Category

Medical Devices Recalls

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

15,654 recalls
High RiskFDA
Dixi Medical Usa
The DIXI Medical Microdeep Depth Electrode (Microdeep Depth Electrode or Electrode) is a smooth electrode that is 0.8 mm in diameter ...
Medical Devices·365 affected·Dec 9, 2021
High RiskFDA
Technomed Europe
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
Medical Devices·117,672 affected·Dec 8, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
Medical Devices·3 affected·Dec 7, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
Medical Devices·140 affected·Dec 7, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
Medical Devices·781 affected·Dec 7, 2021
High RiskFDA
Depuy Orthopaedics, Inc.
GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
Medical Devices·870 affected·Dec 7, 2021
High RiskFDA
Abbott Molecular, Inc.
Alinity m System, Part No. 08N53-002
Medical Devices·742 affected·Dec 6, 2021
High RiskFDA
Wright Medical Technology Inc
Stryker DARCO Screw, Locking, Ti6A14V, REF DC2825016, 2.7mm x 16mm.
Medical Devices·250 affected·Dec 3, 2021
High RiskFDA
Wright Medical Technology, Inc.
Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw, Model #41122718, 2.7mm x 18mm, a component of the CHARLOTTE Lisfranc Reconstructi...
Medical Devices·22 affected·Dec 3, 2021
High RiskFDA
Philips Medical Systems Nederland B.v.
Zenition 50, Model #718096
Medical Devices·16 affected·Dec 2, 2021
High RiskFDA
Livanova Usa, Inc.
Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) ...
Medical Devices·10 affected·Dec 2, 2021
High RiskFDA
Natus Neurology Dba Excel Tech., Ltd. (xltek)
IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks software
Medical Devices·221 affected·Dec 2, 2021
High RiskFDA
Philips Medical Systems Nederland B.v.
Veradius Unity, Model #718132
Medical Devices·12 affected·Dec 2, 2021
High RiskFDA
Maquet Cardiovascular, Llc
Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890
Medical Devices·2 affected·Dec 1, 2021
High RiskFDA
Activbody, Inc.
Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5 User Manual: ACTIV5 USER MANUAL Welcome to Activ5, the first isometrics...
Medical Devices·501 affected·Nov 30, 2021
High RiskFDA
Roi Cps Llc
Regard, T AND A - Rogers, sterilized convenience kits
Medical Devices·195 affected·Nov 30, 2021
High RiskFDA
Straumann Usa Llc
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
Medical Devices·1 affected·Nov 30, 2021
High RiskFDA
Philips North America Llc
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
Medical Devices·2,925,800 affected·Nov 29, 2021
High RiskFDA
Philips North America Llc
Heel Snuggler, Reference # 989805603411 99047
Medical Devices·2,509,100 affected·Nov 29, 2021
High RiskFDA
Ion Beam Applications S.a.
Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Medical Devices·5 affected·Nov 29, 2021
High RiskFDA
Philips North America Llc
Infant Heel Warmers w/strap, Reference # 989805603201 1223
Medical Devices·5,164,600 affected·Nov 29, 2021
High RiskFDA
Philips North America Llc
Cardinal Infant Heel Warmer, Reference # 989805617251 11470-010T
Medical Devices·4,920,600 affected·Nov 29, 2021
High RiskFDA
Philips North America Llc
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Medical Devices·141,744 affected·Nov 26, 2021
High RiskFDA
Nikkiso Ltd - Shizuoka Plant
DBB-06 Hemodialysis Delivery System
Medical Devices·781 affected·Nov 24, 2021
CriticalFDA
Philips North America Llc
Philips Allura Xper, UNIQ(Allura Xper system-China) Interventional Fluoroscopic X-ray System products with a Laird chiller WITHOUT an ex...
Medical Devices·63 affected·Nov 24, 2021
CriticalFDA
Philips North America Llc
Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a Laird chiller without an extended drip tray: Model Number: ...
Medical Devices·1 affected·Nov 24, 2021
High RiskFDA
Gentherm Medical, Llc
Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Medical Devices·484 affected·Nov 22, 2021
High RiskFDA
Qiagen Sciences Llc
QIAcube Connect MDx, Model No. 9003070
Medical Devices·93 affected·Nov 21, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Edge Plus-Computed tomography system Model 1026700
Medical Devices·80 affected·Nov 19, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition AS-Computed tomography system Model 8098027
Medical Devices·794 affected·Nov 19, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Definition Edge -Computed tomography system Model 10590000
Medical Devices·0 affected·Nov 19, 2021
High RiskFDA
Medtronic Sofamor Danek Usa Inc
Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery
Medical Devices·4 affected·Nov 19, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
SOMATOM Confidence -Computed tomography systems Model 10590100
Medical Devices·108 affected·Nov 19, 2021
High RiskFDA
Medshape, Inc.
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Medical Devices·26 affected·Nov 17, 2021
High RiskFDA
Stanley Security Solutions Inc
Senior Living Arial Emergency and Nurse Call Systems
Medical Devices·11 affected·Nov 17, 2021
High RiskFDA
Beaver Visitec International, Inc.
Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884
Medical Devices·680 affected·Nov 17, 2021
High RiskFDA
Beaver Visitec International, Inc.
Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery....
Medical Devices·1,170 affected·Nov 17, 2021
High RiskFDA
Beaver Visitec International, Inc.
Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK...
Medical Devices·920 affected·Nov 17, 2021
High RiskFDA
Beaver Visitec International, Inc.
Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK833/2
Medical Devices·120 affected·Nov 17, 2021
High RiskFDA
Abbott
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Medical Devices·10 affected·Nov 16, 2021
High RiskFDA
Ohio Medical Corporation
Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac ...
Medical Devices·649 affected·Nov 16, 2021
CriticalFDA
Datascope Corp.
Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75, 0998-UC-0800-75, 0998-00-0800-83, 0998-UC-0800-83, 0998-00-08...
Medical Devices·44 affected·Nov 15, 2021
High RiskFDA
Invacare Corporation
Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: IFX-20R, ...
Medical Devices·303 affected·Nov 12, 2021
High RiskFDA
Philips North America Llc
Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency ...
Medical Devices·10 affected·Nov 12, 2021
High RiskFDA
Covidien Llc
Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery cha...
Medical Devices·2 affected·Nov 12, 2021
CriticalFDA
Medtronic Navigation, Inc.
Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1. or SynergyCranial Software. Synergy Cranial, Model: 9733763...
Medical Devices·2,587 affected·Nov 11, 2021
RecallFDA
Tapemark Company
iontoPATCH On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System, Extra Strength, 8-HOUR Average Wear Time, 6/1-patch ...
Medical Devices·5,141 affected·Nov 10, 2021
High RiskFDA
Abbott
Amplatzer Steerable Delivery Sheath
Medical Devices·529 affected·Nov 9, 2021