510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK 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

59,544 records, page 598 of 1191
FDA device recalls, page 598 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1179-2016Class IIAlaris Pump VersaSafe Infusion Set, Model No. 2122-0007CareFusion 303, IncFPA
Z-2918-2018Class IIImmunoscan CCPlus test kit is an enzyme-linked immunosorbent assay (ELISA) for...Svar Life Science ABNHX
Z-0877-2017Class IIBD SurePathTM Preservative Collection Vials, catalog numbers 490505, 490527, 491095...Becton Dickinson & CoMKQ
Z-1253-2016Class II10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number...Highridge Medical, LLCOVD
Z-1190-2016Class IIInstinct Java System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral...Zimmer Spine, Inc.NKB
Z-1189-2016Class IIUniversal Clamp System (IFU reference: SNA027-N-90001). Provides the stability required...Zimmer Spine, Inc.NKB
Z-1239-2016Class IIAlaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092CareFusion 303, IncFRO
Z-1026-2016Class IIHelioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal...Ivoclar Vivadent, Inc.EBC
Z-0888-2016Class IIMammomat Inspiration with Tomosynthesis functionalitySiemens Medical Solutions USA, Inc.OTE
Z-1269-2016Class IIMicroScan LabPro Information Manager System, Software Versions 1.0 to 4.41 Catalog No...Siemens Healthcare Diagnostics Inc.OUG
Z-1235-2016Class IIKAMRA Inlay, ACI 7000 Corneal Inlay, Part No. 76195-01 and 76195-10 (OUS) Labeling: The...AcuFocus, Inc.LQE
Z-1046-2016Class IIM/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093Zimmer GmbHLPH
Z-1172-2016Class IIAccu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose...Roche Diagnostics GmbHLFR
Z-1362-2016Class IIUSE (Ebony) PTA .014" rapid exchange (RX) Peripheral Dilatation Catheter. Distributed by...Us EndovascularLIT
Z-1274-2016Class ISimplexa Group A Strep Direct (MOL2850) with Direct Amplification Disc (MOL1451, MOL1452...DiaSorin Molecular LLCPGX
Z-1273-2016Class ISimplexa Flu A/B & RSV Direct (MOL2650) with Direct Amplification Disc (MOL1451, MOL1452...DiaSorin Molecular LLCOCC
Z-1712-2016Class IIRayStation Therapy Treatment Planning System Stand-alone Software 3.0, 3.5, 4.0, 4.5 and...RaySearch Laboratories AB (publ)MUJ
Z-1272-2016Class ISimplexa HSV 1&2 Direct (MOL2150) with Direct Amplification Disc (MOL1451, MOL1452...DiaSorin Molecular LLCPGH
Z-1098-2016Class IIIntra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T...IMRIS Imaging, Inc.LNH
Z-1236-2016Class IIAmbu, Aura Gain - Single Use Laryngeal Mask- Sterile for use as an alternative to a face...Ambu Inc.BTO
Z-1053-2016Class IILightSpeed QX/I (4-slice MDAS) LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT...GE HealthcareJAK
Z-1052-2016Class IILightSpeed Plus (4-slice MDAS LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT...GE HealthcareKPS
Z-1051-2016Class IILightSpeed 16 (MDAS only , , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed...GE HealthcareKPS
Z-1050-2016Class IIDiscovery ST, , 2339985 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner...GE HealthcareKPS
Z-1049-2016Class IIDiscovery LS, 2286327 LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner...GE HealthcareKPS
Z-1317-2016Class IIeValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A disposable heel...Philips North America LLCIMD
Z-1316-2016Class IIevaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer...Philips North America LLCIMD
Z-1063-2016Class IPercutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow IAB is utilized for intra...Arrow International LLC (subsidiary of Teleflex Incorporated)DSP
Z-1062-2016Class IPercutaneous Insertion Tray; Product Code: IAK-06845 The Arrow IAB is utilized for intra...Arrow International LLC (subsidiary of Teleflex Incorporated)DSP
Z-1061-2016Class IRediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow IAB is utilized for intra...Arrow International LLC (subsidiary of Teleflex Incorporated)DSP
Z-1060-2016Class IUltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow IAB is utilized for intra...Arrow International LLC (subsidiary of Teleflex Incorporated)DSP
Z-1059-2016Class IUltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow IAB is utilized for intra...Arrow International LLC (subsidiary of Teleflex Incorporated)DSP
Z-1058-2016Class IUltra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow IAB is utilized for intra...Arrow International LLC (subsidiary of Teleflex Incorporated)DSP
Z-1057-2016Class IFiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow IAB is utilized...Arrow International LLC (subsidiary of Teleflex Incorporated)DSP
Z-1056-2016Class IUltra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow IAB is utilized for intra...Arrow International LLC (subsidiary of Teleflex Incorporated)DSP
Z-1055-2016Class IFiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow IAB is utilized for intra aortic balloon...Arrow International LLC (subsidiary of Teleflex Incorporated)DSP
Z-1048-2016Class IILightSpeed Ultra (8-slice MDAS), 5120327-3 LightSpeed 4.0 CT Scanner System - The...GE HealthcareJAK
Z-2709-2016Class IIMerge Cardio software. The firm name on the label is Merge Healthcare, Hartland, WI...Merge Healthcare IncorporatedLLZ
Z-1633-2016Class IIDimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN...Siemens Healthcare Diagnostics Inc.NRP
Z-1271-2016Class IIMedtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.Medtronic NeuromodulationLKK
Z-1069-2016Class IIDenali Filter-Femoral Delivery System Product Code: DL900F/DL950F; Indicated for use in...Bard Peripheral Vascular IncDTK
Z-1068-2016Class IIDenali Filter-Jugular/Subclavian Delivery System Product Code: DL900J/DL950J; Indicated...Bard Peripheral Vascular IncDTK
Z-1328-2016Class IIMicroAire PAL Cannula Product Usage - Power Aspiration DeviceMicroAire Surgical Instruments, LLCGEA
Z-1083-2016Class IITF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended to fill a...Ormco/SybronendoEKM
Z-1323-2016Class IIMicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannulaMicroAire Surgical Instruments, LLCBTA
Z-2363-2016Class IIMerge PACS software. The firm name on the label is Merge Healthcare, Inc., Hartland...Merge Healthcare IncorporatedLLZ
Z-2274-2016Class IIAllegra X-5 rotor yoke, Catalog No. (Instruments) B30589 and B30590 (Rotor) B30593...Siemens Healthcare Diagnostics Inc.JQC
Z-1356-2016Class IIIngenuity CT Computed Tomography X-ray Systems, Intended to produce cross-sectional...Philips North America LLCJAK
Z-1355-2016Class IIIngenuity Core 128 Computed Tomography X-ray Systems, Intended to produce...Philips North America LLCJAK
Z-1354-2016Class IIIngenuity Core Computed Tomography X-ray Systems, Intended to produce cross-sectional...Philips North America LLCJAK