510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK 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

59,460 records, page 55 of 1190
FDA device recalls, page 55 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0936-2026Class II5008X CAREsystem +CLiC +CDX;Fresenius Medical Care Renal Therapies Group, LLCKDI
Z-1155-2026Class IIBrand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product...EDAN Diagnostics, Inc.MHX
Z-1154-2026Class IIBrand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A...EDAN Diagnostics, Inc.MHX
Z-1153-2026Class IIBrand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product...EDAN Diagnostics, Inc.DQA
Z-1152-2026Class IIBrand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product...EDAN Diagnostics, Inc.DQA
Z-1151-2026Class IIBrand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS...EDAN Diagnostics, Inc.HGM
Z-1150-2026Class IIBrand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number...EDAN Diagnostics, Inc.MHX
Z-1149-2026Class IIBrand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12...EDAN Diagnostics, Inc.MHX
Z-1148-2026Class IIBrand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product...EDAN Diagnostics, Inc.MHX
Z-1147-2026Class IIBrand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product...EDAN Diagnostics, Inc.MHX
Z-1146-2026Class IIBrand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6...EDAN Diagnostics, Inc.MHX
Z-1145-2026Class IIBrand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70...EDAN Diagnostics, Inc.MHX
Z-1144-2026Class IIBrand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As...EDAN Diagnostics, Inc.MWI
Z-1143-2026Class IIBrand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product...EDAN Diagnostics, Inc.DQA
Z-1142-2026Class IIBrand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product...EDAN Diagnostics, Inc.DQA
Z-0875-2026Class IISenographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and...GE HealthcareMUE
Z-0879-2026Class IIMAMMOMAT Fusion;Siemens Medical Solutions USA, Inc.MUE
Z-0878-2026Class IIMAMMOMAT Inspiration;Siemens Medical Solutions USA, Inc.MUE
Z-0877-2026Class IIMAMMOMAT Revelation;Siemens Medical Solutions USA, Inc.MUE
Z-1141-2026Class IIBrand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6...EDAN Diagnostics, Inc.HGM
Z-1140-2026Class IIBrand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product...EDAN Diagnostics, Inc.HGM
Z-0932-2026Class IIICardiosave RescueDatascope Corp.DSP
Z-0931-2026Class IIICardiosave HybridDatascope Corp.DSP
Z-0484-2026Class IIBD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;Becton Dickinson & CoLIB
Z-3164-2026Class IIBrand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR...Nuclein LLCNSU
Z-1382-2026Class IIOlympus Thunderbeat 5 mm, 10 cm, Inline GripOLYMPUS Corporation of the AmericasLFL
Z-1381-2026Class IIOlympus Thunderbeat, 5 mm, 20 cm, Inline GripOLYMPUS Corporation of the AmericasLFL
Z-1380-2026Class IIOlympus Thunderbeat, 5 mm, 35 cm, Inline GripOLYMPUS Corporation of the AmericasLFL
Z-1379-2026Class IIOlympus Thunderbeat, 5 mm, 45 cm Inline GripOLYMPUS Corporation of the AmericasLFL
Z-1378-2026Class IIOlympus Thunderbeat, 5mm, 35 cm, Pistol GripOLYMPUS Corporation of the AmericasLFL
Z-1377-2026Class IIOlympus Thunderbeat, 5 mm, 45 cm, Pistol GripOLYMPUS Corporation of the AmericasLFL
Z-1376-2026Class IIOlympus Thunderbeat 5 mm, 20 cm, Front-Actuated GripOLYMPUS Corporation of the AmericasLFL
Z-1375-2026Class IIOlympus Thunderbeat 5 mm, 35 cm, Front-Actuated GripOLYMPUS Corporation of the AmericasLFL
Z-1374-2026Class IIOlympus Thunderbeat, 5 mm, 45 cm Front-Actuated GripOLYMPUS Corporation of the AmericasLFL
Z-1373-2026Class IIOlympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type SOLYMPUS Corporation of the AmericasLFL
Z-1372-2026Class IIOlympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type SOLYMPUS Corporation of the AmericasLFL
Z-1371-2026Class IIOlympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type SOLYMPUS Corporation of the AmericasLFL
Z-0602-2026Class IIBioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)BioFire Diagnostics, LLCQOF
Z-0594-2026Class IICareLink Clinic, REF: MMT-7350Medtronic, Inc.PHV
Z-0500-2026Class IIIVerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The...Accriva Diagnostics, Inc.JOZ
Z-0539-2026Class IIMedtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03Medtronic Perfusion SystemsJBP
Z-0721-2026Class IIIsoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the...Datascope Corp.BSZ
Z-0720-2026Class IISevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the...Datascope Corp.BSZ
Z-0543-2026Class IIMONARCH Bronchoscope. Model Number: MBR-000211-BAuris Health, IncQNW
Z-0723-2026Class IIIntelePACS - InteleConnect / TechPortalIntelerad Medical Systems IncorporatedLLZ
Z-0426-2026Class IIMAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC...Mozarc Medical US LLCNIE
Z-0425-2026Class IIMAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC...Mozarc Medical US LLCNIE
Z-0424-2026Class IIMAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC...Mozarc Medical US LLCNIE
Z-0423-2026Class IIMAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC...Mozarc Medical US LLCNIE
Z-0422-2026Class IIMAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC...Mozarc Medical US LLCNIE