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 11 of 1187
FDA device recalls, page 11 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2752-2026Class IIFARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation CatheterBoston Scientific CorporationQZI
Z-2751-2026Class IIFARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac...Boston Scientific CorporationQZI
Z-2750-2026Class IIFARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401...Boston Scientific CorporationQZI
Z-2693-2026Class IABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP; containing...Abiomed, Inc.DYB
Z-2692-2026Class IABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP; containing Introducer...Abiomed, Inc.DYB
Z-2691-2026Class IABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code...Abiomed, Inc.DYB
Z-2690-2026Class IABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing...Abiomed, Inc.DYB
Z-2689-2026Class IABIOMED Impella CP Set, Pump Set Code 0048-0014; containing Introducer Product Code...Abiomed, Inc.DYB
Z-2688-2026Class IABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460; containing...Abiomed, Inc.DYB
Z-2687-2026Class IABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212; containing...Abiomed, Inc.DYB
Z-2686-2026Class IABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit...Abiomed, Inc.DYB
Z-2685-2026Class IABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit...Abiomed, Inc.DYB
Z-2684-2026Class IABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr...Abiomed, Inc.DYB
Z-2683-2026Class IABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing...Abiomed, Inc.DYB
Z-2682-2026Class IABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14...Abiomed, Inc.DYB
Z-2681-2026Class IABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr...Abiomed, Inc.DYB
Z-2737-2026Class IIMedline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-2736-2026Class IIMedline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2951-2026Class IIHamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to...Foundation Medicine, Inc.PQP
Z-2732-2026Class IIOrthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS REF: M122, Unilateral...Orthofix SRLKTT
Z-2731-2026Class IIOrthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS REF: M111, Unilateral...Orthofix SRLKTT
Z-2730-2026Class IIOrthofix MINIRAIL, SHORT, LENGTHENER REF: M103, Unilateral orthopedic/trauma external...Orthofix SRLKTT
Z-2729-2026Class IIOrthofix MINIRAIL, STANDARD LENGTHENER Model/Catalog Number: M101, Unilateral...Orthofix SRLKTT
Z-2724-2026Class IIICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pumpAbbott MedicalFRN
Z-2723-2026Class IIICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number...Abbott MedicalFRN
Z-2680-2026Class IAbiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer...Oscor Inc.DYB
Z-2679-2026Class IAbiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer...Oscor Inc.DYB
Z-2678-2026Class IAbiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer...Oscor Inc.DYB
Z-2717-2026Class IIBrand Name: Versius Surgical System US Product Name: Vesius Surgeon Console...CMR Surgical Inc.SCV
Z-2674-2026Class IIBrand Name: Sterile Tourniquet Hoses Product Name: A.T.S 4000 TS Tourniquet Systems...Zimmer Surgical SAKCY
Z-2673-2026Class IIBrand Name: Sterile Tourniquet Hoses Product Name: A.T.S 4000 TS Tourniquet Systems Dual...Zimmer Surgical SAKCY
Z-2866-2026Class IISTRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540Stryker Corp.GEI
Z-2865-2026Class IISTRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530Stryker Corp.GEI
Z-2864-2026Class IISTRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640Stryker Corp.GCX
Z-2863-2026Class IISTRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620Stryker Corp.GCX
Z-2862-2026Class IISTRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600Stryker Corp.GCX
Z-2774-2026Class IIPipeline Flex Embolization Device with Shield Technology, 3.00 mm x 20 mm 027 REF...Medtronic, Inc.OUT
Z-2773-2026Class IIPipeline Flex Embolization Device with Shield Technology, 3.00 mm x 12 mm 027 REF...Medtronic, Inc.OUT
Z-2802-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack...Windstone Medical Packaging, Inc.OJH
Z-2801-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack...Windstone Medical Packaging, Inc.OJG
Z-2800-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack...Windstone Medical Packaging, Inc.OGR
Z-2799-2026Class IIAMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part...Windstone Medical Packaging, Inc.LRO
Z-2787-2026Class IIMedline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18...MEDLINE INDUSTRIES, LP - NorthfieldOKV
Z-2786-2026Class IIMedline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-2785-2026Class IIMedline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-2784-2026Class IIMedline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-2783-2026Class IIMedline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-2782-2026Class IIMedline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-2781-2026Class IIMedline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2780-2026Class IIMedline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18...MEDLINE INDUSTRIES, LP - NorthfieldOHD