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 181 of 1190
FDA device recalls, page 181 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0124-2024Class I8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric Infusion...B Braun Medical IncFRN
Z-0123-2024Class I8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump SystemB Braun Medical IncFRN
Z-0150-2024Class IMonoject" 60 mL Syringe Luer-Lock Tip Soft PackMedtronic, Inc.FMF
Z-0149-2024Class IMonoject" 35 mL Syringe Luer-Lock Tip Soft PackMedtronic, Inc.FMF
Z-0148-2024Class IMonoject 20 mL Syringe Luer-Lock Tip Soft PackMedtronic, Inc.FMF
Z-0147-2024Class IMonoject" 12 mL Syringe Luer-Lock Tip Soft PackMedtronic, Inc.FMF
Z-0146-2024Class IMonoject" 6 mL Syringe Luer-Lock Tip Soft PackMedtronic, Inc.FMF
Z-0145-2024Class IMonoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft PackMedtronic, Inc.FMF
Z-2114-2025Class IINeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2...NeuroSync, Inc.QEA
Z-0210-2024Class IIVasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 printed on...Maquet Cardiovascular LLCGEI
Z-0219-2024Class IILeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the...Magellan Diagnostics, Inc.DOF
Z-0295-2024Class IIIBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS...Ion Beam Applications S.A.LHN
Z-0318-2024Class IIExpress Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N...Atrium Medical CorporationCAC
Z-0317-2024Class IIOasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE...Atrium Medical CorporationCAC
Z-0316-2024Class IIOcean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000...Atrium Medical CorporationCAC
Z-0208-2024Class IINova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in...Nova Biomedical CorporationJGS
Z-0207-2024Class IINova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum...Nova Biomedical CorporationJGS
Z-0116-2024Class IIDeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kitDeRoyal Industries, Inc.LRO
Z-0170-2024Class ISenhance Surgical System, which includes: Manipulator Arm, ISU Configuration ( Catalog...Asensus Surgical, Inc.NAY
Z-0186-2024Class IAlaris PCA Module 8120CareFusion 303, IncFRN
Z-0185-2024Class IBD Alaris Syringe Module, REF 8110CareFusion 303, IncFRN
Z-0184-2024Class IBD Alaris PCU REF 8015CareFusion 303, IncFRN
Z-0113-2024Class IIstryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset...TORNIER Inc.PHX
Z-1371-2024Class IIAptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001...Hologic, Inc.PAB
Z-0056-2025Class IIEVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS...OLYMPUS Corporation of the AmericasFDF
Z-0140-2024Class IICentricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological...GE HealthcareLLZ
Z-0139-2024Class IICentricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation...GE HealthcareLLZ
Z-0138-2024Class IICentricity PACS-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image...GE HealthcareLLZ
Z-0287-2024Class IIStryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler...Stryker Corp.KDD
Z-0111-2024Class IAstral 100 and Astral 150 ventilatorsResMed CorpCBK
Z-0231-2024Class IIBREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid.Breg IncITJ
Z-0137-2024Class IIMaquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac...Maquet Cardiovascular LLCMWS
Z-0112-2024Class IIMonoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code...Medtronic, Inc.FMF
Z-0236-2024Class IIVITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per...Ortho-Clinical Diagnostics, Inc.CHI
Z-0206-2024Class IIRayCare 5B and 6A including service packs- An oncology information system used to support...RaySearch Laboratories AB (publ)MUJ
Z-0196-2024Class II***Updated 12/4/23*** (1) Cios Flow (VA30) mobile fluoroscopic C-arm X-ray System...Siemens Medical Solutions USA, Inc.OWB
Z-0195-2024Class IISiemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the...Siemens Medical Solutions USA, Inc.OWB
Z-0110-2024Class IIBD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023Becton Dickinson & CoMDB
Z-0109-2024Class IITHUNDERBEAT, 5MM, 45CM, Front-actuated Grip Type S Model: TB-0545FCS Indicated for open...OLYMPUS Corporation of the AmericasLFL
Z-0108-2024Class IITHUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicated for open...OLYMPUS Corporation of the AmericasLFL
Z-0107-2024Class IIDxI 9000 Access Immunoassay Analyzer, REF C11137, Sofware Versions 1.15 and below...Siemens Healthcare Diagnostics Inc.JJE
Z-0257-2024Class IIDisposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number...Stryker Corp.GEI
Z-0256-2024Class IIDisposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number...Stryker Corp.GEI
Z-0255-2024Class IIDisposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number...Stryker Corp.GEI
Z-0254-2024Class IIDisposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number...Stryker Corp.GEI
Z-0253-2024Class IIDisposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number...Stryker Corp.GEI
Z-0252-2024Class IIDisposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog Number...Stryker Corp.GEI
Z-0251-2024Class IIDisposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number...Stryker Corp.GEI
Z-0250-2024Class IIDisposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number...Stryker Corp.GEI
Z-0249-2024Class IIDisposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number...Stryker Corp.GEI