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 141 of 1190
FDA device recalls, page 141 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2021-2024Class IIBrand Name: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product...Verathon Inc.CCW
Z-1880-2024Class IArrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF...Arrow International LLC (subsidiary of Teleflex Incorporated)DSP
Z-1879-2024Class IArrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF...Arrow International LLC (subsidiary of Teleflex Incorporated)DSP
Z-1878-2024Class IArrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF...Arrow International LLC (subsidiary of Teleflex Incorporated)DSP
Z-2025-2024Class IIBSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside...Nihon Kohden America IncMHX
Z-2220-2024Class IICDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-11Centers for Disease Control and PreventionOZE
Z-2236-2024Class IIAcumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a)...Exactech, Inc.KWY
Z-2026-2024Class IIO-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic and 3D imaging...Medtronic Navigation, IncOWB
Z-1916-2024Class IISTARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or...Synthes (USA) Products LLCHXX
Z-2038-2024Class IIEsoFLIP, 30mm BALLOON DILATION CATHETER, REF ES-330, Rx OnlyMedtronic, Inc.PID
Z-2332-2024Class IIMNA-420 ENC HDMI, Material Number K9303311; cathode ray tube displayBarco N.V.DXJ
Z-2233-2024Class IIEasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4K- The...OLYMPUS Corporation of the AmericasNAY
Z-1901-2024Class IIsmith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and...Smith & Nephew, Inc.LZO
Z-1900-2024Class IIBrand Name: EsophaCap Product Name: EsophaCap (25mm diameter, 10...Lucid Diagnostics, Inc.EOX
Z-1899-2024Class IIBrand Name: EsophaCap Product Name: EsophaCap (20mm diameter, 20...Lucid Diagnostics, Inc.EOX
Z-2039-2024Class IICoviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into or withdraw fluids...Mckesson Medical-Surgical Inc. Corporate OfficeFMF
Z-1882-2024Class IICascade IOMAX Cortical Module, REF: 190296-200Cadwell Industries IncGWF
Z-1881-2024Class IISURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.Ethicon, IncLMF
Z-1887-2024Class IIIMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test...Siemens Healthcare Diagnostics Inc.JZO
Z-1886-2024Class IIIMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test...Siemens Healthcare Diagnostics Inc.JZO
Z-1909-2024Class IISynchro .014"guide wire, 35 cm tip, Catalog: M00313010 Synchro .014 guide wire, 300 cm...Stryker Corp.DQX
Z-1908-2024Class IIDAC 044 115cm, Catalog: 90760Stryker Corp.DQY
Z-1907-2024Class IIFlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495Stryker Corp.DQY
Z-1906-2024Class IITrevo Trak 21 Microcatheter, Catalog: 90338Stryker Corp.QJP
Z-1905-2024Class IITrevo NXT ProVue 3 x 32, US, Catalog: 90312 Kits: TREVO NXT 3X32+TRAK21 2-PACK - CE...Stryker Corp.POL
Z-1904-2024Class IITrevo Pro 14 Microcatheter, Catalog: 90231; Trevo Pro 18 Microcatheter, Catalog: 90238Stryker Corp.DQO
Z-1903-2024Class IITrevo ProVue, Catalog: 90184Stryker Corp.NRY
Z-1902-2024Class IITrevo XP ProVue Retriever 4 x 20, Catalog: 90182 Trevo XP ProVue Retriever 3 x 20...Stryker Corp.POL
Z-1069-2025Class IImuRata Vios Monitoring System Model 2050; bedside cardiac monitor, including...Murata Vios, Inc.DRT
Z-2258-2024Class IIPrucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology recording...GE Medical Systems Information Technologies, Inc.DQK
Z-2034-2024Class IIStreptococcal A rapid test kits, labeled as: Wondfo Biotech Co., Ltd, WondView Strep A...Wondfo USA Co., Ltd.GTY
Z-2033-2024Class IIIndependent Medical Co-op Inc., Streptococcal A rapid test kits, labeled as: IMCO Strep...Wondfo USA Co., Ltd.GTY
Z-2032-2024Class IIStreptococcal A rapid test kits, labeled as: Easy Healthcare Corporation, Areta Strep A...Wondfo USA Co., Ltd.GTY
Z-2031-2024Class IIClarity and Clarity Diagnostics LLC, Streptococcal A rapid test kits, Labeled as: a)...Wondfo USA Co., Ltd.GTY
Z-1894-2024Class IICaptus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to...Mirion Technologies (Capintec), Inc.IZD
Z-1893-2024Class IICaptus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid...Mirion Technologies (Capintec), Inc.IZD
Z-1892-2024Class IICaptus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff...Mirion Technologies (Capintec), Inc.IZD
Z-1938-2024Class IIMedline Luer Slip Disposable Syringe without Needle, Ref Syr101020MEDLINE INDUSTRIES, LP - NorthfieldFMF
Z-1937-2024Class IIMedline Luer Lock Disposable Syringe without Needle, Ref Syr101010MEDLINE INDUSTRIES, LP - NorthfieldFMF
Z-1925-2024Class IIClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number...Alcon LaboratoriesHNN
Z-1924-2024Class IIClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number...Alcon LaboratoriesHNN
Z-1923-2024Class IIClearCut Sideport Knife Dual Bevel 1.2mm Angled Model/Catalog Number: 8065921541 Software...Alcon LaboratoriesHNN
Z-1922-2024Class II20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product...Alcon LaboratoriesHNN
Z-1830-2024Class IIIngenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical...Philips North America LLCLNH
Z-1829-2024Class IIIngenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical...Philips North America LLCLNH
Z-2030-2024Class IIPreview Strep A, Streptococcal A rapid test kits, Part Numbers: a) PRE-STA-25, b)...Wondfo USA Co., Ltd.GTY
Z-1827-2024Class IIPatient Information Center iX and Patient Information Center iX Expand, Software Version...Philips North America LLCMHX
Z-0025-2025Class IIBeckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic...Siemens Healthcare Diagnostics Inc.JJE
Z-2029-2024Class IIOES 4000 Hysteroscope, Model/Catalog Number: A4674AOLYMPUS Corporation of the AmericasHIH
Z-1941-2024Class IIThe Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are...Stryker Corp.DQX