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 78 of 1190
FDA device recalls, page 78 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2118-2025Class IIBrand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number...Waismed Ltd.FMI
Z-2324-2025Class IIIZvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10Diversatek Healthcare IncFFX
Z-2265-2025Class IIIBrand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number...DRG International, Inc.CDX
Z-2134-2025Class IIAzurion 7 M20. Fluoroscopic X-Ray System.Philips Medical Systems Nederland B.V.OWB
Z-1982-2025Class IIUROSKOP Omnia Max. Model Number: 10762473Siemens Medical Solutions USA, Inc.JAA
Z-1981-2025Class IIUROSKOP Omnia. Model Number: 10094910Siemens Medical Solutions USA, Inc.JAA
Z-2089-2025Class IIADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)Siemens Healthcare Diagnostics Inc.JCN
Z-2088-2025Class IIADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)Siemens Healthcare Diagnostics Inc.JCN
Z-2087-2025Class IIADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)Siemens Healthcare Diagnostics Inc.JCN
Z-2086-2025Class IIADVIA 120/2120/2120i SETpoint CalibratorSiemens Healthcare Diagnostics Inc.KRZ
Z-2328-2025Class IHamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton...Hamilton Medical AGCBK
Z-2047-2025Class IBravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to...Given Imaging Ltd.FFT
Z-2076-2025Class IIREF: 123400,Bard Urologist's Tray, For the Obstructed UrethraC.R. Bard IncEZC
Z-2075-2025Class IIBD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr...C.R. Bard IncKOD
Z-2074-2025Class IIBD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr...C.R. Bard IncKOD
Z-2079-2025Class IIREF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for...Becton, Dickinson and Company, BD BiosciencesGKZ
Z-2078-2025Class IIREF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow...Becton, Dickinson and Company, BD BiosciencesGKZ
Z-2116-2025Class IISwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000...Abbott MedicalQBP
Z-2513-2025Class IIMedshape Universal Joints, REF: DNE-9000-UJMedshape, Inc.KTT
Z-2126-2025Class IIBrand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L...Encore Medical, LPJWH
Z-2125-2025Class IIBrand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L...Encore Medical, LPJWH
Z-2175-2025Class IIInseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part...Remote Diagnostic Technologies Ltd.MHX
Z-2515-2025Class IIPlatelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM...Bio-Rad Laboratories Inc.LGD
Z-2015-2025Class IServo-u MR Ventilator System. Model Number: 6888800.Maquet Critical Care ABCBK
Z-2014-2025Class IServo-n Ventilator System. Model Number: 6694800.Maquet Critical Care ABCBK
Z-2013-2025Class IServo-u Ventilator System. Model Number: 6688600.Maquet Critical Care ABCBK
Z-2032-2025Class IHillrom LikoScale component, Product Code 3156232, used with the following adapter kits...Baxter Healthcare CorporationFSA
Z-2031-2025Class IHillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient...Baxter Healthcare CorporationFSA
Z-2034-2025Class IISpectral CT. Computed tomography X-ray system.Philips North America LLCJAK
Z-1936-2025Class IISmartPath to dStream for 1.5T; Product Number: 782146;Philips North America LLCLNH
Z-1935-2025Class IIIntera Achieva 1.5T Pulsar; Product Number: 781171;Philips North America LLCLNH
Z-1934-2025Class IIIntera 1.5T Omni/Stellar; Product Number: 781104;Philips North America LLCLNH
Z-1933-2025Class IIIntera 1.5T Master/Nova Product Number: 781106;Philips North America LLCLNH
Z-1932-2025Class IIIntera 1.5T Explorer/Nova Dual Product Number: 781108;Philips North America LLCLNH
Z-1931-2025Class IIIntera 1.5T Achieva Nova-Dual Product Number: 781173;Philips North America LLCLNH
Z-1930-2025Class IIIntera 1.5T Achieva Nova Product Number: 781172;Philips North America LLCLNH
Z-1929-2025Class IIIntera 1.5T Achieva IT Nova Product Number: 781175Philips North America LLCLNH
Z-1928-2025Class IIAchieva XR Product Numbers: (1) 781153, (2) 781253;Philips North America LLCLNH
Z-2188-2025Class IILIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50...Terumo Cardiovascular Systems CorporationKRD
Z-2068-2025Class IIPhilips XL14-3 Transducer.Philips North America LLCITX
Z-2067-2025Class IIPhilips X8-2t Transducer.Philips North America LLCITX
Z-2066-2025Class IIPhilips X7-2t Transducer.Philips North America LLCITX
Z-2065-2025Class IIPhilips X6-1 Transducer.Philips North America LLCITX
Z-2064-2025Class IIPhilips X5-1 Transducer.Philips North America LLCITX
Z-2063-2025Class IIPhilips VL13-5 Transducer.Philips North America LLCITX
Z-2062-2025Class IIPhilips V6-2 Transducer.Philips North America LLCITX
Z-2061-2025Class IIPhilips S8-3t Transducer.Philips North America LLCITX
Z-2060-2025Class IIPhilips S7-3t Transducer.Philips North America LLCITX
Z-2059-2025Class IIPhilips S7-2 Transducer.Philips North America LLCITX
Z-2058-2025Class IIPhilips S5-1 Transducer.Philips North America LLCITX