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Medical device recalls reported in 2019

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ReportedRecallClassProductFirm
2019-10-16Z-0041-2020Class IIGiraffe OmnibedOhmeda Medical
2019-10-16Z-0042-2020Class IIOnline TDM Vancomycin GenRoche Diagnostics Operations, Inc.
2019-10-16Z-0043-2020Class IIOnline TDM Vancomycin GenRoche Diagnostics Operations, Inc.
2019-10-16Z-0044-2020Class IIAssayTip/AssayCup Tray-used on the cobas e 801 module which is a part…Roche Diagnostics Operations, Inc.
2019-10-16Z-0045-2020Class IISPIFE ImmunoFix-6 KitHelena Laboratories, Corp.
2019-10-16Z-0046-2020Class IIAperio CS2 CE IVD scanner instrumentLeica Biosystems Imaging, Inc.
2019-10-16Z-0047-2020Class IISTRATAFIX Spiral PDS Plus Violet 18Ethicon, Inc.
2019-10-16Z-0048-2020Class IISTRATAFIX Spiral PDS Plus Violet 27Ethicon, Inc.
2019-10-16Z-0049-2020Class IICareFusion MaxPlus Clear Needleless ConnectorBecton Dickinson & Company
2019-10-16Z-0050-2020Class IIIEXACTAMED Oral DispensersBaxter Healthcare Corporation
2019-10-16Z-0051-2020Class II20" 2-Needle 26-Gauge 6mm HlgH-Flo Subcutaneous Safety Needle Sets"…Repro-Med Systems, Inc.
2019-10-16Z-0052-2020Class IIK2M Special Connector InstrumentsK2M, Inc
2019-10-16Z-0053-2020Class IIPediatric Two-Lumen Central Venous Catheterization Kit with Blue…Arrow International Inc
2019-10-16Z-0054-2020Class IIBD Microtainer ZBecton Dickinson & Company
2019-10-16Z-0055-2020Class IIBD Microtainer Tubes with LHBecton Dickinson & Company
2019-10-16Z-0056-2020Class IIBD Microtainer SST Part/Catalog NoBecton Dickinson & Company
2019-10-16Z-0057-2020Class IIBD MicrotainerTubes with K2EBecton Dickinson & Company
2019-10-16Z-0058-2020Class IIBD Microtainer SST- Amber Part/Catalog Number: 365978Becton Dickinson & Company
2019-10-16Z-0059-2020Class IIBD Microtainer PSTTubes with LHBecton Dickinson & Company
2019-10-16Z-0060-2020Class IIBD Microtainer PST Tubewith LHBecton Dickinson & Company
2019-10-16Z-0061-2020Class IIBD Microtainer Tubes with FEBecton Dickinson & Company
2019-10-16Z-0062-2020Class IIAIR Technology Anterior ArrayGE Healthcare, LLC
2019-10-16Z-0063-2020Class IIiTotal Hip Replacement SystemConformis, Inc.
2019-10-16Z-0064-2020Class IIiTotal Hip Replacement SystemConformis, Inc.
2019-10-16Z-0065-2020Class IIStryker NeurovascularStryker Neurovascular
2019-10-16Z-0066-2020Class IIBD FACSLyric Flow CytometerBecton, Dickinson and Company, BD Biosciences
2019-10-16Z-0067-2020Class IIBD FACSLyric Flow CytometerBecton, Dickinson and Company, BD Biosciences
2019-10-16Z-0068-2020Class IIBD FACSLyric Flow CytometerBecton, Dickinson and Company, BD Biosciences
2019-10-16Z-0069-2020Class IIBD FACSLyric Flow CytometerBecton, Dickinson and Company, BD Biosciences
2019-10-16Z-0070-2020Class IIBD FACSLyric Flow CytometerBecton, Dickinson and Company, BD Biosciences
2019-10-16Z-0071-2020Class IIBD FACSLyric Flow CytometerBecton, Dickinson and Company, BD Biosciences
2019-10-16Z-0072-2020Class IIBD FACSLyric Flow CytometerBecton, Dickinson and Company, BD Biosciences
2019-10-16Z-0073-2020Class IIBD FACSLyric Flow CytometerBecton, Dickinson and Company, BD Biosciences
2019-10-16Z-0074-2020Class IIBD FACSLyric Flow CytometerBecton, Dickinson and Company, BD Biosciences
2019-10-16Z-0075-2020Class IIPICC Line Accessory Kit CVI4285Centurion Medical Products Corporation
2019-10-16Z-0076-2020Class IIPEDIATRIC PICC INSERTION TRAY CVI4450Centurion Medical Products Corporation
