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 353 of 1190
FDA device recalls, page 353 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1682-2020Class IIMcKesson Cardiology ECG Management, Change Healthcare Cardiology ECG ManagementChange Healthcare Canada CompanyDQK
Z-1447-2020Class IIKits containing Covidien Force TriVerse Electrosurgical Devices. Distributed in EMEA...Medtronic, Inc.GEI
Z-1501-2020Class IIYsio, model no. 10281013 Product Usage: The product is a stationary X-Ray system.Siemens Medical Solutions USA, Inc.KPR
Z-1502-2020Class IIAGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray...Agfa N.V.IZF
Z-1446-2020Class IICovidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI...Medtronic, Inc.GEI
Z-1475-2020Class IIGetinge 88-Series-washer disinfectors intended for cleaning, disinfection and...Maquet Cardiovascular Us Sales, LLCMEC
Z-1470-2020Class IIINeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage...Integra LifeSciences CorporationJXI
Z-1444-2020Class IIElecsys CA 19-9, Cat. No. 07027028190 - Product Usage: the product is an immunoassay for...Roche Diagnostics GmbHNIG
Z-1833-2020Class IIPrismaflex System, Prismaflex Control UnitBaxter Healthcare CorporationKDI
Z-1832-2020Class IIPrismaflex System, Prismaflex Control UnitBaxter Healthcare CorporationKDI
Z-1831-2020Class IIPrismaflex System, Prismaflex Control UnitBaxter Healthcare CorporationKDI
Z-1830-2020Class IIPrismaflex System, Prismaflex Control UnitBaxter Healthcare CorporationKDI
Z-1829-2020Class IIPrismaflex System, Prismaflex Control UnitBaxter Healthcare CorporationKDI
Z-1828-2020Class IIPrismaflex System, Prismaflex Control UnitBaxter Healthcare CorporationKDI
Z-1440-2020Class IIMonitor for the Functional Imaging System for Magnetic Resonance Imaging SystemInvivo CorporationLNH
Z-1483-2020Class IITeleflex Pilling Aortic Punch, 4.0mm. Sterile, Rx Only, disposable. Included as part of...Deroyal Industries, Inc. LafolletteDWS
Z-1534-2020Class IIVITEK 2 card AST-N371 - Product Usage: The VITEK 2 is an automated system consisting of...bioMerieux, Inc.N/A
Z-1514-2020Class IIIMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D)...Siemens Healthcare Diagnostics Inc.CHP
Z-1513-2020Class IIIMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product...Siemens Healthcare Diagnostics Inc.CHP
Z-1419-2020Class IIDeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the...Deroyal Industries, Inc. LafolletteLRO
Z-1418-2020Class IIDeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the following...Deroyal Industries, Inc. LafolletteLRO
Z-1417-2020Class IIDeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the...Deroyal Industries, Inc. LafolletteLRO
Z-1416-2020Class IIDeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the...Deroyal Industries, Inc. LafolletteLRO
Z-1415-2020Class IIDeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the...Deroyal Industries, Inc. LafolletteLRO
Z-1414-2020Class IIDeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the...Deroyal Industries, Inc. LafolletteLRO
Z-1413-2020Class IIDeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the...Deroyal Industries, Inc. LafolletteLRO
Z-1412-2020Class IIDeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the...Deroyal Industries, Inc. LafolletteLRO
Z-1411-2020Class IIDeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the...Deroyal Industries, Inc. LafolletteLRO
Z-1362-2020Class ICareFusion Alaris PCA Module, Model 8120CareFusion 303, IncFRN
Z-1361-2020Class ICareFusion Alaris Syringe Module, Model 8110CareFusion 303, IncFRN
Z-1360-2020Class ICareFusion Alaris Pump Module, Model 8100CareFusion 303, IncFRN
Z-1410-2020Class IIDeRoyal Sterile Custom Kits containing Cardinal Health Gowns. Sold as the...Deroyal Industries, Inc. LafolletteLRO
Z-1746-2020Class IIHEMO-10 Hemospray Endoscopic HemostatWilson-Cook Medical Inc.QAU
Z-1745-2020Class IIHEMO-7 Hemospray Endoscopic HemostatWilson-Cook Medical Inc.QAU
Z-1563-2020Class IIVNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS...LivaNova USA, Inc.LYJ
Z-1359-2020Class ICareFusion Alaris System, Alaris PC unit models 8000 and 8015 (UDI: 10885403801518)CareFusion 303, IncFRN
Z-1761-2020Class IIABL90 FLEX PLUS Analyzer, Model Number 393-092 - Product Usage: It is intended for use in...Radiometer Medical ApSCHL
Z-1760-2020Class IIABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product...Radiometer Medical ApSCEM
Z-1628-2020Class IIiTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY...ConforMIS, Inc.JWH
Z-1627-2020Class IIiTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE...ConforMIS, Inc.JWH
Z-1485-2020Class IITRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013Materialise N.V.JEY
Z-1484-2020Class IITRUMATCH Orthognathic - Full Bimaxillary Surgical Kit, Catalog Number SD980.001Materialise N.V.JEY
Z-1562-2020Class IIDexcom G6 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose...Dexcom, Inc.QBJ
Z-1561-2020Class IIDexcom G5 Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose...Dexcom, Inc.PQF
Z-1560-2020Class IIDexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM...Dexcom, Inc.MDS
Z-2820-2020Class IILDI Laser firmware lower than V02.13.00 for LDI models: LDl-7, LDI-WF, LDI-NIR...89 NorthREK
Z-2037-2020Class IISTEALTH SPRING CLIP 6mm latis (1/4 Force). Non-Sterile, REF/UDI::A1702/(01)10607915110649...Applied Medical Resources CorpDSS
Z-2036-2020Class IISTEALTH SPRING CLIP 6mm latis (3/4 Force). REF/UDI::A1603/(01)00607915110581 - Product...Applied Medical Resources CorpDSS
Z-2035-2020Class IISTEALTH SPRING CLIP 6mm latis (1/4 Force). REF/UDI::A1602/(01)00607915110574 - Product...Applied Medical Resources CorpDSS
Z-2034-2020Class IISTEALTH SPRING CLIP 6mm latis (1/2 Force). REF/UDI::A1601/(01)00607915110567 - Product...Applied Medical Resources CorpDSS