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 121 of 1190
FDA device recalls, page 121 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-3257-2024Class IIBiodesign Fistula Plug C-FPS-0.7-2 - For implantation to reinforce soft tissue for repair...Cook Biotech, Inc.FTM
Z-3256-2024Class IIBiodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft tissue for repair...Cook Biotech, Inc.FTM
Z-3255-2024Class IIBiodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft tissue for repair...Cook Biotech, Inc.FTM
Z-3254-2024Class IIBiodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft tissue for repair...Cook Biotech, Inc.FTM
Z-3253-2024Class IIBiodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft tissue for repair...Cook Biotech, Inc.FTM
Z-3252-2024Class IIBiodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair...Cook Biotech, Inc.FTM
Z-3251-2024Class IIBiodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair...Cook Biotech, Inc.FTM
Z-3250-2024Class IIBiodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft tissue for repair...Cook Biotech, Inc.FTM
Z-2972-2024Class IInfusomat Space Infusion System/ Large Volume Pump, Product Code 8713050UB Braun Medical IncFRN
Z-3123-2024Class IIFilmarray Torch Module Box, Htfa-Asy-0003, Htfa-Asy-0003-W, Htfa-Asy-0003UBioFire Diagnostics, LLCOCC
Z-3122-2024Class IIFilmarray 2.0 Instrument, Ref: Flm2-Asy-0001, Flm2-Asy-0001-WBioFire Diagnostics, LLCNSU
Z-3154-2024Class IIGeneral Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number...Cypress Medical Products LLCFMF
Z-2953-2024Class IIPhilips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional...Philips Medical Systems Nederland B.V.OWB
Z-3214-2024Class IIGE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.GE HealthcareLLZ
Z-0037-2025Class IIThe EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to...Quantum Surgical SASJAK
Z-3157-2024Class IIERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a...Terumo Cardiovascular Systems CorporationNRY
Z-2971-2024Class IIImpella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;Abiomed, Inc.OZD
Z-2970-2024Class IIImpella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;Abiomed, Inc.OZD
Z-2969-2024Class IIImpella CP Smart Assist Set; Product Code: 1000402;Abiomed, Inc.OZD
Z-2968-2024Class IIImpella 5.5 Set AU; Product Code: 1000361;Abiomed, Inc.OZD
Z-2967-2024Class IIImpellaCP SmartAssistSetAPAC, Delo1895; Product Code: 1000302;Abiomed, Inc.OZD
Z-2966-2024Class IIImpella 5.5 SmartAssist Set, JP; Product Code: 1000211;Abiomed, Inc.OZD
Z-2965-2024Class IIImpella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;Abiomed, Inc.OZD
Z-2964-2024Class IIPump 381 Pump Set (US); Product Code: 1000080;Abiomed, Inc.OZD
Z-2963-2024Class IIImpella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;Abiomed, Inc.OZD
Z-2962-2024Class IIImpella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;Abiomed, Inc.OZD
Z-2961-2024Class IIImpella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002;Abiomed, Inc.OZD
Z-2960-2024Class IIImpella CP Smart Assist Set APAC; Product Code: 0048-0047;Abiomed, Inc.OZD
Z-2959-2024Class IIPump 371 14F LT CMR Set; Product Code: 0048-0045;Abiomed, Inc.OZD
Z-2958-2024Class IIImpella CP Smart Assist Set, Canada; Product Code: 0048-0044;Abiomed, Inc.OZD
Z-2957-2024Class IIImpella CP Pump 371 Set, Clinical Trial; Product Code: 0048-0040;Abiomed, Inc.OZD
Z-2956-2024Class IIImpella CP Pump Set, Japan; Product Code: 0048-0034-JP;Abiomed, Inc.OZD
Z-2955-2024Class IIImpella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;Abiomed, Inc.OZD
Z-2954-2024Class IIImpella CP Smart Assist Set, EU; Product Code: 0048-0014;Abiomed, Inc.OZD
Z-2732-2024Class IICustom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient...Howmedica Osteonics CorpJDI
Z-0052-2025Class IIMonarch Platform (Urology), REF: MON-000007, MON-000007-RFBAuris Health, IncFGB
Z-0051-2025Class IIMonarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform...Auris Health, IncEOQ
Z-3068-2024Class IIBrand Name: Transcend Product Name: Transcend Singles Universal Body (UB) Refill...Ultradent Products Inc.EBF
Z-3067-2024Class IIBrand Name: Transcend Product Name: Transcend Econo Kit (UB) - Singles Model/Catalog...Ultradent Products Inc.EBF
Z-3066-2024Class IIBrand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3 Model/Catalog Number...Ultradent Products Inc.EBF
Z-3206-2024Class IIBARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN...Bard Peripheral Vascular IncFCG
Z-0019-2025Class IITablo Console, REF: PN-0003000, PN-0006000, part of the Tablo Hemodialysis System. The...Outset Medical, Inc.KDI
Z-3162-2024Class IIMarodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting...Btt Health GmbHBXB
Z-3295-2024Class IIAGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered (PC) and...Boston Scientific CorporationESW
Z-3294-2024Class IIAGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and...Boston Scientific CorporationESW
Z-3293-2024Class IIAGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and...Boston Scientific CorporationESW
Z-3292-2024Class IIAGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and...Boston Scientific CorporationESW
Z-3291-2024Class IIAGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and...Boston Scientific CorporationESW
Z-3290-2024Class IIAGILE ESO OTW PC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and...Boston Scientific CorporationESW
Z-3289-2024Class IIAGILE ESO OTW PC 23MM X 12.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and...Boston Scientific CorporationESW