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 166 of 1190
FDA device recalls, page 166 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0784-2024Class IIBeckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947Siemens Healthcare Diagnostics Inc.LKM
Z-1010-2024Class IIPulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045...Boston Scientific CorporationKRA
Z-0970-2024Class IIVortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25Vortex Surgical, Inc.HNR
Z-0814-2024Class IITactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an...Abbott MedicalOAE
Z-0620-2024Class Iregard Operative LAP, Item Number 800943001; surgical convenience kitROi CPS LLCLRO
Z-1167-2024Class IIEsg Pk Cutting Forceps, 5Mm, 33CmOLYMPUS Corporation of the AmericasGEI
Z-1007-2024Class IIExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No...Globus Medical, Inc.OLO
Z-1003-2024Class IITotal immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetrySiemens Healthcare Diagnostics Inc.CFN
Z-1073-2024Class IIProxiDiagnost upgrade- A Multi-functional general Radiography and Fluoroscopy (R/F)...Philips North America LLCJAA
Z-1072-2024Class IIProxiDiagnost N90- A Multi-functional general Radiography and Fluoroscopy (R/F)...Philips North America LLCJAA
Z-0931-2024Class IBrightView XCT, gamma camera for SPECT; Model Nos.: 6-digit format 882482; 12-digit...Philips North America LLCKPS
Z-0930-2024Class IBrightView X, gamma camera for SPECT; Model Nos.: 6-digit format 882478; 12-digit...Philips North America LLCKPS
Z-0929-2024Class IBrightView, gamma camera system; Model Nos.: 6-digit format 882480; 12-digit format...Philips North America LLCKPS
Z-0782-2024Class IIPANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid...Hologic, Inc.OOI
Z-0994-2024Class IIFilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test...BioFire Diagnostics, LLCQBH
Z-0993-2024Class IIFilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only...BioFire Diagnostics, LLCQDS
Z-1055-2024Class IISpectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software...Philips North America LLCJAK
Z-1054-2024Class IISpectral CT on Rails: Software Version 5.1.0.X, model 728334.Philips North America LLCJAK
Z-0815-2024Class IIDiaSorin LIAISON HSV-2 Type Specific IgG, REF 310620Diasorin Inc.MYF
Z-0781-2024Class IISedecal X Optima URS digital mobile diagnostic x-ray system. A a stationary x-ray unit...Sedecal S.A.KPR
Z-0710-2024Class IProduct REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery UnitMaquet Cardiovascular LLCCAC
Z-0709-2024Class IProduct REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single CollectionMaquet Cardiovascular LLCCAC
Z-0835-2024Class IIPhilips Azurion system, Interventional fluoroscopic x-ray system. System Product Name...Philips Medical Systems Nederland B.V.OWB
Z-0984-2024Class IIDual Articulating Headrest, Velcro P/N P141210813, REF BF753STERIS CorporationHBM
Z-0983-2024Class IIDual Articulating Headrest, Pad Ret P/N P141210805, REF BF754STERIS CorporationHBM
Z-0637-2024Class IHigh Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123Percussionaire Corp.CBK
Z-0733-2024Class IIVACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey...Greiner Bio-One North America, Inc.JKA
Z-0735-2024Class IITECNIS Toric II OptiBlue IOL Models ZCWAdvanced Medical Optics, Inc.MJP
Z-2737-2024Class IIBrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and...Ronan Medical LLCHCC
Z-1004-2024Class IIOlympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle...OLYMPUS Corporation of the AmericasETD
Z-0997-2024Class IIGlobus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement...Globus Medical, Inc.HAW
Z-0996-2024Class IIGlobus Medical Cranial Drill with Stop, 3.20mm - instruments for access, preparation...Globus Medical, Inc.HAW
Z-0995-2024Class IIGlobus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and...Globus Medical, Inc.HAW
Z-0991-2024Class IIFlow-e Anesthesia System, model 6887900Maquet Cardiovascular Us Sales, LLCBSZ
Z-0990-2024Class IIFlow-c Anesthesia System, model 6887700Maquet Cardiovascular Us Sales, LLCBSZ
Z-0989-2024Class IIFlow-i C40 Anesthesia System, model 6677400Maquet Cardiovascular Us Sales, LLCBSZ
Z-0988-2024Class IIFlow-i C30 Anesthesia System, model 6677300Maquet Cardiovascular Us Sales, LLCBSZ
Z-0987-2024Class IIFlow-i C20 Anesthesia System, model 6677200Maquet Cardiovascular Us Sales, LLCBSZ
Z-0834-2024Class IIENDOPATH ECHELON 45mm RELOADS WITH GRIPPING SURFACE TECHNOLOGY (GST), ECHELON Endopath...Ethicon Endo-Surgery IncGDW
Z-1942-2024Class IIWAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software...WAVi Co.GWQ
Z-0861-2024Class IIAzurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software...Philips Medical Systems Nederland B.V.OWB
Z-1071-2024Class IISingle Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope...OLYMPUS Corporation of the AmericasFDT
Z-0860-2024Class IIAzurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software...Philips Medical Systems Nederland B.V.OWB
Z-0707-2024Class IIXScribe CP Cardiac Stress Testing System, version 6, with below product names and...Baxter Healthcare CorporationDPS
Z-0600-2024Class IProduct Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode...Megadyne Medical Products, IncGEI
Z-0599-2024Class IProduct Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable...Megadyne Medical Products, IncGEI
Z-0598-2024Class IProduct Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable...Megadyne Medical Products, IncGEI
Z-0597-2024Class IProduct Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable...Megadyne Medical Products, IncGEI
Z-0706-2024Class IIXScribe Cardiac Stress Testing System, version 6, with below product names and...Baxter Healthcare CorporationDPS
Z-0705-2024Class IIQ-Stress Cardiac Stress Testing System, version 6, with below product name / product...Baxter Healthcare CorporationDPS