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Medical device recalls reported in 2023

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ReportedRecallClassProductFirm
2023-12-27Z-0511-2024Class I0Nurse Assist, LLC
2023-12-27Z-0512-2024Class I0Nurse Assist, LLC
2023-12-27Z-0513-2024Class ISterile Water/Saline: Brand Name: Product Name/Product Code:…Nurse Assist, LLC
2023-12-27Z-0514-2024Class ISterile Water/Saline: Product Name/Product Code: CUP STERILE WATER¿…Nurse Assist, LLC
2023-12-27Z-0515-2024Class ISterile Water: Product Name/Product Code: USP STERILE WATER…Nurse Assist, LLC
2023-12-27Z-0536-2024Class IAirFit N10 Nasal Masks and User GuideResMed Ltd.
2023-12-27Z-0537-2024Class IAirFit F20 Full Face Mask and User GuideResMed Ltd.
2023-12-27Z-0538-2024Class IAirTouch F20 Full Face Mask and User GuideResMed Ltd.
2023-12-27Z-0539-2024Class IAirFit N20 Nasal Mask and User GuideResMed Ltd.
2023-12-27Z-0540-2024Class IAirTouch N20 Nasal Mask and User GuideResMed Ltd.
2023-12-27Z-0541-2024Class IAirFit F30 Full Face Mask and User GuideResMed Ltd.
2023-12-27Z-0542-2024Class IAirFit F30i Full Face Mask and User GuideResMed Ltd.
2023-12-27Z-0549-2024Class IIvenix Infusion SystemFresenius Kabi USA, LLC
2023-12-27Z-0558-2024Class IIPhilips Allura systems with monoplane fixed ceiling mounts: 722001…PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2023-12-27Z-0559-2024Class IIPhilips Azurion systems with monoplane fixed ceiling mounts: 722078…PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2023-12-27Z-0560-2024Class IIRoche Cobas 8000 and Cobas PRO Interface ModuleInpeco S.A.
2023-12-27Z-0564-2024Class IIVERO BIOTECH GENOSYL DSVero Biotech, LLC
2023-12-27Z-0565-2024Class IICardioQuip Modular Cooler-HeaterCardioQuip, LLC
2023-12-27Z-0566-2024Class IICardioQuip Modular Cooler-HeaterCardioQuip, LLC
2023-12-27Z-0567-2024Class IIAC Power Adapter for use with the LIFEPAK 15 Monitor/DefibrillatorPhysio-Control, Inc.
2023-12-27Z-0568-2024Class IIACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA…Olympus Corporation of the Americas
2023-12-27Z-0569-2024Class IIBiolox Ceramic Option Head Zimmer 12/14 40mm -3Biomet, Inc.
2023-12-27Z-0570-2024Class IIBiolox Ceramic Option Head Zimmer 12/14 40mm +0Biomet, Inc.
2023-12-27Z-0571-2024Class IIInjection NeedleKarl Storz Endoscopy
2023-12-27Z-0572-2024Class IIInjection NeedleKarl Storz Endoscopy
2023-12-27Z-0573-2024Class IIInjection NeedleKarl Storz Endoscopy
2023-12-27Z-0574-2024Class IIInjection NeedleKarl Storz Endoscopy
2023-12-27Z-0575-2024Class IIInjection NeedleKarl Storz Endoscopy
2023-12-27Z-0576-2024Class IIThe device is a whole-body CT x-ray systemPhilips North America Llc
2023-12-27Z-0577-2024Class IIAcuMatch Hip SystemExactech, Inc.
2023-12-27Z-0578-2024Class IIExactech Alteon Hip XLE LinerExactech, Inc.
2023-12-27Z-0579-2024Class IIExactech Equinoxe Reverse Shoulder SystemExactech, Inc.
2023-12-27Z-0580-2024Class IIExactech Equinoxe Shoulder SystemExactech, Inc.
2023-12-27Z-0581-2024Class IIExactech Novation Hip SystemExactech, Inc.
2023-12-27Z-0582-2024Class IIExactech Optetrak Knee SystemExactech, Inc.
2023-12-27Z-0583-2024Class IIExactech Optetrak Logic Knee SystemExactech, Inc.
2023-12-27Z-0584-2024Class IIExactech Optetrak Logic PS Knee SystemExactech, Inc.
2023-12-27Z-0585-2024Class IIExactech Truliant Knee SystemExactech, Inc.
2023-12-27Z-0586-2024Class IIExactech TruliantExactech, Inc.
