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 47 of 1190
FDA device recalls, page 47 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1049-2026Class IIMedline Kits containing B. Braun IV Administration Sets and Pump Administration Sets...MEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-1026-2026Class IIBeckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288...Siemens Healthcare Diagnostics Inc.JJE
Z-1025-2026Class IIBeckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay...Siemens Healthcare Diagnostics Inc.JJE
Z-0995-2026Class IIRsch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The...Cook IncorporatedDYB
Z-0994-2026Class IIRing Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-100; 2)...Cook IncorporatedDYB
Z-0993-2026Class IIFlexor Check-Flo Introducers and Sets, Reference Part Numbers: 1)...Cook IncorporatedDYB
Z-1027-2026Class IIPhilips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R...Remote Diagnostic Technologies Ltd.MHX
Z-1005-2026Class IIBrand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number...Ferndale Laboratories, Inc.KGX
Z-1023-2026Class IFreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle...Abbott MedicalQLG
Z-1022-2026Class IFreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle...Abbott MedicalQLG
Z-0939-2026Class IBrand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers...Alcon LaboratoriesLRO
Z-0957-2026Class IIBIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.Smith & Nephew, Inc.HWC
Z-1021-2026Class IFreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle...Abbott MedicalQLG
Z-1020-2026Class IFreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3...Abbott MedicalQLG
Z-0925-2026Class IIZimmer Dermatome AN, Model/Catalog Number: 88710100Zimmer Surgical SAGFD
Z-0924-2026Class IIZimmer Air Dermatome, Model/Catalog Number: 00880100100Zimmer Surgical SAGFD
Z-0966-2026Class IILifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite...Abbott MedicalPHC
Z-0934-2026Class IDraeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.Draeger, Inc.CAD
Z-0933-2026Class IDraeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.Draeger, Inc.CAD
Z-0965-2026Class IILifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite...Abbott MedicalPHC
Z-1267-2026Class IIVivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration TestChangchun Wancheng Bio-Electron Co., Ltd.JJW
Z-1266-2026Class IIVivoo Vaginal pH TestChangchun Wancheng Bio-Electron Co., Ltd.LNW
Z-1265-2026Class IIVivoo Protein TestChangchun Wancheng Bio-Electron Co., Ltd.JIR
Z-1264-2026Class IIVivoo pH TestChangchun Wancheng Bio-Electron Co., Ltd.CEN
Z-1263-2026Class IIExploro Highly Sensitive Male Fertility / Sperm Concentration TestChangchun Wancheng Bio-Electron Co., Ltd.DFQ
Z-1262-2026Class IIMale Fertility Sperm Test for Home Use (Cassette)Changchun Wancheng Bio-Electron Co., Ltd.NRF
Z-1261-2026Class IIS. Typhi/Para Typhi A AntigenChangchun Wancheng Bio-Electron Co., Ltd.GPN
Z-1260-2026Class IIMenopause Test Cassette (Urine)Changchun Wancheng Bio-Electron Co., Ltd.NGA
Z-1259-2026Class IILH One Step Ovulation Test Device (Urine)Changchun Wancheng Bio-Electron Co., Ltd.NGE
Z-1258-2026Class IIThe Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis...Changchun Wancheng Bio-Electron Co., Ltd.JIN
Z-1257-2026Class IILotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER...Changchun Wancheng Bio-Electron Co., Ltd.LJX
Z-1035-2026Class IIMedline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO...MEDLINE INDUSTRIES, LP - NorthfieldBYG
Z-1048-2026Class IIIvenix Infusion System (IIS), LVP Software: LVP-SW-0005.Fresenius Kabi USA, LLCFRN
Z-1009-2026Class IIThe Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with...Roche Diagnostics GmbHJZO
Z-0996-2026Class IIRestore Clinician Programmer Application (CP App), Model A71100 used with the following...Medtronic NeuromodulationLGW
Z-0962-2026Class IIBD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliary, REF: 324...CareFusion 303, IncBRY
Z-1004-2026Class IIVortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;Vortex Surgical, Inc.HQB
Z-0910-2026Class IIAMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The...STERIS CorporationMEC
Z-0909-2026Class IIAMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The...STERIS CorporationMEC
Z-0923-2026Class IIBrand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common...AGFA Healthcare Corp.IZF
Z-0938-2026Class IIIHemosIL SynthAFax. Partial Thromboplastin Time Tests.Instrumentation Laboratory Co.GFO
Z-0941-2026Class IIIntelerad InteleShare software, with ProViewer componentDICOM Grid (dba Ambra Health)LLZ
Z-0920-2026Class IIHardware configuration of the BeneVision Central Monitoring System (CMS), marketed as...Datascope Corp.MSX
Z-1428-2026Class IIDa Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally...Intuitive Surgical, Inc.NAY
Z-1311-2026Class IIBrand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile...Etac A/SFSA
Z-1310-2026Class IIBrand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile...Etac A/SFSA
Z-1309-2026Class IIBrand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2)...Etac A/SFSA
Z-1308-2026Class IIBrand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2)...Etac A/SFSA
Z-1029-2026Class IIThe Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure MonitorSophysaGWM
Z-1006-2026Class IISheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tapered to 2.9"W x 11.8"L (2.2cm...Sheathing Technologies IncITX