2019-10-16Z-0077-2020Class IIPEDIATRIC PICC INSERTION TRAY CVI4450ACenturion Medical Products Corporation
2019-10-16Z-0078-2020Class IINEONATAL PROCEDURE TRAY PICC CATHETERS CVI4535Centurion Medical Products Corporation
2019-10-16Z-0079-2020Class IICVC BUNDLE WITHOUT CATH CVI4600Centurion Medical Products Corporation
2019-10-16Z-0080-2020Class IIPORT AND IO ACCESS DRESSING KIT DT15780ACenturion Medical Products Corporation
2019-10-16Z-0081-2020Class IICap Change Kit DT20310Centurion Medical Products Corporation
2019-10-16Z-0082-2020Class IINeonatal Cap Change Kit DT20315Centurion Medical Products Corporation
2019-10-16Z-0083-2020Class IICAP CHANGE KIT DYNDC1496BCenturion Medical Products Corporation
2019-10-16Z-0084-2020Class IIINFUSA PORT KIT DYNDC1840ECenturion Medical Products Corporation
2019-10-16Z-0085-2020Class IIINFUSA PORT KIT DYNDC1840FCenturion Medical Products Corporation
2019-10-16Z-0086-2020Class IISTERILE CAP CHANGE KIT DYNDC1946BCenturion Medical Products Corporation
2019-10-16Z-0087-2020Class IICAP BUNDLE KIT DYNDC2137Centurion Medical Products Corporation
2019-10-16Z-0088-2020Class IITRIPLE LUMEN BUNDLE KIT ECVC1540Centurion Medical Products Corporation
2019-10-16Z-0089-2020Class IICENTRAL VENOUS ACCESS DEVICE BUNDLE ECVC2840Centurion Medical Products Corporation
2019-10-16Z-0090-2020Class IICVC BUNDLECenturion Medical Products Corporation
2019-10-16Z-0091-2020Class IICVC BUNDLECenturion Medical Products Corporation
2019-10-16Z-0092-2020Class IICVC BUNDLECenturion Medical Products Corporation
2019-10-16Z-0093-2020Class IICVC BUNDLE MULTIMEDCenturion Medical Products Corporation
2019-10-16Z-0094-2020Class IICVC BUNDLE VANTEX 7FCenturion Medical Products Corporation
2019-10-16Z-0095-2020Class IICVC TRIPLE LUMEN SAFETY BUNDLE ECVC6070Centurion Medical Products Corporation
2019-10-16Z-0096-2020Class IICVC INSERTION BUNDLE 8Centurion Medical Products Corporation
2019-10-16Z-0097-2020Class IICENTRAL LINE BUNDLE ECVC6375Centurion Medical Products Corporation
2019-10-16Z-0098-2020Class IICENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545Centurion Medical Products Corporation
2019-10-16Z-0099-2020Class IICENTRAL LINE BUNDLE 16CM MULTIMED ECVC6545ACenturion Medical Products Corporation
2019-10-16Z-0100-2020Class IIOR VANTEX 7FR 3L 16CM CVC ECVC6665Centurion Medical Products Corporation
2019-10-16Z-0101-2020Class IIVANTEX 7FRCenturion Medical Products Corporation
2019-10-16Z-0102-2020Class IIIV START KIT IV8440Centurion Medical Products Corporation
2019-10-16Z-0103-2020Class IIIV SECUREMENT KIT IVS3405Centurion Medical Products Corporation
2019-10-16Z-0104-2020Class IIIV KITCenturion Medical Products Corporation
2019-10-16Z-0105-2020Class IIINVASIVE PROCEDURE TRAY MNS9510Centurion Medical Products Corporation
2019-10-16Z-0106-2020Class IITRIPLE LUMEN CVC 20CM BUNDLE STCVC2040Centurion Medical Products Corporation
2019-10-16Z-0107-2020Class IIUVC TRAY UVT875Centurion Medical Products Corporation
2019-10-16Z-0108-2020Class IIcobas c 311Roche Diagnostics Operations, Inc.
2019-10-16Z-0109-2020Class IIcobas c 701 and 702 Analyzer/Module-RF interference claims for the…Roche Diagnostics Operations, Inc.
2019-10-16Z-0110-2020Class IIYUKON Polyaxial ScrewsK2M, Inc
2019-10-16Z-0112-2020Class IIAchilles Insight Bone SonometerGE Healthcare, LLC
2019-10-16Z-0113-2020Class IIAchilles Express Bone SonometerGE Healthcare, LLC
2019-10-16Z-0118-2020Class IITriMed Dorsal Wrist Hook PlateTriMed Inc.
