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 83 of 1190
FDA device recalls, page 83 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1844-2025Class IIAbbott Diagnostics Arc T-Uptake Assay (100Tst/bx) Abbdia Reagent.Mckesson Medical-Surgical Inc. Corporate OfficeJZO
Z-1843-2025Class IIAbbott Diagnostics Arc Anti-Tpo Assay 100Tst B Reagent.Mckesson Medical-Surgical Inc. Corporate OfficeJZO
Z-1842-2025Class IIAbbott Diagnostics Arch Ausab Anti-Hbs (100/Ea) Reagent.Mckesson Medical-Surgical Inc. Corporate OfficeLOM
Z-1841-2025Class IIAbbott Diagnostics Probe Conditioning F/architect Anlyz Abbdia Solution.Mckesson Medical-Surgical Inc. Corporate OfficeJJE
Z-1840-2025Class IIAbbott Diagnostics Arc Carbon Dioxide6x5ml B Calibrator.Mckesson Medical-Surgical Inc. Corporate OfficeJIX
Z-1839-2025Class IIHemocue Inc Hemotrol High 2X1ml Level 3 Hemcue Control.Mckesson Medical-Surgical Inc. Corporate OfficeJJY
Z-1838-2025Class IIHemocue Inc Hemotrol Low 2X1ml Level 1 Hemcue Control.Mckesson Medical-Surgical Inc. Corporate OfficeJJY
Z-1837-2025Class IIOrtho Clinical Diagnostics Inc Vitros Bun (60/Cr 5Cr/pk) Orclnl Reagent.Mckesson Medical-Surgical Inc. Corporate OfficeCDN
Z-1836-2025Class IIOrtho Clinical Diagnostics Inc Anti-B Bioclone 10Ml3x10ml.Mckesson Medical-Surgical Inc. Corporate OfficeQHR
Z-1835-2025Class IIOrtho Clinical Diagnostics Inc Total Bili-Alkp Xt (L-Sequester) (300/Pk) Reagent.Mckesson Medical-Surgical Inc. Corporate OfficeCJE
Z-1834-2025Class IIOrtho Clinical Diagnostics Inc Fs(3pk/bx)orclnl Diluent Pack 3.Mckesson Medical-Surgical Inc. Corporate OfficePPM
Z-1833-2025Class IIOrtho Clinical Diagnostics Inc Vancomycin (300/Bx)orclnl Reagent.Mckesson Medical-Surgical Inc. Corporate OfficeLEH
Z-1832-2025Class IIOrtho Clinical Diagnostics Inc Vitros Phosphorus (60/Cr 5Cr/pk) Orclnl Reagent.Mckesson Medical-Surgical Inc. Corporate OfficeCEO
Z-1831-2025Class IIOrtho Clinical Diagnostics Inc Vitros Calcium (L-Sequester) (300/Pk) Reagent.Mckesson Medical-Surgical Inc. Corporate OfficeCJY
Z-1830-2025Class IIAbbott Rapid Dx N America Llc Hba1c Hemoglobin Afinion Glyctd (15Tst/bx) Test Kit.Mckesson Medical-Surgical Inc. Corporate OfficeLCP
Z-1829-2025Class IIBd Microbiology Mac Conkey II Agar (100/Ct) 21270 Media.Mckesson Medical-Surgical Inc. Corporate OfficeJSI
Z-1828-2025Class IIBd Microbiology Fluid Thioglycollate Med Tube 1004321196 (100/Ct) Media.Mckesson Medical-Surgical Inc. Corporate OfficeJSG
Z-1827-2025Class IIHemocue Inc F/glucose 201 Analyzer (25/Vl 4Vl/bx) Microcuvette.Mckesson Medical-Surgical Inc. Corporate OfficeCGA
Z-1826-2025Class IIAbbott Rapid Dx N America Llc Cholestech Ldx Lipid Profile+glucose (10/Bx 50Bx/cs) Test.Mckesson Medical-Surgical Inc. Corporate OfficeJGY
Z-1825-2025Class IIAbbott Rapid Dx N America Llc, Test Cholestec Ldxlipid Profile (10/Bx 50Bx/cs) Cassettes.Mckesson Medical-Surgical Inc. Corporate OfficeJGY
Z-1824-2025Class IIAbbott Rapid Dx N America Llc Multi Analyte Lvl1&2250ul Chols ControlMckesson Medical-Surgical Inc. Corporate OfficeJJY
Z-1767-2025Class IBaxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUSBaxter Healthcare CorporationFRN
Z-1905-2025Class IIMIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system...Virtual Incision CorporationSAB
Z-1889-2025Class IIMAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.Mozarc Medical US LLCMSD
Z-1888-2025Class IIPalindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane...Mozarc Medical US LLCMSD
Z-1887-2025Class IIPalindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane...Mozarc Medical US LLCMSD
Z-1886-2025Class IIPalindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane...Mozarc Medical US LLCMSD
Z-1885-2025Class IIPalindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane...Mozarc Medical US LLCMSD
Z-1913-2025Class IIDxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20Siemens Healthcare Diagnostics Inc.JLW
Z-1926-2025Class IIDxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions...Siemens Healthcare Diagnostics Inc.JLW
Z-1815-2025Class IIIApo B Reagent, REF: OSR6143Beckman Coulter Ireland IncJHN
Z-2231-2025Class II3M Ranger Irrigation Fluid Warming Set, REF 247503M CompanyLGZ
Z-1811-2025Class IMedline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-1810-2025Class IMedline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349CMEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-1809-2025Class IMedline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1858-2025Class IIBrand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst...C-Rad Positioning ABIYE
Z-1991-2025Class IIICU Medical Plum Solos, Item number 400011001; infusion pumpAbbott MedicalFRN
Z-1990-2025Class IIICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003...Abbott MedicalFRN
Z-1746-2025Class IEndopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product...Ethicon Endo-Surgery IncGDW
Z-2198-2025Class IIPrecision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide...Capnia IncCCJ
Z-1916-2025Class IILOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK...American Contract Systems, Inc.OJH
Z-1754-2025Class IIBIB Balloon in Balloon Dilatation Catheter. Model Number: 420Numed IncNVM
Z-1808-2025Class IIBD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD...Becton Dickinson Infusion Therapy Systems Inc.FOZ
Z-1671-2025Class IIWB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.Straumann USA, LLCNHA
Z-1787-2025Class IICheck=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF...Cook IncorporatedDYB
Z-1786-2025Class IICheck=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF...Cook IncorporatedDYB
Z-1762-2025Class IITornado Embolization Microcoil, intended for embolization of selective vessel supply to...Cook IncorporatedKRD
Z-1759-2025Class IBard Single Intragastric Linton Balloon Tube, REF: 0092740C.R. Bard IncKNT
Z-1758-2025Class IBard Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300C.R. Bard IncKNT
Z-1757-2025Class IBard Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110C.R. Bard IncKNT