Category

Medical Devices Recalls

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

15,654 recalls
CriticalFDA
Medex Cardio-pulmonary Inc., D.b.a. Smiths Medical Company
Medline Prefilled 550 ml Sterile¿¿ ¿
Medical Devices·54,924 affected·Sep 5, 2017
RecallFDA
Coopervision Inc.
Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses are indicated fo...
Medical Devices·120 affected·Sep 1, 2017
High RiskFDA
Aesculap Implant Systems Llc
The ELAN 4 Air System is intended for high speed cutting, sawing and drilling of bone in fields of Spine, ENT, Neuro, and Maxillofacial S...
Medical Devices·167 affected·Sep 1, 2017
High RiskFDA
Permobil, Ab
Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
Medical Devices·146 affected·Sep 1, 2017
High RiskFDA
Respire Medical
Respire Pink Series EF+ Oral Sleep Apnea Device.
Medical Devices·1 affected·Sep 1, 2017
High RiskFDA
Respire Medical
Respire Pink H/S Oral Sleep Apnea Device
Medical Devices·0 affected·Sep 1, 2017
High RiskFDA
Respire Medical
Respire Pink H/S Oral Sleep Apnea Device
Medical Devices·0 affected·Sep 1, 2017
High RiskFDA
Aaren Scientific Inc.
AERO IOL Injection System containing 10 Z28 Cartridges per box, Part #003500-0025-282, Sterile, Rx. The firm name on the label is Aaren...
Medical Devices·786 affected·Sep 1, 2017
High RiskFDA
Respire Medical
Respire Pink+ Hard/Soft Oral Sleep Apnea Device
Medical Devices·29 affected·Sep 1, 2017
High RiskFDA
Permobil, Ab
Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS ...
Medical Devices·5,539 affected·Sep 1, 2017
High RiskFDA
Depuy Mitek, Inc., A Johnson & Johnson Co.
1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Gravity Tube Set is intended to deliver irrigation fluid from irrigation conta...
Medical Devices·15,678 affected·Aug 31, 2017
High RiskFDA
Carl Zeiss Meditec Ag
Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABE...
Medical Devices·9 affected·Aug 30, 2017
High RiskFDA
Becton Dickinson & Company
BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematolo...
Medical Devices·8,494,000 affected·Aug 29, 2017
High RiskFDA
Zimmer Biomet, Inc.
AGC 2000 LP Patella, labeled as AGC Porous Patellar SM, Model Number 150802. Product Usage: For use in Total Knee Arthroplasty.
Medical Devices·28 affected·Aug 25, 2017
High RiskFDA
Firefly Medical, Inc.
IVEA Product Part Number 16100 Model 500A
Medical Devices·570 affected·Aug 24, 2017
High RiskFDA
Philips Electronics North America Corporation
IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient...
Medical Devices·7,071 affected·Aug 23, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza systems with SW VB20A, Model Number - 10863171, 10863172, 10863173 Product Usage: Syngo.plaza is a Picture Archiving and ...
Medical Devices·76 affected·Aug 23, 2017
High RiskFDA
The Binding Site Group, Ltd.
Human Alpha-1-Antitrypsin Kit for use on the SPAPlus analyser, Product #NK034.S. The firm name on the label is The Binding Site Group Lt...
Medical Devices·361 affected·Aug 23, 2017
High RiskFDA
Smiths Medical Asd Inc.
Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pembe...
Medical Devices·9,787 affected·Aug 22, 2017
High RiskFDA
Smiths Medical Asd Inc.
Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pem...
Medical Devices·9,787 affected·Aug 22, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Syngo.plaza Picture Archiving and Communication System (PACS) with software version VB20A; Model numbers: 10863171, 10863172, 10863173 ...
Medical Devices·47 affected·Aug 18, 2017
High RiskFDA
Olympus Corporation Of The Americas
A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge, one way" (Lots 146W to 172W) and A20977A "Bridge, two w...
Medical Devices·8,741 affected·Aug 18, 2017
High RiskFDA
Integra Lifesciences Corp.
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
Medical Devices·250 affected·Aug 18, 2017
High RiskFDA
Ethicon, Inc.
Coated VICRYL RAPIDETM (Polyglactin 910) Suture
Medical Devices·129,372 affected·Aug 17, 2017
High RiskFDA
Deerfield Imaging
IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw
Medical Devices·6 affected·Aug 14, 2017
High RiskFDA
Argo Medical Technologies Ltd
ReWalk Personal 6.0. Catalog number: 50-20-0004.
Medical Devices·127 affected·Aug 14, 2017
High RiskFDA
Medline Industries Inc
Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.
Medical Devices·1,428 affected·Aug 10, 2017
High RiskFDA
Synthes Usa
Norian Drillable Inject
Medical Devices·5 affected·Aug 10, 2017
High RiskFDA
Nucletron Bv
Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V. Oncentra is a radiation therapy planning ...
Medical Devices·89 affected·Aug 10, 2017
High RiskFDA
Carefusion 303, Inc.
Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Ass...
Medical Devices·31,622 affected·Aug 9, 2017
High RiskFDA
Lifecell Corporation, A Wholly Owned Subsidiary Of Allergan Plc
REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body ...
Medical Devices·25,798 affected·Aug 8, 2017
High RiskFDA
Alcon Research, Ltd.
Alcon Custom Pak
Medical Devices·33 affected·Aug 8, 2017
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, 125 DEG 11MM X 180MM
Medical Devices·638 affected·Aug 7, 2017
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 125 DEG 11MM X 360MM
Medical Devices·638 affected·Aug 7, 2017
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 440MM
Medical Devices·638 affected·Aug 7, 2017
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 125 DEG 11MM X 440MM
Medical Devices·638 affected·Aug 7, 2017
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 340MM
Medical Devices·638 affected·Aug 7, 2017
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 130 DEG 11MM X 400MM
Medical Devices·638 affected·Aug 7, 2017
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 320MM
Medical Devices·638 affected·Aug 7, 2017
High RiskFDA
Mako Surgical Corporation
Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist th...
Medical Devices·349 affected·Aug 7, 2017
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 130 DEG 9MM X 400MM
Medical Devices·638 affected·Aug 7, 2017
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 340MM
Medical Devices·638 affected·Aug 7, 2017
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 9MM X 320MM
Medical Devices·638 affected·Aug 7, 2017
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, 130 DEG 9MM X 180MM
Medical Devices·638 affected·Aug 7, 2017
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 125 DEG 9MM X 460MM
Medical Devices·638 affected·Aug 7, 2017
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 13MM X 440MM
Medical Devices·638 affected·Aug 7, 2017
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, RH 130 DEG 11MM X 360MM
Medical Devices·638 affected·Aug 7, 2017
High RiskFDA
Zimmer Biomet, Inc.
Affixus Hip Fracture Nail, LH 125 DEG 9MM X 380MM
Medical Devices·638 affected·Aug 7, 2017