 2013
High RiskFDA
Advanced Sterilization Products
STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and mo...
Medical Devices·2,995 affected·Sep 18, 2013
High RiskFDA
Deroyal Industries Inc
Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made ...
Medical Devices·738 affected·Sep 17, 2013
High RiskFDA
Deroyal Industries Inc
DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. ...
Medical Devices·409 affected·Sep 17, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UNLIMITED READING LIC ADD 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; Virtual Enterprise SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to provi...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; Virtual PWR Reading Basic SW 8 Pack The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UNLIMITED READING LIC ADD 10K EX/YR The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; Unlimited Reading LIC<15K EX/YR 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; MX WEB SVR W/3 MX-RAD LIC<50K EX/YR The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX RAD SW ADV CR/DR LAYOUT & VIEW The CARESTREAM PACS is an image management system whose intended use is to provid...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 15K EXAMS The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
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; MX WEB SW/ 1 MX-O CONCUR ACCESS LIC The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
CriticalFDA
Pentax Medical Company
PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an a...
Medical Devices·76 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX CLINIC SOFTWARE DICOM VIEWING 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; UNLIMITED READING LIC < 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provid...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; Virtual Access Pluse SW, StandAlone The CARESTREAM PACS is an image management system whose intended use is to pr...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-O SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provid...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Abbott Medical Optics, Inc.
STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed...
Medical Devices·834 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-RAD SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provi...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX WEB SW/25 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX WEB SW/1 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provi...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; Unlimited Reading LIC<7.5K EX/YR 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; Virtual PWR Reading Basic SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to ...
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
Carestream Health Inc.
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K EXAMS The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX WEB SW/10 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX PRINT SW AUTO LAYOUT PAGE & PRINT The CARESTREAM PACS is an image management system whose intended use is to pro...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 50K EXAMS The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX-O SA WORKSTATION SW LICENSE The CARESTREAM PACS is an image management system whose intended use is to provide c...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX WEB SW/5 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provi...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Abbott Medical Optics, Inc.
STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufactu...
Medical Devices·834 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP The CARESTREAM PACS is an image management system whose intended use is to pro...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-RAD SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provi...
Medical Devices·0 affected·Sep 16, 2013
CriticalFDA
Edwards Lifesciences, Llc
Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGF...
Medical Devices·12,034 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