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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

59,336 records, page 12 of 1187
FDA device recalls, page 12 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2779-2026Class IIMedline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2765-2026Class IMEDLINE medical procedure convenience kit labeled as: 1) TOTAL KNEE-LF, Medline kit SKU...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-2764-2026Class IMEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2699-2026Class IIKL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,Klowen Braces dba Klowen OrthodonticsQJJ
Z-2887-2026Class IIHardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g (FDC30)...Hardy DiagnosticsJTN
Z-2648-2026Class IIARTIS icono ceiling. Model Number: 11328100.Siemens Medical Solutions USA, Inc.OWB
Z-2703-2026Class IIAtellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.Siemens Healthcare Diagnostics Inc.PDJ
Z-2677-2026Class IIAquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile RConvaTec LimitedFRO
Z-2749-2026Class IMEDLINE convenience kits labeled as: 1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-2748-2026Class IMEDLINE convenience kits labeled as: 1) C-SECTION, Medline SKU DYNJ910835; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOHM
Z-2747-2026Class IMEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640GMEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2728-2026Class IIOptima XR240amx, Mobile Digital Radiographic SystemGE HealthcareIZL
Z-2727-2026Class IIOptima XR220amx, Mobile Digital-Ready Radiographic SystemGE HealthcareIZL
Z-2726-2026Class IIOptima XR200amx, Mobile Digital-Ready Radiographic SystemGE HealthcareIZL
Z-2714-2026Class IIOmniTract Surgical Retractor System, which includes 633 of the firm s product codes.Integra LifeSciences CorporationGAD
Z-2579-2026Class IIPhilips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following...Philips North America LLCMHX
Z-2676-2026Class IIOlympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III...OLYMPUS Corporation of the AmericasFDT
Z-2645-2026Class IIBrand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog...Medela AGFPA
Z-2916-2026Class IIBrand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number...GE HealthcareMHX
Z-2715-2026Class IIVITEK 2 AST-N447 TEST KIT Product reference 424620bioMerieux, Inc.LON
Z-2654-2026Class IIMEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number...BD Switzerland SARLFPA
Z-2770-2026Class IIPenumbra System RED 68 Reperfusion Catheter REF: RED68KITPenumbra Inc.NRY
Z-2623-2026Class IIGC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460Remel IncJTY
Z-2741-2026Class IIThe Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000...Maquet Cardiovascular LLCGEI
Z-2649-2026Class IIZeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557Carl Zeiss Meditec IncJAD
Z-2709-2026Class IBone Marrow Tray, REF: CB0033TL; CB0355TLAArgon Medical Devices, IncKNW
Z-2708-2026Class IArterial Line Kit 20ga x 6, REF: 400115AArgon Medical Devices, IncGDY
Z-2707-2026Class IT-Lok Bone Marrow Tray, REF: BMT1104STL; BMET1104TL; BMT1104CATLArgon Medical Devices, IncKNW
Z-2706-2026Class IGeneral Biospy Tray, REF: GUTS1000Argon Medical Devices, IncKNW
Z-2705-2026Class IOne-Piece Introducer Tray, REF: 497455, 497434 cardiovascularArgon Medical Devices, IncDRE
Z-2704-2026Class ITransvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F, REF: 008416A...Argon Medical Devices, IncOEZ
Z-2777-2026Class IIEmano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a...Emano Metrics, Inc.EXY
Z-2463-2026Class IBreathing circuit set, coaxial: REF: 260127, 260128, 260167, 260168 used with...Hamilton Medical AGBZO
Z-2762-2026Class IISeaSpine Polyaxial Head REF Number: 41-3010SeaSpine Orthopedics CorporationNKB
Z-2613-2026Class IIMedline Convenience kits containing recalled Swan-Ganz Catheters CABG A...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-2612-2026Class IIMedline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-2611-2026Class IIMedline Convenience kits containing recalled Swan-Ganz Catheters OPEN...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2610-2026Class IIMedline Convenience kits containing recalled Swan-Ganz Catheters CV ANESTHESIA - ROOM...MEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-2609-2026Class IIMedline Convenience kits containing recalled Swan-Ganz Catheters KIT GERMANTOWN...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2608-2026Class IIMedline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-2607-2026Class IIMedline Convenience kits containing recalled Swan-Ganz Catheters CARDIAC...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-2606-2026Class IIMedline Convenience kits containing recalled Swan-Ganz Catheters RIGHT HEART CATH PACK...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-2697-2026Class IIMedline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2) OPEN...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2696-2026Class IIMedline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-2695-2026Class IIMedline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP10125AMEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-2532-2026Class IIAcumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe...Acumed LLCHRS
Z-2698-2026Class IIMiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896Medtronic, Inc.QFG
Z-2400-2026Class IIAdvance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28Inter-Med, Inc.MVL
Z-2574-2026Class IIBrand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US...Dexcom, Inc.QBJ
Z-2523-2026Class IIPhilips Avalon Fetal Monitor, FM 30 Part numberM2703APhilips North America LLCHGM