510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,486 records, page 342 of 1190
FDA device recalls, page 342 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2390-2020Class IIMedtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and...Medtronic Sofamor Danek USA IncHRX
Z-2389-2020Class IIExtremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and...Medtronic Sofamor Danek USA IncHRX
Z-1963-2020Class IIDeRoyal Sterile Custom Kits packaged as a Piggy Back with the BD PosiFlush SF Saline...DeRoyal Industries, Inc.KDD
Z-2117-2020Class IIARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in...Abbott MedicalLCD
Z-2359-2020Class IIInfant/Child Reduced Energy Defibrillation Electrodes, Part Number: 3202380-006, for use...Physio Control, Inc.MKJ
Z-2257-2020Class IIARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP...Siemens Medical Solutions USA, Inc.OWB
Z-1983-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit...Access Scientific, Inc.FMF
Z-1982-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 10cm Quick Kit...Access Scientific, Inc.FMF
Z-1981-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Pediatric Kit...Access Scientific, Inc.FMF
Z-1980-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick Kit...Access Scientific, Inc.FMF
Z-1979-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell...Access Scientific, Inc.FMF
Z-1978-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Quick Kit...Access Scientific, Inc.FMF
Z-1977-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max Barrier Kit...Access Scientific, Inc.FMF
Z-1976-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Max Barrier Kit...Access Scientific, Inc.FMF
Z-1975-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick Kit...Access Scientific, Inc.FMF
Z-1974-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 8cm Quick Kit...Access Scientific, Inc.FMF
Z-1973-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site Kit, 4Fr...Access Scientific, Inc.FMF
Z-2256-2020Class IIProxiDiagnost N90, UDI 706100Philips North America LLCJAA
Z-1972-2020Class IIBD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm...Access Scientific, Inc.FMF
Z-2197-2020Class IIOLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T TransducerOLYMPUS Corporation of the AmericasFEO
Z-2535-2020Class IIPump Tube Set for MMS Libra and Solar Systems - Product Usage: Intended for use during...Laborie Medical Technologies, Canada ULCFEZ
Z-2336-2020Class IIsmith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in...Smith & Nephew, Inc.MBL
Z-2335-2020Class IIsmith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the...Smith & Nephew, Inc.MBL
Z-2334-2020Class IIsmith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in...Smith & Nephew, Inc.MBL
Z-2333-2020Class IIsmith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the...Smith & Nephew, Inc.MBL
Z-2332-2020Class IIsmith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in...Smith & Nephew, Inc.MBL
Z-2331-2020Class IIsmith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the...Smith & Nephew, Inc.MBL
Z-2108-2020Class IIARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage...Siemens Medical Solutions USA, Inc.OWB
Z-2372-2020Class IIPENTARAY NAV eco HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO...Biosense Webster IncMDT
Z-2371-2020Class IIPENTARAY NAV HIGH-DENSITY MAPPING CATHETER ELECTRODE EA 22 Rx only STERILE EO...Biosense Webster IncMTD
Z-2773-2020Class IIProteus 235 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and...Ion Beam Applications S.A.LHN
Z-2982-2020Class IIBioPlex 2200 Syphilis Total & RPR Linked Immunoabsorption Assay, Treponema...Bio-Rad Laboratories Inc.LIP
Z-2137-2020Class IIPhilips HeartStart XL Monitor/Defibrillators Model number: M4735A - Product Usage: is for...Philips North America LLCMKJ
Z-2061-2020Class IIRenuvion/ J-Plasma Precise Handpiece. Catalog numbers BVX-150B, BVX-270B, BVX-330B...Apyx Medical CorporationGEI
Z-2060-2020Class IIRenuvion/ J-Plasma Precise Open Handpiece. Catalog numbers BVX-044-BPS, BVX-044-BPP...Apyx Medical CorporationGEI
Z-2265-2020Class IIRegard. Item number: 830034. GS0348D- CVC Triple Lumen 20CM non Sulfa-Mercy.ROi CPS LLCFTN
Z-2134-2020Class IIPhilips Sterilizable Defibrillator Internal Paddles - Internal paddles are an accessory...Philips North America LLCMKJ
Z-1959-2020Class IISiemens Cios Spin VA30-mobile X-Ray system, Material # 10308194 - Product Usage: The...Siemens Medical Solutions USA, Inc.OWB
Z-1958-2020Class IISiemens Cios Alpha VA30-mobile X-Ray system, Material # 11105200 The Cios Alpha and Cios...Siemens Medical Solutions USA, Inc.OWB
Z-1957-2020Class IISiemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios...Siemens Medical Solutions USA, Inc.OWB
Z-2201-2020Class IITRUE METRIX SELF MONITORING BLOOD GLUCOSE SYSTEM - Product Usage: is intended for the...Trividia Health, Inc.NBW
Z-2429-2020Class IIOscar 2, Model 250 SystemSuntech Medical, Inc.DXN
Z-2051-2020Class IIStrep B Carrot Broth One-Step, 16x100mm Tube, 6ml, Item code Z46BX - Product Usage...Medtronic, Inc.PQZ
Z-2050-2020Class IIProfessional Urine Drug Control, Item code 88010 - Product Usage: The Alere Professional...Medtronic, Inc.JJW
Z-2049-2020Class IIB-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for...Medtronic, Inc.JIN
Z-2128-2020Class IICios Spin Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA30-10308194Siemens Medical Solutions USA, Inc.OWB
Z-2127-2020Class IICios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and...Siemens Medical Solutions USA, Inc.OWB
Z-2287-2020Class IIAcrysof, IQ IOL w/UltraSert System, AcrySof IQ ASPHERIC IOL, 20.5 D, SP ACRYLIC FOLDABLE...Alcon LaboratoriesHQL
Z-2196-2020Class IIGambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set...Baxter Healthcare CorporationFJK
Z-2195-2020Class IIGambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set - Product...Baxter Healthcare CorporationFJK