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 85 of 1190
FDA device recalls, page 85 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1702-2025Class IITibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12...Waldemar Link GmbH & Co. KGJWH
Z-1701-2025Class IIL-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2)...Waldemar Link GmbH & Co. KGJWH
Z-1700-2025Class IIPosterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2)...Waldemar Link GmbH & Co. KGJWH
Z-1699-2025Class IIDistal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2)...Waldemar Link GmbH & Co. KGJWH
Z-1739-2025Class IIAtalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions...WandercraftPHL
Z-1657-2025Class IIMAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;Globus Medical, Inc.PGN
Z-1987-2025Class IIBiomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled...PREAT CorporationNHA
Z-1721-2025Class IIWasher Disinfector Aquadis 56; Model Number: 56MGetinge Disinfection ABMEC
Z-1720-2025Class IIWasher Disinfector Aquadis 56; Model Number: 56AGetinge Disinfection ABMEC
Z-1683-2025Class IIHistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version...Leica Biosystems Melbourne Pty LtdIEO
Z-1660-2025Class IIPhilips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray...Philips North America LLCJAK
Z-1703-2025Class IImyQA iON; Article Number: MQ10-000;IBA Dosimetry GmbHIYE
Z-1743-2025Class IIHalyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.Avid Medical, Inc. a Medical Action Ind. Company 305OEZ
Z-1742-2025Class IIHalyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.Avid Medical, Inc. a Medical Action Ind. Company 305OEZ
Z-1741-2025Class IIHalyard CHRIST SUTURE KIT. General Procedure Tray Convenience KitAvid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-1859-2025Class IIUltrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number...Ultra Clean Systems, Inc.FLG
Z-1676-2025Class IIStraight Inflow/Bifurcated Outflow Line Kit. Model Number: 902-00038. Sterile...Belmont Medical TechnologiesLGZ
Z-1673-2025Class IIStratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.Siemens Healthcare Diagnostics Inc.JHX
Z-1678-2025Class II3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032...Belmont Medical TechnologiesLGZ
Z-1675-2025Class IIStraight Inflow/Outflow Patient Line Kit. Model Number: 902-00037. Sterile...Belmont Medical TechnologiesLGZ
Z-1674-2025Class IIHyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use...Belmont Medical TechnologiesLGZ
Z-1579-2025Class IIBrand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number...Micro-X Ltd.IZL
Z-1621-2025Class IIGuide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S;Stryker Corp.LXH
Z-1620-2025Class IIGuide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S;Stryker Corp.LXH
Z-1578-2025Class IIBrand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number...Micro-X Ltd.IZL
Z-1737-2025Class IIIntroducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15...Galt Medical CorpOFL
Z-1736-2025Class IIIntroducer Needle REF NDL-107-04 These needles are used for the percutaneous...Galt Medical CorpDWS
Z-1735-2025Class IIIntroducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34...Galt Medical CorpOFL
Z-1734-2025Class IIGALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous...Galt Medical CorpDQX
Z-1733-2025Class IIB Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model...Galt Medical CorpDYB
Z-1732-2025Class IIB Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37...Galt Medical CorpDRE
Z-1731-2025Class IIGALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in...Galt Medical CorpKGZ
Z-1680-2025Class IIntraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL...Bausch & Lomb IncorporatedMFK
Z-1679-2025Class IIntraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL...Bausch & Lomb IncorporatedHQL
Z-1663-2025Class IISkytron Freedom 4FXS-60 Heavy Duty Monitor MountIhb OperationsFQO
Z-1664-2025Class IIBeckman Coulter DxI 9000 Access Immunoassay AnalyzerSiemens Healthcare Diagnostics Inc.JJE
Z-1661-2025Class IIThe Trimble RTS873 robotic total station is a solution designed for construction...Trimble ABREP
Z-1569-2025Class IIrestor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number...ConforMIS, Inc.LPH
Z-1948-2025Class IIBrand Name: Solana Bordetella Complete Assay Product Name: Solana Bordetella...Ortho-Clinical Diagnostics, Inc.OZZ
Z-1783-2025Class IISmartPath to dStream for 3.0T, Model Number: 782145;Philips Medical Systems Nederland B.V.LNH
Z-1782-2025Class IISmartPath to dStream for 1.5T, Model Number: 782146;Philips Medical Systems Nederland B.V.LNH
Z-1781-2025Class IIIntera CV, Model Number: 781107;Philips Medical Systems Nederland B.V.LNH
Z-1780-2025Class IIIntera 3.0T Quasar Dual, Model Number: 781150;Philips Medical Systems Nederland B.V.LNH
Z-1779-2025Class IIIntera 1.5T R11, Model Number: 781170;Philips Medical Systems Nederland B.V.LNH
Z-1778-2025Class IIIntera 1.5T Power/Pulsar, Model Number: 781105;Philips Medical Systems Nederland B.V.LNH
Z-1777-2025Class IIIntera 1.5T Omni/Stellar, Model Number: 781104;Philips Medical Systems Nederland B.V.LNH
Z-1776-2025Class IIIntera 1.5T Master/Nova, Model Number: 781106;Philips Medical Systems Nederland B.V.LNH
Z-1775-2025Class IIIntera 1.5T Explorer/Nova Dual, Model Number: 781108;Philips Medical Systems Nederland B.V.LNH
Z-1774-2025Class IIIntera 1.5T, Model Numbers: 781195 and 781295;Philips Medical Systems Nederland B.V.LNH
Z-1773-2025Class IIIntera 1.0T Power/Pulsar, Model Number: 781103;Philips Medical Systems Nederland B.V.LNH