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 135 of 1190
FDA device recalls, page 135 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2598-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS...Abbott MedicalBTO
Z-2597-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE...Abbott MedicalBTO
Z-2596-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM...Abbott MedicalBTO
Z-2595-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM...Abbott MedicalBTO
Z-2594-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT...Abbott MedicalBTO
Z-2593-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND...Abbott MedicalBTO
Z-2592-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE...Abbott MedicalBTO
Z-2591-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product...Abbott MedicalBTO
Z-2590-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE...Abbott MedicalBTO
Z-2589-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM...Abbott MedicalBTO
Z-2588-2024Class IPORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM...Abbott MedicalBTO
Z-2330-2024Class IIPresource kits and trays, labeled as: 1) Neurological Tray, Catalog Number SAN29NICCA...Medtronic, Inc.OJG
Z-2329-2024Class IIPresource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number...Medtronic, Inc.OEZ
Z-2328-2024Class IIPresource kits and trays, labeled as: 1) Cardiac Catheterization Kit, Catalog Number...Medtronic, Inc.OES
Z-2327-2024Class IIPresource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605...Medtronic, Inc.OEQ
Z-2273-2024Class IIALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5Maquet Cardiovascular Us Sales, LLCFQO
Z-2272-2024Class IIALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5Maquet Cardiovascular Us Sales, LLCFQO
Z-2271-2024Class IIALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4Maquet Cardiovascular Us Sales, LLCFQO
Z-2167-2024Class IICUSA Excel C2600 23KHz Straight Handpiece-Indicated for use in surgical procedures where...Integra LifeSciences CorporationLFL
Z-2140-2024Class ILife2000 Ventilator, Product Code: MS-01-0118, which is contained in the Life2000...Baxter Healthcare CorporationCBK
Z-2532-2024Class II(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved...Artivion, Inc.DXZ
Z-2531-2024Class IICryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart...Artivion, Inc.OHA
Z-3127-2024Class IIBrand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version...Hitachi High-Tech America, Inc. Radiation Therapy DivisionLHN
Z-3126-2024Class IIBrand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version...Hitachi High-Tech America, Inc. Radiation Therapy DivisionLHN
Z-3125-2024Class IIBrand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version...Hitachi High-Tech America, Inc. Radiation Therapy DivisionLHN
Z-2428-2024Class IIBeckman Coulter, REF: OSR61173, IGM 4x14 mL R1, 4x11 mL R2Siemens Healthcare Diagnostics Inc.CFN
Z-0091-2025Class IICue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for...Cue Health, Inc.QWB
Z-2243-2024Class IIWOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation fluid to the...Novanta Medical GmbHHRX
Z-2412-2024Class IISurgical Image Guidance Functionality, software used with NGENUITY 3D Visualization...Alcon LaboratoriesFWJ
Z-2153-2024Class IIGray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910Howmedica Osteonics CorpLXH
Z-2152-2024Class IIHRIS Storage & Sterilization Case and Tray, Catalog/Part Number: 6210-9-900Howmedica Osteonics CorpLXH
Z-2544-2024Class IIBeckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.Siemens Healthcare Diagnostics Inc.JJE
Z-2735-2024Class IIDxI 9000 Access Immunoassay Analyzer, Catalog #C11137.Siemens Healthcare Diagnostics Inc.JJE
Z-2411-2024Class IIEndo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W...Waldemar Link GmbH & Co. KGJWH
Z-2410-2024Class IIEndo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01...Waldemar Link GmbH & Co. KGJWH
Z-2432-2024Class IIAbbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx OnlyAbbott MedicalMHY
Z-2431-2024Class IIAbbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx OnlyAbbott MedicalMHY
Z-2430-2024Class IIAbbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx OnlyAbbott MedicalMHY
Z-2429-2024Class IIAbbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx OnlyAbbott MedicalMHY
Z-2239-2024Class IIAvalon Ultrasound Transducer. Directs low-energy ultrasound beam toward the fetal heart...Philips North America LLCHGM
Z-2218-2024Class IIPrelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S0...Merit Medical Systems, Inc.DYB
Z-2215-2024Class II2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411...Thoratec Switzerland GmbHDSQ
Z-2267-2024Class IIIsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100Boston Scientific CorporationPCT
Z-2266-2024Class IIVITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product...Ortho-Clinical Diagnostics, Inc.PPM
Z-2262-2024Class IIBD Alaris System Manager REF: 9601, compatible with BD Alaris PC UnitsCareFusion 303, IncFRN
Z-2269-2024Class IIPink Luminous Breast, Breast transilluminatorSilkprousa LLCLEK
Z-2349-2024Class IICascade IOMAX Cortical Module, REF: 190296-200Cadwell Industries IncGWF
Z-2235-2024Class IIBrand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog...SeaSpine Orthopedics CorporationGAD
Z-2234-2024Class IIBrand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog...SeaSpine Orthopedics CorporationGAD
Z-2179-2024Class IIRingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip...Zimmer GmbHJDI