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 158 of 1190
FDA device recalls, page 158 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1223-2026Class IIBrand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use...OLYMPUS Corporation of the AmericasKNS
Z-1222-2026Class IIBrand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use...OLYMPUS Corporation of the AmericasKNS
Z-3298-2024Class IIOrigio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of...CooperSurgical, Inc.MQL
Z-3297-2024Class IIOrigio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of...CooperSurgical, Inc.MQL
Z-3296-2024Class IIOrigio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of...CooperSurgical, Inc.MQL
Z-1317-2024Class IIAbre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b)...Medtronic, Inc.QAN
Z-1381-2024Class IIMedivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802CMedivance Inc.DWJ
Z-1290-2024Class IICARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM...Biosense Webster IncDYB
Z-1172-2025Class IIAugustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model A138...Augustine Temperature Management, LLCDWJ
Z-1171-2025Class IIAugustine Surgical Inc. HotDog Return Electrode accessory connector cables, Model...Augustine Temperature Management, LLCDWJ
Z-3312-2024Class IIDIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system...Philips North America LLCMHX
Z-1539-2024Class IIMasimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only,Masimo CorporationDQA
Z-1538-2024Class IIMasimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only,Masimo CorporationDQA
Z-1537-2024Class IIMasimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only,Masimo CorporationDQA
Z-1536-2024Class IIMasimo Rad-G, Pulse Oximeter with temperature (W/Sensor), REF:9210, Rx Only,Masimo CorporationDQA
Z-1605-2024Class IIMariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF...SeaSpine Orthopedics CorporationNKB
Z-1358-2024Class IIBio-Rad, REF: 12005660, QXDx BCR-ABL %IS KitBio-Rad Laboratories Inc.OYX
Z-1458-2024Class IICovidien Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVTMedtronic, Inc.GDW
Z-1457-2024Class IISignia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVTMedtronic, Inc.GDW
Z-1369-2024Class IICystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox...Randox Laboratories, LimitedNDY
Z-1289-2024Class IISTERIS Boot Assembly, Traction Device, OT 1000, Part Number REF 10009192Baxter Healthcare CorporationFWZ
Z-1141-2024Class IIHeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM...HeartSine Technologies LtdMKJ
Z-1382-2024Class IGeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b)...DeRoyal Industries, Inc.LRO
Z-1308-2024Class IICuraplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal intubation to...Sarnova HC, LLCLNZ
Z-1307-2024Class IICuraplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intubation to...Sarnova HC, LLCLNZ
Z-1318-2024Class IIAssembly, Array Guide TMINI, REF: 109101, part of the TMINI Knee Instrument Set, used...Think Surgical Inc.OLO
Z-1302-2024Class IBoston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050Boston Scientific CorporationDRA
Z-1267-2024Class IARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a)...Arrow International LLC (subsidiary of Teleflex Incorporated)DQX
Z-1321-2024Class IIPreat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967PREAT CorporationNHA
Z-2586-2024Class IIBrand Name: UNclog Eye Mask Product Name: UNclog Eye Mask Model/Catalog Number: AG23JW24...Eye Comfort Care LLCIRT
Z-1506-2024Class IIChromophare Surgical Light System , REF CH00000001STRYKER Communications, Inc.FSY
Z-1349-2024Class IImicroStar Reader, Model Numbers: 10015-000 (marketed in EMEA as 100, 102, 110, and 201)...LandauerLHO
Z-1303-2024Class IIAccess Total T4, REF 33800, IVD, thyroxine reagent assay.Siemens Healthcare Diagnostics Inc.KLI
Z-1181-2024Class IISoftware VERIQA (S070031), version 2.0 and 2.1- Software package for display, evaluation...PTW-FreiburgIYE
Z-1291-2024Class IICLEARLINK Non-DEHP Solution Set Luer Lock Adapter, Product Code 2R8401Baxter Healthcare CorporationFPA
Z-1376-2024Class IIAccess Substrate, REF 81906, For use with the Access Immunoassay SystemsSiemens Healthcare Diagnostics Inc.PPM
Z-1426-2024Class IITorrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX...Life Technologies CorporationPFF
Z-1275-2024Class Ismiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUSAbbott MedicalBTL
Z-1274-2024Class Ismiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUSAbbott MedicalBTL
Z-1316-2024Class IIMedtronic DLP Vessel Cannula, Model Number REF 30000Medtronic Perfusion SystemsDWF
Z-1304-2024Class IIDCA Systems HbA1c Reagent KitSiemens Healthcare Diagnostics Inc.LCP
Z-1306-2024Class IInatus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series...Medtronic, Inc.GYB
Z-1305-2024Class IITENSIVE Conductive Adhesive Gel, REF 016-401600Medtronic, Inc.GYB
Z-1299-2024Class IISPII Model Lubinus, Long Stem Prosthesis XL Neck, cementedWaldemar Link GmbH & Co. KGJDG
Z-1298-2024Class IISPII Model Lubinus, Long Stem Prosthesis Standard Neck, cementedWaldemar Link GmbH & Co. KGJDG
Z-1297-2024Class IISPII Model Lubinus, Hip Prosthesis Stem XL Neck, cementedWaldemar Link GmbH & Co. KGJDG
Z-1296-2024Class IISPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cementedWaldemar Link GmbH & Co. KGJDG
Z-1266-2024Class IINo 4 Triathlon Ts Plus Tib Ins X3 Poly 16 MmHowmedica Osteonics CorpMBH
Z-1265-2024Class IINo 4 Triathlon Ts Plus Tib Ins X3 Poly 16 MmHowmedica Osteonics CorpMBH
Z-1264-2024Class IINo 4 Triathlon Ts Plus Tib Ins X3 Poly 11 MmHowmedica Osteonics CorpMBH