2019-10-16Z-0119-2020Class IIClinical ChemistryHoriba Instruments Incorporated
2019-10-16Z-0120-2020Class IICenturion CIRCLAMP W/1Centurion Medical Products Corporation
2019-10-16Z-0121-2020Class IICenturion CIRCLAMP W/1Centurion Medical Products Corporation
2019-10-09Z-0001-2020Class IISECURE EVAThe Metrix Company
2019-10-09Z-0002-2020Class IISECURE EVAThe Metrix Company
2019-10-09Z-0003-2020Class IISECURE EVAThe Metrix Company
2019-10-09Z-0004-2020Class IISECURE EVAThe Metrix Company
2019-10-09Z-0005-2020Class IISECURE EVAThe Metrix Company
2019-10-09Z-0006-2020Class IISECURE EVAThe Metrix Company
2019-10-09Z-0007-2020Class IIExactaMixThe Metrix Company
2019-10-09Z-0008-2020Class IIExactaMixThe Metrix Company
2019-10-09Z-0010-2020Class IIImplantDirect simply RePlant ImplantImplant Direct Sybron Manufacturing, LLC
2019-10-09Z-0011-2020Class IIVista Dental Products CanalClean Endodontic Irrigation KitInter-Med Llc
2019-10-09Z-0012-2020Class IIVista Dental Products Sodium HypochloriteInter-Med Llc
2019-10-09Z-0013-2020Class IIVista Dental Products Sodium HypochloriteInter-Med Llc
2019-10-09Z-0014-2020Class IIVista Dental Products Sodium HypochloriteInter-Med Llc
2019-10-09Z-0015-2020Class IIVista Dental Products 3% Sodium HypochloriteInter-Med Llc
2019-10-09Z-0016-2020Class IIVista Dental Products Chlor-XTRAInter-Med Llc
2019-10-09Z-0017-2020Class IIVista Dental Products Chlor-XTRAInter-Med Llc
2019-10-09Z-0018-2020Class IIImplantDirect Legacy 3 ImplantImplant Direct Sybron Manufacturing, LLC
2019-10-09Z-0019-2020Class IIPaltop Advanced Plus Dental Implant Dia 6Paltop Advanced Dental Solutions Ltd
2019-10-09Z-0023-2020Class IIC2 Nerve MonitorStryker Instruments Div. of Stryker Corporation
2019-10-09Z-0024-2020Class IIC2 Nerve MonitorStryker Instruments Div. of Stryker Corporation
2019-10-09Z-0026-2020Class IICustom Procedure KitMerit Medical Systems, Inc.
2019-10-09Z-0027-2020Class IICustom Procedure KitMerit Medical Systems, Inc.
2019-10-09Z-0028-2020Class IIGrandio SO Heavy Flow CapsVoco GmbH
2019-10-09Z-0029-2020Class IIIEmbryology Heated Plate within the RI WitnessCooperSurgical, Inc.
2019-10-09Z-0030-2020Class IIL5C4531 X1 Integrated APD Set with Cassette 3-Prong SterileBaxter Healthcare Corporation
2019-10-09Z-0031-2020Class IITxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model #…Quality Electrodynamics LLC
2019-10-09Z-0032-2020Class IITxRx 15CH Knee Coil 1Quality Electrodynamics LLC
2019-10-09Z-0033-2020Class IITxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model #…Quality Electrodynamics LLC
2019-10-09Z-0034-2020Class IITxRx 15CH Knee Coil 1Quality Electrodynamics LLC
2019-10-09Z-0035-2020Class IITxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model #…Quality Electrodynamics LLC
2019-10-09Z-0036-2020Class IITxRx Knee 15 Coil 1Quality Electrodynamics LLC
2019-10-09Z-0037-2020Class IITxRx Knee 15 Coil 1Quality Electrodynamics LLC
2019-10-09Z-2562-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2563-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2564-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2565-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2566-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2567-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2568-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2569-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2570-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2571-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2572-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2573-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2574-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2575-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2576-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2577-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2578-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2579-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2580-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2581-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2582-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2583-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2584-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2585-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2586-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2587-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2588-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2589-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2590-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2591-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2592-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2593-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2594-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2595-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2596-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2597-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2598-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2599-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2600-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2601-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2602-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2603-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2604-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2605-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2606-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2607-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2608-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2609-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2610-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2611-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2612-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2613-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2614-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2615-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2616-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2617-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2618-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2619-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2620-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2621-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2622-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2623-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2624-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2625-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2626-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2627-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2628-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2629-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2630-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2631-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2632-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2633-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2634-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2635-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2636-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2637-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2638-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2639-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2640-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2641-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2642-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2643-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2644-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2645-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2646-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2647-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2648-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2649-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2650-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2651-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2652-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular
2019-10-09Z-2653-2019Class ISHERPA NX ACTIVE GUIDING CATHETERMedtronic Vascular

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