Category

Medical Devices Recalls

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

15,654 recalls
CriticalFDA
Philips Electronics North America Corporation
The following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura Xper Releases 3 to 8.1: Allura Xper F...
Medical Devices·6,992 affected·Mar 22, 2017
High RiskFDA
Zimmer Biomet, Inc.
Regenerex Patella RGX 3 PEG SER A PATELLA 28MM RGX 3 PEG SER A PATELLA 31MM RGX 3 PEG SER A PATELLA 34MM RGX 3 PEG SER A PATELLA 37MM...
Medical Devices·8,154 affected·Mar 22, 2017
CriticalFDA
Cook Medical Incorporated
Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of ...
Medical Devices·4,916 affected·Mar 22, 2017
High RiskFDA
Ion Beam Applications S.a.
Proteus 235, Proton Therapy System
Medical Devices·2 affected·Mar 21, 2017
High RiskFDA
Arrow International Inc
Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral a...
Medical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Roho Inc.
ROHO HIGH PROFILE Single Compartment Cushion with Sensor Ready Technology and ROHO MID PROFILE Single Compartment Cushion with Sensor Re...
Medical Devices·5,646 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Pressure injectable Jugular Axillo-Subclavian Central CThe CG+Arrow JACC powered by Arrow VPS Stylet permits venous access to the central...
Medical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Arrow PICC with Chlorag+ard Technology The ArrowEVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic T...
Medical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral...
Medical Devices·0 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral a...
Medical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology The ArrowEVOLUTIONTM Pressure injectable P1CC with chlorag+ard Anti...
Medical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
AGB+ Pressure Injectable Multi-Lumen CVC Kit intended to permit venous access to the central circulation by way of the femoral, jugular ...
Medical Devices·0 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Arrow Pressure Injectable PICC Kit The Arrow International Pressure Injectable PICC is intended for short-term or long-term peripheral a...
Medical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Arrow International Inc
Arrow PICC with Chlorag+ard Technology A PICC permits venous access to the central circulation through a peripheral vein
Medical Devices·43,394 affected·Mar 20, 2017
High RiskFDA
Smiths Medical Asd Inc.
CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
Medical Devices·38,415 affected·Mar 17, 2017
High RiskFDA
Eden Spine Europe Sa
GIZA Vertebral Body Replacement
Medical Devices·1,839 affected·Mar 17, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Cataract Pack, part numbers 008886-1, AMS2806, PSS3442, PSS3442(A, WAL1155, and WAL1155(A. Product packaged in a convenient manner for u...
Medical Devices·7,508 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Dicken Eye Pack, part number CPA-3202-2. Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·172 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
PRK Tray, part number DDS1044 Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·20 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Vitrectomy Kit, part number CMP1016(A. Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·440 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Ophthalmic Pack, Part number WAL1107(A and WAL1190 Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·169 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Vitrectomy Pack, part number AMS4952 Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·100 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Setup Pack, part number AMS3112(A Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·500 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Dr. Wischmeier Pack, part numbers: AMS3509 and AMS3509(A Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·1,170 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·260 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
ENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·16 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Cataract Kit - Dr. Slingsby, part number CMP1017(B. Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·990 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·4,065 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Eye Cataract Pack, part numbers AMS1359 and AMS1359-1 Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·1,520 affected·Mar 16, 2017
High RiskFDA
Windstone Medical Packaging, Inc.
Minor Operation Kit, part number AMS1530 Product packaged in a convenient manner for use in a general clinical procedure
Medical Devices·700 affected·Mar 16, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number: 72204039 The ACUFEX TRUNAV Retrograde Drill is intended for use in ...
Medical Devices·0 affected·Mar 15, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 72204043 The ACUFEX TRUNAV Retrograde Drill is intended for use in...
Medical Devices·0 affected·Mar 15, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM Product Number: 72204040 The ACUFEX TRUNAV Retrograde Drill is intended for use in cr...
Medical Devices·0 affected·Mar 15, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number: 72204048 The ACUFEX TRUNAV Retrograde Drill is intended for use in c...
Medical Devices·0 affected·Mar 15, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number: 72204050 The ACUFEX TRUNAV Retrograde Drill is intended for use in c...
Medical Devices·0 affected·Mar 15, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM Product Number: 72204041 The ACUFEX TRUNAV Retrograde Drill is intended for use in ...
Medical Devices·0 affected·Mar 15, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number: 72204042 The ACUFEX TRUNAV Retrograde Drill is intended for use in c...
Medical Devices·0 affected·Mar 15, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10MM Product Number: 72204046 The ACUFEX TRUNAV Retrograde Drill is intended for use in c...
Medical Devices·0 affected·Mar 15, 2017
High RiskFDA
Measurement Specialties Inc
Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as Esophageal/Rectal (Adult), Esophageal/Rectal (Pediatric), and S...
Medical Devices·6,076 affected·Mar 13, 2017
High RiskFDA
Instradent Usa, Inc.
NEODENT CM Intraoral Scanbody, Article Number: 108.139
Medical Devices·170 affected·Mar 13, 2017
High RiskFDA
Nihon Kohden America Inc
Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CN...
Medical Devices·654 affected·Mar 13, 2017
High RiskFDA
Beckman Coulter Inc.
Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
Medical Devices·889 affected·Mar 10, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraop...
Medical Devices·65 affected·Mar 10, 2017
High RiskFDA
Ge Healthcare, Llc
Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
Medical Devices·396 affected·Mar 10, 2017
High RiskFDA
Ge Healthcare, Llc
Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
Medical Devices·971 affected·Mar 10, 2017
High RiskFDA
Smith & Nephew, Inc.
D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410 (b) 2.4MM X 12MM, RES 74692...
Medical Devices·197 affected·Mar 9, 2017
High RiskFDA
Centurion Medical Products Corporation
CUSTOM CADAVER KIT The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed ...
Medical Devices·540 affected·Mar 9, 2017
High RiskFDA
Smith & Nephew, Inc.
Peri-Loc(R) VLP 3.5 MM X 6 MM SELF-TAPPING CORTEX SCREW, QTY: (1), STERILE R, REF 71801306 Orthopedic
Medical Devices·1 affected·Mar 9, 2017