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 82 of 1190
FDA device recalls, page 82 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2099-2025Class IIBrand Name: Canturio Smart Extension Product Name: CSE Implant Model/Catalog Number...Canary Medical USA LLCQPP
Z-1910-2025Class IIChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)Healthmark Industries Co., Inc.MNL
Z-1909-2025Class IIPre-filled Water Syringe, Model Numbers SW-010-100 and SW-010Healthmark Industries Co., Inc.MNL
Z-1937-2025Class IIBD BBL CultureSwab EZ Collection and Transport System, REF 220144, in vitro Diagnostic...Copan ItaliaJTW
Z-1875-2025Class IICatalog No. 8888160648; Umbilical Vessel Catheter 5 French triple lumenMedtronic, Inc.FOS
Z-1874-2025Class IICatalog No. 8888160556; Umbilical Vessel Catheter 5 French dual lumenMedtronic, Inc.FOS
Z-1873-2025Class IICatalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumenMedtronic, Inc.FOS
Z-1872-2025Class IICatalog No. 8888160333; Umbilical Vessel Catheter 3.5 French single lumenMedtronic, Inc.FOS
Z-1871-2025Class IICatalog No. 8888160325; Umbilical Vessel Catheter 2.5 French single lumenMedtronic, Inc.FOS
Z-1870-2025Class IICatalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French...Medtronic, Inc.FOS
Z-1763-2025Class IILifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1...Abbott MedicalPHC
Z-2172-2025Class IIThe Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store...Implant Direct Sybron Manufacturing LLCKCT
Z-1892-2025Class IIBX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter)...CIVCO Medical Instruments Co., Inc.ITX
Z-1947-2025Class IIThermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/...Remel IncJWY
Z-1863-2025Class IIGM Helix Acqua Implant, Article Number: 140.985Straumann USA, LLCDZE
Z-1862-2025Class IIGM Helix Acqua Implant, Article Number: 140.984Straumann USA, LLCDZE
Z-1814-2025Class IAdult Manual Resuscitator with Medium Adult Mask, Bag REservoir, Filter, Manometer and 7...Salter LabsBTM
Z-1877-2025Class IIBioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systemsBioFire Diagnostics, LLCOCC
Z-1823-2025Class IICardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the...MAQUET CARDIOPULMONARY GmbHDTQ
Z-1908-2025Class IISample probe sucks a sample dispensed into a tube or cup and discharges the appropriate...Beckman Coulter Mishima K.K.JJE
Z-1907-2025Class IISample probe sucks a sample dispensed into a tube or cup and discharges the appropriate...Beckman Coulter Mishima K.K.CKB
Z-1992-2025Class II5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following...Fresenius Medical Care Renal Therapies Group, LLCKDI
Z-1924-2025Class IIAzure S DR MRI SureScan, Product number W3DR01Medtronic, Inc.NVZ
Z-2110-2025Class IIBrand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many...Alcon LaboratoriesLRO
Z-2109-2025Class IIBrand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined...Alcon LaboratoriesHQC
Z-2108-2025Class IIBrand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy...Alcon LaboratoriesMLZ
Z-1749-2025Class IIAlinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse...Abbott Molecular, Inc.QJR
Z-1748-2025Class IIAlinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex...Abbott Molecular, Inc.QJR
Z-1864-2025Class IINxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403...NxStage Medical IncKPO
Z-1976-2025Class IIIAcoSound. Model Number: LW12-BTE-MHangzhou Acosound Technology Co., Ltd.QUG
Z-1955-2025Class IIBrand Name: Tecfen Medical Product Name: 3.2mm Slit Knife, Angled Model/Catalog Number...Tecfen MedicalHNN
Z-1954-2025Class IIBrand Name: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled Bevel...Tecfen MedicalHNN
Z-1953-2025Class IIBrand Name: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport Knife...Tecfen MedicalHNN
Z-1952-2025Class IIBrand Name: Tecfen Medical Product Name: 2.8mm Slit Knife, Angled Model/Catalog Number...Tecfen MedicalHNN
Z-1951-2025Class IIBrand Name: Tecfen Medical Product Name: 2.4mm Slit Knife, Angled Model/Catalog Number...Tecfen MedicalHNN
Z-1950-2025Class IIBrand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number...Tecfen MedicalHNN
Z-1949-2025Class IIBrand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number...Tecfen MedicalHNN
Z-1938-2025Class IIMUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large capacity...GE Medical Systems Information Technologies, Inc.DSI
Z-1965-2025Class IIiBOT PMD with software version 01.05.24. Personal Mobility Device.Mobius Mobility LLCIMK
Z-1855-2025Class IIHemocue Inc Gluc Aqueous 1Hi/lo Hemcue Control Kit.Mckesson Medical-Surgical Inc. Corporate OfficeJJX
Z-1854-2025Class IISekisui Diagnostics Llc Serum Hcg Osomgenzme Control Set.Mckesson Medical-Surgical Inc. Corporate OfficeJJX
Z-1853-2025Class IIAbbott Diagnostics Alinity I Anti-Ccps Reagent.Mckesson Medical-Surgical Inc. Corporate OfficeNHX
Z-1852-2025Class IIAbbott Diagnostics Alinity I Free Psa Us(200test/ea) Reagent.Mckesson Medical-Surgical Inc. Corporate OfficeMTG
Z-1851-2025Class IIAbbott Diagnostics Architect Progesterone (100Tests) Reagent.Mckesson Medical-Surgical Inc. Corporate OfficeJIT
Z-1850-2025Class IIAbbott Diagnostics Architect Free T4abbdia Calibrator.Mckesson Medical-Surgical Inc. Corporate OfficeJIT
Z-1849-2025Class IIAbbott Diagnostics Architect Total T36x4ml Calibrator.Mckesson Medical-Surgical Inc. Corporate OfficeJIT
Z-1848-2025Class IIAbbott Diagnostics Architect Vitamind 6Level Calibrator.Mckesson Medical-Surgical Inc. Corporate OfficeJIT
Z-1847-2025Class IIAbbott Diagnostics Architect Hbsag Assay(100tst/bx) Bds Reagent.Mckesson Medical-Surgical Inc. Corporate OfficeLOM
Z-1846-2025Class IIAbbott Point of Care Test Crea I-Stat (25/Bx) Abbtpt Cartridge.Mckesson Medical-Surgical Inc. Corporate OfficeCGL
Z-1845-2025Class IIAbbott Diagnostics Architect HIV Combo 1X4ml Calibrator.Mckesson Medical-Surgical Inc. Corporate OfficeMZF