510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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

59,486 records, page 336 of 1190
FDA device recalls, page 336 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1236-2022Class II1.8mm Truss Wire, REF: 900217, a Component of Metalogix Revolution External Plating SystemFusion Orthopedics USA, LLCKTT
Z-2695-2020Class IIAccurian RF Ablation,Cannula pk, Accurian, 100mm, 22G, 10mm, SS Product Number: AC0019...Medtronic Sofamor Danek USA IncGXI
Z-2694-2020Class IIAccurian RF Ablation, Cannula pk, Accurian, 100mm, 22G, 5mm, CS Product Number: AC0016...Medtronic Sofamor Danek USA IncGXI
Z-2693-2020Class IIAccurian RF Ablation, Cannula pk, Accurian, 150mm, 20G, 10mm, CS Product Number: AC0012...Medtronic Sofamor Danek USA IncGXI
Z-2692-2020Class IIAccurian RF Ablation, Cannula pk, Accurian, 100mm, 20G, 10mm, CS Product Number: AC0009...Medtronic Sofamor Danek USA IncGXI
Z-2691-2020Class IIAccurian RF Ablation, Cannula pk, Accurian, 150mm, 18G, 10mm, CS Product Number: AC0007...Medtronic Sofamor Danek USA IncGXI
Z-2690-2020Class IIAccurian RF Ablation, Cannula pk, Accurian, 100mm, 18G, 10mm, CS Product Number: AC0005...Medtronic Sofamor Danek USA IncGEX
Z-2418-2020Class IILokomat Pro, Catalog Numbers 30003 LokomatPro L6.2 120V AD ; 30004 LokomatPro L6.2 120V...Hocoma AGIKK
Z-2531-2020Class IIPhilips M3015A Microstream CO2 Extension Model No. 862393 -used with an lntelliVue X3...Philips North America LLCDSI
Z-2542-2020Class IIACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI...KCI USA, Inc.OMP
Z-2707-2020Class IIStealthStation" S7 System with Polaris Spectra Camera part number PSU 9733437 - Product...Medtronic Navigation, IncHAW
Z-2779-2020Class IISTAT KIT Z-1000 emergency medical kit HealthFirst - Product Usage: is intended to prepare...HF Acquisition Co. LLCLRR
Z-2706-2020Class IITube Set for TEM - Product Usage: Transanal Endoscopic Microsurgery (TEM) combination...Richard Wolf GmbHHIF
Z-2431-2020Class IIAtellica CH Chemistry CalibratorSiemens Healthcare Diagnostics Inc.CGX
Z-2430-2020Class IIADVIA Chemistry CalibratorSiemens Healthcare Diagnostics Inc.NDW
Z-2539-2020Class IIOrthoPediatrics ACL Reconstruction System ShieldLoc 7mm implant component model number...Orthopediatrics CorpMBI
Z-2538-2020Class IIOrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component model number...Orthopediatrics CorpMBI
Z-2476-2020Class IGlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope...Verathon Inc.CCW
Z-2791-2020Class IISTAT KIT Model 550AI Emergency Medical Kit. P/N: 1010830 containing various products to...HF Acquisition Co. LLCLRR
Z-2790-2020Class IISTAT KIT Model 550 Emergency Medical Kit P/N: 1009580 containing various products to...HF Acquisition Co. LLCLRR
Z-2789-2020Class IISTAT KIT, Model SM30 ; Emergency Medical Kit P/N: 1008670 containing various products to...HF Acquisition Co. LLCLRR
Z-2788-2020Class IIHealthFirst Emergency Medical Kit, Model SM 7, P/N: 1008150; Manufactured by HF...HF Acquisition Co. LLCLRR
Z-2683-2020Class IIAblation Galil Technology, IceForce 2.1 CX 90 Cyroablation Needles, Prescription...Boston Scientific CorporationGEH
Z-2682-2020Class IIAblation Galil Technology, IcePearl 2.1 CX 90 Cyroablation Needles, Prescription...Boston Scientific CorporationGEH
Z-2681-2020Class IIAblation Galil Technology, Three IceFORCE 2.1 Prostate Cyroablation Kit Visual ICE...Boston Scientific CorporationGEH
Z-2680-2020Class IIAblation Galil Technology, Three IceFORCE 2.1 CX Prostate Cyroablation Kit Visual ICE...Boston Scientific CorporationGEH
Z-2679-2020Class IIAblation Galil Technology, IcePearl2.1 CX ProstateKit Visual Ice System, Prescription...Boston Scientific CorporationGEH
Z-2678-2020Class IIAblation Galil Technology, IceFORCE 2.1 CX Prostate Kit Visual ICE System, Prescription...Boston Scientific CorporationGEH
Z-2677-2020Class IIAblation Galil Technology, IceFORCE 2.1 CX Needle Cryoablation Needle, Prescription...Boston Scientific CorporationGEH
Z-2676-2020Class IIAblation Galil Technology, IcePearl 2.1 CX Needle Cryoablation Needle, Prescription...Boston Scientific CorporationGEH
Z-2675-2020Class IIAblation Galil Technology, IceFORCE 2.1 CX 90 Needle Cryoablation Needle, Prescription...Boston Scientific CorporationGEH
Z-2544-2020Class IICardinal Health NPWT Occlusion Detection Canister 300cc, Prescription Only - Product...Medtronic, Inc.OMP
Z-2543-2020Class IICardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The...Medtronic, Inc.OMP
Z-2513-2020Class IISolara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06Medtronic, Inc.NVZ
Z-2512-2020Class IISerena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05Medtronic, Inc.NVZ
Z-2511-2020Class IIPercepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04Medtronic, Inc.NVZ
Z-2510-2020Class IIAzure S SR MRI, Model Number W3SR01Medtronic, Inc.NVZ
Z-2509-2020Class IIAzure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01Medtronic, Inc.NVZ
Z-2508-2020Class IIAzure S DR MRI, Model Number W3DR01Medtronic, Inc.NVZ
Z-2507-2020Class IIAzure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01Medtronic, Inc.NVZ
Z-2506-2020Class IIPatient Connector, Model Number 24967Medtronic, Inc.NVZ
Z-2505-2020Class IICareLink SmartSync Device Manager, Model Number 24970AMedtronic, Inc.NWD
Z-2674-2020Class IIAblation Galil Technology, IcePearl 2.0 CX 90 Cryoablation Needle, Prescription...Boston Scientific CorporationGEH
Z-2952-2020Class IIPrimeStore Molecular Transport Medium (PS-MTM), Model Numbers LH-1-2, LH-1-3, LH-1-4...Longhorn Vaccines and Diagnostics LLCQBD
Z-2534-2020Class IIDUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle...Dufner Instrumente GmbHFHQ
Z-2551-2020Class IIMagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001...Roche Molecular Systems IncJJH
Z-2422-2020Class IIHYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are...Coltene /Whaledent AGEJG
Z-2421-2020Class IIHYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are...Coltene /Whaledent AGEJG
Z-2420-2020Class IIHYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are...Coltene /Whaledent AGEJG
Z-2419-2020Class IIHYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are...Coltene /Whaledent AGEJG