Category
Medical Devices Recalls
15,654 medical devices recalls on record from CPSC, FDA, and USDA.
15,654 recalls
High RiskFDA
Medtronic Navigation, Inc.
Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bun...
Medical Devices98 affectedNov 9, 2021
High RiskFDA
Boston Scientific Corporation
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Medical Devices7 affectedNov 8, 2021
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72
Medical Devices187 affectedNov 8, 2021
High RiskFDA
Ge Healthcare, Llc
GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
Medical Devices12,526 affectedNov 4, 2021
High RiskFDA
Ge Healthcare, Llc
GE Vscan Extend, being sold as "Vscan Extend Dual USB"
Medical Devices12,526 affectedNov 4, 2021
High RiskFDA
Wright Medical Technology Inc
INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
Medical Devices2 affectedNov 4, 2021
High RiskFDA
Ge Healthcare, Llc
GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
Medical Devices12,526 affectedNov 4, 2021
High RiskFDA
Ge Healthcare, Llc
GE Vscan Extend, being sold as "Vscan Extend Sector USB"
Medical Devices12,526 affectedNov 4, 2021
High RiskFDA
Ge Healthcare, Llc
GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"
Medical Devices12,526 affectedNov 4, 2021
High RiskFDA
Ge Healthcare, Llc
GE Vscan Extend, being sold as "Vscan Extend Console"
Medical Devices12,526 affectedNov 4, 2021
High RiskFDA
Ge Healthcare, Llc
GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
Medical Devices12,526 affectedNov 4, 2021
High RiskFDA
Haag-streit Usa Inc
OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
Medical Devices3 affectedNov 3, 2021
High RiskFDA
Olympus Corporation Of The Americas
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
Medical Devices14,447 affectedNov 2, 2021
High RiskFDA
Magnolia Medical Technologies, Inc.
The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide N...
Medical Devices137,200 affectedNov 2, 2021
High RiskFDA
Human Care Usa, Inc.
Hanger-Bar 2P 45cm
Medical Devices15 affectedNov 1, 2021
High RiskFDA
Smith & Nephew, Inc.
smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
Medical Devices38 affectedNov 1, 2021
High RiskFDA
Randox Laboratories Ltd.
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Medical Devices15 affectedNov 1, 2021
High RiskFDA
Smith & Nephew, Inc.
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
Medical Devices35 affectedNov 1, 2021
High RiskFDA
Smith & Nephew, Inc.
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
Medical Devices41 affectedNov 1, 2021
High RiskFDA
Diversatek Healthcare
Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps, ti...
Medical Devices245 affectedOct 29, 2021
High RiskFDA
Stradis Medical, Llc Dba Stradis Healthcare
Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
Medical Devices620 affectedOct 28, 2021
High RiskFDA
Palodex Group Oy
Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray proj...
Medical Devices103 affectedOct 28, 2021
High RiskFDA
Medline Industries Inc
EVLP Convenience Pack/Kit
Medical Devices28 affectedOct 27, 2021
High RiskFDA
Medline Industries Inc
Venous Access Pack-LF Convenience Kit
Medical Devices15 affectedOct 27, 2021
High RiskFDA
Medline Industries Inc
Major Vascular CDS Convenience Kit
Medical Devices15 affectedOct 27, 2021
High RiskFDA
Medline Industries Inc
Bedside PICC CDS Convenience Kit
Medical Devices1 affectedOct 27, 2021
High RiskFDA
Max Lux Corp
The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength ...
Medical Devices9,900 affectedOct 26, 2021
High RiskFDA
Aesculap Implant Systems Llc
MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Medical Devices9 affectedOct 25, 2021
High RiskFDA
Atrium Medical Corporation
The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed...
Medical Devices87,972 affectedOct 22, 2021
High RiskFDA
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M0...
Medical Devices0 affectedOct 21, 2021
High RiskFDA
Amo Manufacturing Usa, Llc
iDesign, Model - G300: System AWS (International), System AWS (China), Advanced WaveScan Studio (United States); iDesign Refractive Studi...
Medical Devices711 affectedOct 21, 2021
High RiskFDA
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00...
Medical Devices0 affectedOct 21, 2021
High RiskFDA
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00...
Medical Devices0 affectedOct 21, 2021
High RiskFDA
Amo Manufacturing Usa, Llc
Catalys Precision Laser System, Models: Catalys-U (United States), Catalys-I (International), Catalys-C (China); and Catalys Precision La...
Medical Devices546 affectedOct 21, 2021
High RiskFDA
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900
Medical Devices0 affectedOct 21, 2021
High RiskFDA
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
Medical Devices0 affectedOct 21, 2021
High RiskFDA
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M0054...
Medical Devices0 affectedOct 21, 2021
High RiskFDA
Boston Scientific Corporation
HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M005...
Medical Devices0 affectedOct 21, 2021
High RiskFDA
Biomeme, Inc.
Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; S...
Medical Devices11,607 affectedOct 20, 2021
High RiskFDA
Infutronix Llc
Nimbus PainPro Ambulatory Infusion Pumps with software version v4, Model Number IT1072, sold as kit IT1075-DUKE-HSP, IT1076-DUKE-HSP and ...
Medical Devices74 affectedOct 19, 2021
High RiskFDA
Drg International, Inc.
Total Thyroxine (T4) ELISA; REF EIA-1781
Medical Devices314 affectedOct 18, 2021
High RiskFDA
Western/scott Fetzer Company
Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602
Medical Devices40 affectedOct 16, 2021
High RiskFDA
Western/scott Fetzer Company
Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603
Medical Devices40 affectedOct 16, 2021
High RiskFDA
Western/scott Fetzer Company
Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600
Medical Devices4,974 affectedOct 16, 2021
High RiskFDA
Howmedica Osteonics Corp.
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
Medical Devices0 affectedOct 15, 2021
High RiskFDA
Howmedica Osteonics Corp.
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
Medical Devices0 affectedOct 15, 2021
High RiskFDA
The Binding Site Group, Ltd.
Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK...
Medical Devices2,254 affectedOct 15, 2021
High RiskFDA
Hill-rom Inc.
These are communication systems, labeled as: a. NaviCare Nurse Call, Part Numbers: 3.6, 3.7, 3.9 b. Voalte Nurse Call, Part Number 4.0...
Medical Devices1,050 affectedOct 14, 2021