510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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

59,486 records, page 352 of 1190
FDA device recalls, page 352 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1678-2020Class IIMEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2...Siemens Medical Solutions USA, Inc.IYE
Z-1677-2020Class IIARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software...Siemens Medical Solutions USA, Inc.IYE
Z-1683-2020Class IIFirefly Floorsitter, Firefly Splashy Bathseat, Firefly GoTo Seat - Product Usage: The...James Leckey Design LtdILS
Z-1523-2020Class IICustom procedure trays containing medical components needed to facilitate patient...Avid Medical, Inc. a Medical Action Ind. Company 305OJH
Z-1522-2020Class IICustom procedure trays containing medical components needed to facilitate patient...Avid Medical, Inc. a Medical Action Ind. Company 305OKV
Z-1521-2020Class IICustom procedure trays containing medical components needed to facilitate patient...Avid Medical, Inc. a Medical Action Ind. Company 305OJK
Z-1520-2020Class IICustom procedure trays containing medical components needed to facilitate patient...Avid Medical, Inc. a Medical Action Ind. Company 305OJG
Z-1519-2020Class IICustom procedure trays containing medical components needed to facilitate patient...Avid Medical, Inc. a Medical Action Ind. Company 305OGJ
Z-1518-2020Class IICustom procedure trays containing medical components needed to facilitate patient...Avid Medical, Inc. a Medical Action Ind. Company 305OGD
Z-1517-2020Class IICustom procedure trays containing medical components needed to facilitate patient...Avid Medical, Inc. a Medical Action Ind. Company 305OEZ
Z-1516-2020Class IICustom procedure trays containing medical components needed to facilitate patient...Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-1515-2020Class IICustom procedure trays containing medical components needed to facilitate patient...Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-1547-2020Class IIChemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This...Randox Laboratories, LimitedJJY
Z-2033-2020Class IIAB HiResolution Bionic Ear System, HiRes Ultra CI, MS Electrode - Product Usage: The...Advanced Bionics LLCMCM
Z-2032-2020Class IIAB HiResolution Bionic Ear System, HiRes Ultra 3D CI, HiFocus SlimJ Electrode - Product...Advanced Bionics LLCMCM
Z-1543-2020Class IIComprehensive Shoulder System Mini Humeral Stem 9mm,, Model No. 113629 - Product Usage...Zimmer GmbHMBF
Z-1535-2020Class IIiChemVELOCITY Strips, Catalog 800-7212Siemens Healthcare Diagnostics Inc.KQO
Z-1927-2020Class IIThe Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF...Abbott MedicalDXG
Z-1528-2020Class Iev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological...Medtronic, Inc.OUT
Z-1527-2020Class Iev3 Pipeline Flex Embolization Device. For neurological endovascular use.Medtronic, Inc.OUT
Z-1497-2020Class IIArtis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee...Siemens Medical Solutions USA, Inc.OWB
Z-1496-2020Class IIArtis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis...Siemens Medical Solutions USA, Inc.OWB
Z-1495-2020Class IIArtis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor...Siemens Medical Solutions USA, Inc.OWB
Z-1599-2020Class IIAtellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI...Siemens Healthcare Diagnostics Inc.DIC
Z-1554-2020Class IINaviCare Patient Safety Software Versions 3.5.400-3.9.300. The NaviCare Patient Safety...Hill-Rom Inc.KMI
Z-1898-2020Class IINUVASIVE MAGEC 2 Rod X.X mm XX mm, REF MC2-XXXXS LOT 0000000 AAA - Product Usage...NuVasive IncPGN
Z-2068-2020Class IIDFINE Vertebral Assemblies: Hydraulic-Master Syringe Assembly, StabiliT Vertebral...Merit Medical Systems, Inc.OAR
Z-2067-2020Class IIDFINE Vertebral Hydraulic Assemblies: Hydraulic Assembly, StabiliT Vertebral Augmentation...Merit Medical Systems, Inc.OAR
Z-1947-2020Class IIQuickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered...Sunrise Medical, Inc.ITI
Z-1541-2020Class IIDimension Vista Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the...Siemens Healthcare Diagnostics Inc.CIG
Z-1540-2020Class IIDimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the...Siemens Healthcare Diagnostics Inc.CIG
Z-1539-2020Class IIADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL)...Siemens Healthcare Diagnostics Inc.JFM
Z-1538-2020Class IIADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL)...Siemens Healthcare Diagnostics Inc.JFM
Z-1537-2020Class IIAtellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total...Siemens Healthcare Diagnostics Inc.JFM
Z-1536-2020Class IIAtellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct...Siemens Healthcare Diagnostics Inc.JFM
Z-1553-2020Class IIOmnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D...Insulet CorporationLZG
Z-1512-2020Class IIBoston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152...Boston Scientific CorporationLWS
Z-1511-2020Class IIBoston Scientific, LATITUDE Programming System, Model 3300 - Product Usage:The Boston...Boston Scientific CorporationLWS
Z-1691-2020Class IIMicrobiologics QC SETS AND PANELS, YST Comprehensive QC Set, REF 5195P, containing...Microbiologics, Inc.JTR
Z-1690-2020Class IIKWIK-STIK 2 Pack Trichosporon dermatis derived from ATCC 204094 (Catalog# 0778P, lot...Microbiologics, Inc.JTR
Z-1458-2020Class IINextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF...Medartis AGHWC
Z-1699-2021Class IINexSite HD, Hemodialysis Symmetric Tip Catheter for long term useMarvao Medical Devices Ltd.MSD
Z-2083-2020Class IINelDerm Hydrogel Dressing (Dressing: 6 x 6 ; Pad: 4 x 4 ) Product #: HB66TNelson Innovaions, LLCNAE
Z-1533-2020Class IIMedtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mmMedtronic, Inc. (Minneapolis, MN 55447)LWQ
Z-1559-2020Class IIIntellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product...Intellijoint Surgical Inc.OLO
Z-1555-2020Class IImager II 5F Angiographic Catheters, 5 units per package.Boston Scientific CorporationDQO
Z-1701-2020Class IISpice (Jwh-018) Cc443Carolina Liquid ChemistriesLDJ
Z-1546-2020Class IIMedline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G1A lot...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1545-2020Class IIMedline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration 06/30/2022.MEDLINE INDUSTRIES, LP - NorthfieldOJU
Z-1544-2020Class IIMedline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expiration...MEDLINE INDUSTRIES, LP - NorthfieldOJU