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

59,336 records, page 33 of 1187
FDA device recalls, page 33 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1758-2026Class IIBurlington Medical, BAT (Breast, Axilla and Thyroid) Coverage.Burlington Medical LLCIWO
Z-1757-2026Class IIBurlington Medical, Wrap Aprons.Burlington Medical LLCIWO
Z-1756-2026Class IIBurlington Medical, Frontal ApronsBurlington Medical LLCIWO
Z-1755-2026Class IIBurlington Medical, KiltBurlington Medical LLCIWO
Z-1754-2026Class IIBurlington Medical, VestBurlington Medical LLCIWO
Z-1652-2026Class IIEmbrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;Waldemar Link GmbH & Co. KGHTW
Z-1651-2026Class IIEmbrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;Waldemar Link GmbH & Co. KGHTW
Z-1753-2026Class IIBurlington Medical, Thyroid Shield.Burlington Medical LLCIWO
Z-1645-2026Class IIBD Alaris" System with Guardrails" Suite MX with Point of Care UnitCareFusion 303, IncFRN
Z-1630-2026Class IIDrill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee...OrthAlign, Inc.OLO
Z-1629-2026Class IIDrill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee...OrthAlign, Inc.OLO
Z-1650-2026Class IIPuracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL...MEDLINE INDUSTRIES, LP - NorthfieldKGN
Z-1551-2026Class IIEndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material...Boston Scientific CorporationPIF
Z-1574-2026Class IIArtegraft Vascular Graft; REF#: AG740;LeMaitre Vascular Inc.LXA
Z-1656-2026Class IIRefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00Reflexion Medical, Inc.QVA
Z-1565-2026Class IIProduct Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version...Abbott Diagnostics Scarborough, Inc.OZE
Z-1658-2026Class IIBD Kiestra" ReadA; Catalog No.: 446948.BD Kiestra B.V.JTQ
Z-1587-2026Class IIIBattery Charging Station; Model: 0998-00-0802;Datascope Corp.DSP
Z-1548-2026Class IOwner's Booklets and Instructions for Use that are used with the following blood glucose...Trividia Health, Inc.NBW
Z-1547-2026Class IOwner's Booklets and Instructions for Use that are used with the following blood glucose...Trividia Health, Inc.NBW
Z-1546-2026Class IOwner's Booklets and Instructions for Use that are used with the following blood glucose...Trividia Health, Inc.NBW
Z-1556-2026Class IIArtelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX...International Life SciencesOWW
Z-1555-2026Class IIArtelon FlexBand Plus Ref: 41054 & 41057International Life SciencesOWW
Z-1554-2026Class IIArtelon FlexBand Dynamic Matrix Ref: 31057International Life SciencesOWW
Z-1430-2026Class IIBrand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CRHitachi High-Tech Corp., KashiwanohaLHN
Z-1429-2026Class IIBrand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FRHitachi High-Tech Corp., KashiwanohaLHN
Z-1545-2026Class IOwner's Booklets and Instructions for Use that are used with the following blood glucose...Trividia Health, Inc.NBW
Z-1474-2026Class IICampy CVA Medium 100/PK, R01272Remel IncJSJ
Z-1585-2026Class IIBrand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF...Diagnostica Stago, Inc.DAP
Z-2274-2026Class IIThe Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.Fresenius Kabi USA, LLCFRN
Z-1815-2026Class IIReact Health PHOENIX 5L Oxygen Concentrator3B Medical IncCAW
Z-1491-2026Class IIBrand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein...Diagnostica Stago, Inc.GGP
Z-1590-2026Class IIImactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT)...GE HealthcareJAK
Z-1510-2026Class IIBrand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number...Exactech, Inc.HWA
Z-1509-2026Class IIBrand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog...Exactech, Inc.HWA
Z-1497-2026Class IIIBA Proton Therapy System - PROTEUS 235Ion Beam Applications S.A.LHN
Z-1572-2026Class IIMICS3 Angled Sagittal Saw Attachment; Part Number: 210490Howmedica Osteonics CorpOLO
Z-1483-2026Class IIBrand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number...B Braun Medical IncLCJ
Z-1482-2026Class IIBrand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number...B Braun Medical IncLCJ
Z-1481-2026Class IIBrand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog...B Braun Medical IncLCJ
Z-2133-2026Class IIOn-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33On-X Life Technologies Inc.LWQ
Z-1636-2026Class IITandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery...Tandem Diabetes Care, Inc.QFG
Z-1635-2026Class IIMiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61Medtronic, Inc.QFG
Z-1562-2026Class IIMedline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-1571-2026Class IICentricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that...GE HealthcareLLZ
Z-1570-2026Class IICentricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that...GE HealthcareLLZ
Z-1569-2026Class IICentricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that...GE HealthcareLLZ
Z-1557-2026Class IIHealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product...Medtronic, Inc.MWI
Z-2270-2026Class IIBrand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER...B Braun Medical IncOFT
Z-2269-2026Class IIBrand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE...B Braun Medical IncOGE