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 174 of 1190
FDA device recalls, page 174 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0560-2024Class IIRoche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System...Inpeco S.p.A.CEM
Z-0559-2024Class IIPhilips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079...Philips Medical Systems Nederland B.V.OWB
Z-0558-2024Class IIPhilips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper...Philips Medical Systems Nederland B.V.OWB
Z-0421-2024Class IIICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac MonitorMedtronic, Inc.MXD
Z-0531-2024Class IISterile Povidone, Ref Dynda2061MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0530-2024Class IISterile Betadine, Ref Dynda1998MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0529-2024Class IIPvp Solution Sing Strl, Ref Dynda1858MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0528-2024Class IISterile Pvp, Ref Dynda1649MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0527-2024Class IISterile Sterile Prep Stick, Ref Dynda1134MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0526-2024Class IISterile Pvp Sln Kit, Ref Dyndm1097MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0525-2024Class IISterile Pvp Solution, Ref Dynda1907MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-0487-2024Class IIRemington MEDICAL Drainage Bag, REF 600-D;Remington MedicalEXF
Z-0463-2024Class IIQUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; used to dilate...Wilson-Cook Medical Inc.FGE
Z-0462-2024Class IIQUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate...Wilson-Cook Medical Inc.FGE
Z-0461-2024Class IIQUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate...Wilson-Cook Medical Inc.FGE
Z-0460-2024Class IIQUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate...Wilson-Cook Medical Inc.FGE
Z-0459-2024Class IIQUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate...Wilson-Cook Medical Inc.FGE
Z-0458-2024Class IIQUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate...Wilson-Cook Medical Inc.FGE
Z-0457-2024Class IIQUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate...Wilson-Cook Medical Inc.FGE
Z-0506-2024Class IIMulti-Mode Stimulator, Transcutaneous Electrical Nerve StimulationLiberty Medical Solutions, LLCIPF
Z-0998-2024Class IISperm separation media are used to separate motile sperm from other constituents of semen.FUJIFILM Biosciences Inc.MQL
Z-0570-2024Class IIBiolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02Zimmer GmbHLZO
Z-0569-2024Class IIBiolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01Zimmer GmbHLZO
Z-1967-2025Class IIBrand Name: Guardian 2 System Product Name: Guardian System 2 Controller Model/Catalog...Turncare, IncFNM
Z-0610-2024Class IILITe Decompression Snake Arm, REF 48080230Howmedica Osteonics CorpLXH
Z-0621-2024Class IIAtrium Oasis Drain Single W / AC, Part No. 3600-100Atrium Medical CorporationCAC
Z-0551-2024Class IIChange Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of...Change Healthcare Canada CompanyLLZ
Z-0314-2024Class IIBlood Culture Kit, Ref Dyndh1647bMEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-0313-2024Class II24 Blood Culture Kit, Ref Dyndh1632MEDLINE INDUSTRIES, LP - NorthfieldGJE
Z-0312-2024Class IICentral Line Blood Culture Dra, Ref Dyndh1562MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-0311-2024Class IIPeripheral Blood Culture Draw, Ref Dyndh1561MEDLINE INDUSTRIES, LP - NorthfieldMCY
Z-0310-2024Class IIAdlt Blood Culture Collect Kit, Ref Dyndh1245MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0355-2024Class IInfusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with...B Braun Medical IncFPA
Z-0603-2024Class IIZEUS ELISA Parvovirus B19 IgM Test System, Product Number SM9Z7701GZeus Scientific LLCMYL
Z-0602-2024Class IIZEUS ELISA Parvovirus B19 IgG Test System, Product Number SM9Z7701MZeus Scientific LLCMYL
Z-0589-2024Class IIAcrobat-i Vacuum Positioner System, Model Number XP-5000ZMaquet Cardiovascular LLCMWS
Z-0483-2024Class IIPUMP MCS1705PU HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT US, Model Number...HeartWare, Inc.DSQ
Z-0482-2024Class IIHVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT/IMPLANT KIT OUS, Model...HeartWare, Inc.DSQ
Z-0481-2024Class IIPUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT EN JA, Model Number...HeartWare, Inc.DSQ
Z-0480-2024Class II1104CA-CLIN - HVAD (HeartWare Ventricular Assist Device) PUMP, Model Number 1104CA-CLINHeartWare, Inc.DSQ
Z-0479-2024Class IIPUMP 1104 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1104HeartWare, Inc.DSQ
Z-0478-2024Class IIPUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103HeartWare, Inc.DSQ
Z-0477-2024Class IIHVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102HeartWare, Inc.DSQ
Z-0476-2024Class IISTERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101HeartWare, Inc.DSQ
Z-0475-2024Class IIHVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1100HeartWare, Inc.DSQ
Z-0516-2024Class IIThe 4Kscore Test, an in vitro serum or plasma test that combines the results of four...BioReference Health, LLCQRF
Z-0651-2025Class IISmall DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come...Folsom Metal Products, Inc.HAE
Z-0650-2025Class IIDKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in...Folsom Metal Products, Inc.HAE
Z-0789-2024Class IISnapshot NIR, REF: KD204Kent Imaging IncMUD
Z-0407-2024Class IIAlinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m...Abbott Molecular, Inc.MZP