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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 Devices·98 affected·Nov 9, 2021
High RiskFDA
Boston Scientific Corporation
Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).
Medical Devices·7 affected·Nov 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 Devices·187 affected·Nov 8, 2021
High RiskFDA
Ge Healthcare, Llc
GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
Medical Devices·12,526 affected·Nov 4, 2021
High RiskFDA
Ge Healthcare, Llc
GE Vscan Extend, being sold as "Vscan Extend Dual USB"
Medical Devices·12,526 affected·Nov 4, 2021
High RiskFDA
Wright Medical Technology Inc
INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
Medical Devices·2 affected·Nov 4, 2021
High RiskFDA
Ge Healthcare, Llc
GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
Medical Devices·12,526 affected·Nov 4, 2021
High RiskFDA
Ge Healthcare, Llc
GE Vscan Extend, being sold as "Vscan Extend Sector USB"
Medical Devices·12,526 affected·Nov 4, 2021
High RiskFDA
Ge Healthcare, Llc
GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"
Medical Devices·12,526 affected·Nov 4, 2021
High RiskFDA
Ge Healthcare, Llc
GE Vscan Extend, being sold as "Vscan Extend Console"
Medical Devices·12,526 affected·Nov 4, 2021
High RiskFDA
Ge Healthcare, Llc
GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
Medical Devices·12,526 affected·Nov 4, 2021
High RiskFDA
Haag-streit Usa Inc
OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
Medical Devices·3 affected·Nov 3, 2021
High RiskFDA
Olympus Corporation Of The Americas
EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
Medical Devices·14,447 affected·Nov 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 Devices·137,200 affected·Nov 2, 2021
High RiskFDA
Human Care Usa, Inc.
Hanger-Bar 2P 45cm
Medical Devices·15 affected·Nov 1, 2021
High RiskFDA
Smith & Nephew, Inc.
smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
Medical Devices·38 affected·Nov 1, 2021
High RiskFDA
Randox Laboratories Ltd.
RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
Medical Devices·15 affected·Nov 1, 2021
High RiskFDA
Smith & Nephew, Inc.
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102
Medical Devices·35 affected·Nov 1, 2021
High RiskFDA
Smith & Nephew, Inc.
smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202
Medical Devices·41 affected·Nov 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 Devices·245 affected·Oct 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 Devices·620 affected·Oct 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 Devices·103 affected·Oct 28, 2021
High RiskFDA
Medline Industries Inc
EVLP Convenience Pack/Kit
Medical Devices·28 affected·Oct 27, 2021
High RiskFDA
Medline Industries Inc
Venous Access Pack-LF Convenience Kit
Medical Devices·15 affected·Oct 27, 2021
High RiskFDA
Medline Industries Inc
Major Vascular CDS Convenience Kit
Medical Devices·15 affected·Oct 27, 2021
High RiskFDA
Medline Industries Inc
Bedside PICC CDS Convenience Kit
Medical Devices·1 affected·Oct 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 Devices·9,900 affected·Oct 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 Devices·9 affected·Oct 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 Devices·87,972 affected·Oct 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 Devices·0 affected·Oct 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 Devices·711 affected·Oct 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 Devices·0 affected·Oct 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 Devices·0 affected·Oct 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 Devices·546 affected·Oct 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 Devices·0 affected·Oct 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 Devices·0 affected·Oct 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 Devices·0 affected·Oct 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 Devices·0 affected·Oct 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 Devices·11,607 affected·Oct 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 Devices·74 affected·Oct 19, 2021
High RiskFDA
Drg International, Inc.
Total Thyroxine (T4) ELISA; REF EIA-1781
Medical Devices·314 affected·Oct 18, 2021
High RiskFDA
Western/scott Fetzer Company
Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602
Medical Devices·40 affected·Oct 16, 2021
High RiskFDA
Western/scott Fetzer Company
Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603
Medical Devices·40 affected·Oct 16, 2021
High RiskFDA
Western/scott Fetzer Company
Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600
Medical Devices·4,974 affected·Oct 16, 2021
High RiskFDA
Howmedica Osteonics Corp.
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
Medical Devices·0 affected·Oct 15, 2021
High RiskFDA
Howmedica Osteonics Corp.
28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
Medical Devices·0 affected·Oct 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 Devices·2,254 affected·Oct 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 Devices·1,050 affected·Oct 14, 2021