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 170 of 1190
FDA device recalls, page 170 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0816-2024Class IICustom procedural convenience kits and trays, anesthesia, labeled as: a) HEART...American Contract Systems, Inc.OFQ
Z-0683-2024Class IISensis Vibe HemoSiemens Medical Solutions USA, Inc.DQK
Z-0711-2024Class IIMedline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS...MEDLINE INDUSTRIES, LP - NorthfieldFYA
Z-0549-2024Class IIvenix Infusion System (IIS), Large Volume Pump LVP-0004Fresenius Kabi USA, LLCFRN
Z-0665-2025Class IIMICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, #...Micro-X Ltd.IZL
Z-0701-2024Class IIVADER pedicle system, torque wrench, Catalog Number 42-703Icotec AGPML
Z-0932-2024Class IIVolar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S...Trimed IncHRS
Z-0846-2024Class IICortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5...Xtant Medical Holdings, Inc.NKB
Z-0928-2024Class IIPackaged, Tank Hose Assembly CMA-US, Product Catalog Number A001056AtriCure, Inc.GEH
Z-0927-2024Class IICryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053AtriCure, Inc.GEH
Z-0732-2024Class II(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436Philips North America LLCMHX
Z-0731-2024Class II(1) Patient Information Center iX, Model No. 866389 (2) Patient Information Center iX...Philips North America LLCMHX
Z-0675-2024Class IIMYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial...Cordis US Corp.MGB
Z-0674-2024Class IIMYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and...Cordis US Corp.MGB
Z-0699-2024Class IIMedtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUSMedtronic Navigation, IncOLO
Z-0698-2024Class IIMedtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUSMedtronic Navigation, IncOLO
Z-0700-2024Class IIVADER pedicle system, torque wrench, Catalog Number 42-702Icotec AGPML
Z-0713-2024Class IIScoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a...MO-Vis BVKNN
Z-0635-2024Class IIEDS 3 CSF External Drainage System, REF: NT821731C, STERILEEO, Rx onlyNatus Medical IncorporatedJXG
Z-0634-2024Class IIExternal Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx onlyNatus Medical IncorporatedJXG
Z-1069-2024Class IICaptus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine...Mirion Technologies (Capintec), Inc.IZD
Z-0772-2024Class IIVITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No...Ortho-Clinical Diagnostics, Inc.LOM
Z-0638-2024Class IITrilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13...Respironics, Inc.CBK
Z-0704-2024Class IIThe BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test...BioFire Diagnostics, LLCQOF
Z-0703-2024Class IIBIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic...BioFire Diagnostics, LLCPCH
Z-0618-2024Class IIRibLoc U Plus 90 Instrument PRIMARY GUIDE ASSY, LOW PROFILE REF RBL2320 The RBL2320, Low...Acumed LLCLXH
Z-3158-2024Class IIThe device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI...FUJIFILM Healthcare Americas CorporationIZL
Z-1592-2024Class IIActim PROM dipstik, REF 30831ETUS; qualitative immunoassay rapid test for rupture of...Actim OyOAM
Z-0622-2024Class IIDeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572DeRoyal Industries, Inc.LRO
Z-0982-2024Class IIDxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,Siemens Healthcare Diagnostics Inc.JJE
Z-0981-2024Class IIAccess Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer...Siemens Healthcare Diagnostics Inc.CFP
Z-0712-2024Class IIQMS Tacrolimus Calibrators, Product code 10015573Ortho-Clinical Diagnostics, Inc.JIT
Z-0588-2024Class IIExactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23...Exactech, Inc.NTG
Z-0587-2024Class IIExactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03Exactech, Inc.HSN
Z-0586-2024Class IIExactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029...Exactech, Inc.JWH
Z-0585-2024Class IIExactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509...Exactech, Inc.JWH
Z-0584-2024Class IIExactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009Exactech, Inc.JWH
Z-0583-2024Class IIExactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b)...Exactech, Inc.JWH
Z-0582-2024Class IIExactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29...Exactech, Inc.JWH
Z-0581-2024Class IIExactech Novation Hip System, Catalog Numbers: 134-36-45Exactech, Inc.KWZ
Z-0580-2024Class IIExactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03...Exactech, Inc.KWS
Z-0579-2024Class IIExactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00...Exactech, Inc.KWT
Z-0578-2024Class IIExactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640...Exactech, Inc.LPH
Z-0577-2024Class IIAcuMatch Hip System, Catalog Number 142-32-27Exactech, Inc.OQI
Z-0972-2024Class IINovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code...Thor Photomedicine Inc.ILY
Z-0753-2024Class IICalibration Serum Level 3 - IVD For use as a Calibrator in clinical chemistry...Randox Laboratories, LimitedJIX
Z-0752-2024Class IICalibration Serum Level 3 CAL2351Randox Laboratories, LimitedJIX
Z-0645-2024Class IIOLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-10 Used...OLYMPUS Corporation of the AmericasHET
Z-0644-2024Class IIOLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used...OLYMPUS Corporation of the AmericasHET
Z-0623-2024Class IIProtege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80...Medtronic, Inc.NIP