Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
IUD Insertion Kit
Medical Devices·14,959 affected·Sep 10, 2021
High RiskFDA
Kinsman Enterprises Inc
Easi-Care Gait Belt Metal Buckle (54", 60", and 72" lengths)
Medical Devices·13,123 affected·Sep 10, 2021
High RiskFDA
Inpeco S.a.
FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
Medical Devices·262 affected·Sep 10, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
Medical Devices·10 affected·Sep 9, 2021
High RiskFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-0...
Medical Devices·3,969 affected·Sep 8, 2021
High RiskFDA
Fujifilm Irvine Scientific, Inc.
Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (...
Medical Devices·3,981 affected·Sep 8, 2021
High RiskFDA
K2m, Inc
Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
Medical Devices·23 affected·Sep 8, 2021
High RiskFDA
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-0...
Medical Devices·5,054 affected·Sep 8, 2021
High RiskFDA
Medical Action Industries, Inc. 306
Kit: Central Line Dres Change 20/Cs
Medical Devices·42 affected·Sep 8, 2021
High RiskFDA
Nox Medical
Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Medical Devices·128 affected·Sep 7, 2021
CriticalFDA
Djo, Llc
Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, located in the following DJO, LLC / DJO FR...
Medical Devices·8,702 affected·Sep 7, 2021
High RiskFDA
Roche Molecular Systems, Inc.
cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
Medical Devices·507 affected·Sep 3, 2021
High RiskFDA
Flower Orthopedics Corporation
Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Medical Devices·77 affected·Sep 3, 2021
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Medical Devices·9 affected·Sep 2, 2021
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
Medical Devices·10 affected·Sep 2, 2021
High RiskFDA
Elekta, Inc.
MOSAIQ Oncology Information System
Medical Devices·31 affected·Sep 2, 2021
High RiskFDA
Biomerieux Sa
MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Medical Devices·542 affected·Sep 2, 2021
High RiskFDA
Centese Inc.
Thoraguard Chest Tube Kit, 20 Fr
Medical Devices·310 affected·Aug 31, 2021
High RiskFDA
Exactech, Inc.
OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XX...
Medical Devices·109,787 affected·Aug 30, 2021
High RiskFDA
Exactech, Inc.
OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion...
Medical Devices·33,103 affected·Aug 30, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
Medical Devices·298 affected·Aug 30, 2021
High RiskFDA
Exactech, Inc.
ARTHROFOCUS Polyethylene Tibial Inserts (Product Line: 256-12-XX, 256-13-XX). NOTE: Information reflects Exactech recall expansion i...
Medical Devices·12 affected·Aug 30, 2021
High RiskFDA
Exactech, Inc.
Vantage Total Ankle System including a. Vantage Fixed-Bearing Polyethylene Liner Component (Product Line: 350-21-XX, 350-22-XX); ...
Medical Devices·2,217 affected·Aug 30, 2021
High RiskFDA
Exactech, Inc.
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIA...
Medical Devices·31,201 affected·Aug 30, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS with software syngo.CT VB20 Model #8098027
Medical Devices·665 affected·Aug 30, 2021
High RiskFDA
Exactech, Inc.
OPTETRAK Comprehensive Knee System custom devices labeled as the following: a. CUSTOM OPTETRAK ANGLED PS INSERT (Product Line: 900-06...
Medical Devices·41 affected·Aug 30, 2021
High RiskFDA
Exactech, Inc.
OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with Product Line Nu...
Medical Devices·242,397 affected·Aug 30, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Force with software syngo.CT VB20 Model #10742326
Medical Devices·232 affected·Aug 30, 2021
CriticalFDA
North Coast Medical Inc
EcoLotion Transmission Lotion, used in ultrasound procedures. Item/Description: NC70481/Eco Lotion 5 liters, NC70482/Eco Lotion with Alo...
Medical Devices·53 affected·Aug 27, 2021
High RiskFDA
Xstrahl Limited
Treatment applicator for Gulmay Medical 150 or Xstrahl 150 superficial X-ray therapy system
Medical Devices·120 affected·Aug 27, 2021
High RiskFDA
North American Rescue Llc.
10 ga ARS Decompression Needle, Part Number ZZ-0298
Medical Devices·51,424 affected·Aug 27, 2021
CriticalFDA
North Coast Medical Inc
Norco Ultrasound Gel, Item/Description: NC70479/Norco Ultrasound Gel, 250 mL; NC70479/North Coast Ultrasound Gel, 250 mL; NC70479-5/Norco...
Medical Devices·576 affected·Aug 27, 2021
High RiskFDA
Ptw North America Corporation
Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
Medical Devices·1 affected·Aug 27, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA Pioneer nuclear magnetic resonance imaging system
Medical Devices·5 affected·Aug 26, 2021
High RiskFDA
Ge Healthcare, Llc
Optima MR450w 1.5T nuclear magnetic resonance imaging system
Medical Devices·13 affected·Aug 26, 2021
High RiskFDA
Ge Healthcare, Llc
1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
Medical Devices·3 affected·Aug 26, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA Architect nuclear magnetic resonance imaging system
Medical Devices·2 affected·Aug 26, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA Creator, SIGNA Explorer nuclear magnetic resonance imaging system
Medical Devices·6 affected·Aug 26, 2021
CriticalFDA
Atrium Medical Corporation
Atrium Pneumostat Chest Drain Valve, Part Number 16100
Medical Devices·92,430 affected·Aug 26, 2021
High RiskFDA
Ge Healthcare, Llc
Discovery MR750w 3.0T nuclear magnetic resonance imaging system
Medical Devices·13 affected·Aug 26, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA Voyager nuclear magnetic resonance imaging system
Medical Devices·15 affected·Aug 26, 2021
High RiskFDA
Ge Healthcare, Llc
SIGNA Artist nuclear magnetic resonance imaging system
Medical Devices·18 affected·Aug 26, 2021
High RiskFDA
Ge Healthcare, Llc
Discovery MR750 3.0T nuclear magnetic resonance imaging system
Medical Devices·5 affected·Aug 26, 2021
High RiskFDA
Atrium Medical Corporation
Atrium ADVANTA VXT Vascular Graft, Part No. 22059, UDI 00650862220599 - Product Usage: intended for use in arterial vascular reconstructi...
Medical Devices·28 affected·Aug 25, 2021
CriticalFDA
National Distribution & Contracting Inc
ECO 50TS Gel Tens Ultrasound 1in X 5L cube 1 Dispenser Btl
Medical Devices·3 affected·Aug 24, 2021
High RiskFDA
Zhejiang Kindly Medical Devices Co., Ltd.
HENRY SCHEIN Safety Blood Collection Needle 21Gx 1 1/4 Inch, REF 570-2067, 100pcs/box 1000pcs/ctn 350*210*350mm
Medical Devices·0 affected·Aug 24, 2021
High RiskFDA
Bard Peripheral Vascular Inc
Catalog # BEK4511, Qty: 10, Ecomomy Jamshidi Bone Marrow Biopsy and Aspiration Tray, 11 G X 4"Biopsy/Aspiration needle, 15 G Aspiration N...
Medical Devices·360 affected·Aug 24, 2021
High RiskFDA
Zhejiang Kindly Medical Devices Co., Ltd.
McKesson PREVENT HT Safety Winged Blood Collection Needle with Tube Holder, MFR # 16-NBCH21GS
Medical Devices·0 affected·Aug 24, 2021