2023-12-27Z-0587-2024Class IIExactech Vantage Ankle SystemExactech, Inc.
2023-12-27Z-0588-2024Class IIExactech Vantage Mobile Bearing Tibial InsertsExactech, Inc.
2023-12-27Z-0589-2024Class IIAcrobat-i Vacuum Positioner SystemMaquet Cardiovascular, LLC
2023-12-27Z-0595-2024Class IIICARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon…Maquet Medical Systems USA
2023-12-27Z-0601-2024Class IIepoc NXS Host Blood Analysis SystemSiemens Healthcare Diagnostics Inc
2023-12-27Z-0602-2024Class IIZEUS ELISA Parvovirus B19 IgG Test SystemZeus Scientific, Inc.
2023-12-27Z-0603-2024Class IIZEUS ELISA Parvovirus B19 IgM Test SystemZeus Scientific, Inc.
2023-12-27Z-0604-2024Class IIAbbott CELL-DYN RubyAbbott Laboratories
2023-12-27Z-0605-2024Class IIVenous probe connection cableMaquet Medical Systems USA
2023-12-27Z-0606-2024Class IIRAPIDPoint 500 Systems Measurement CartridgeSiemens Healthcare Diagnostics Inc
2023-12-27Z-0607-2024Class IIRAPIDPoint 500 Systems Measurement CartridgeSiemens Healthcare Diagnostics Inc
2023-12-27Z-0608-2024Class IIRAPIDPoint 500 Systems Measurement CartridgeSiemens Healthcare Diagnostics Inc
2023-12-27Z-0609-2024Class IIRAPIDPoint 500 Systems Measurement CartridgeSiemens Healthcare Diagnostics Inc
2023-12-27Z-0610-2024Class IILITe Decompression Snake ArmStryker Spine
2023-12-20Z-0505-2024Class IPanorama 1Philips North America Llc
2023-12-20Z-0509-2024Class IISpectranetics Turbo-Elite Laser Atherectomy Catheter 2Spectranetics Corporation
2023-12-20Z-0516-2024Class IIThe 4Kscore TestBioReference Health, LLC
2023-12-20Z-0517-2024Class IISagiPlan 2Bebig Isotopentechnik Gmbh
2023-12-20Z-0518-2024Class IIIconix Knotless 1Riverpoint Medical, LLC
2023-12-20Z-0519-2024Class IIPara-Pak Clean Vial-For the collectionMeridian Bioscience Inc
2023-12-20Z-0520-2024Class IIPara-Pak Zn-PVA/10% Formalin-for the routine collectionMeridian Bioscience Inc
2023-12-20Z-0521-2024Class IICardinal Health Clean Stool Transportation System-For the collectionMeridian Bioscience Inc
2023-12-20Z-0522-2024Class IIMedtronic SynchroMedMedtronic Inc.
2023-12-20Z-0523-2024Class IIARTIS iconoSiemens Medical Solutions USA, Inc
2023-12-20Z-0524-2024Class IIPHYSICA HPS Tibial Liner #6 H10 REF 6539Limacorporate S.p.A
2023-12-20Z-0525-2024Class IISTERILE PVP SOLUTIONMEDLINE INDUSTRIES, LP - Northfield
2023-12-20Z-0526-2024Class IISTERILE PVP SLN KITMEDLINE INDUSTRIES, LP - Northfield
2023-12-20Z-0527-2024Class IISTERILE STERILE PREP STICKMEDLINE INDUSTRIES, LP - Northfield
2023-12-20Z-0528-2024Class IISTERILE PVPMEDLINE INDUSTRIES, LP - Northfield
2023-12-20Z-0529-2024Class IIPVP SOLUTION SING STRLMEDLINE INDUSTRIES, LP - Northfield
2023-12-20Z-0530-2024Class IISTERILE BETADINEMEDLINE INDUSTRIES, LP - Northfield
2023-12-20Z-0531-2024Class IISTERILE POVIDONEMEDLINE INDUSTRIES, LP - Northfield
2023-12-20Z-0532-2024Class IIRSP Glenoid BaseplateEncore Medical, LP
2023-12-20Z-0533-2024Class IIMedline Leg bagMEDLINE INDUSTRIES, LP - Northfield
2023-12-20Z-0534-2024Class IIMedline Leg bagMEDLINE INDUSTRIES, LP - Northfield
2023-12-20Z-0535-2024Class IIMedline Leg bagMEDLINE INDUSTRIES, LP - Northfield
2023-12-20Z-0543-2024Class IIVITROS 3600 Immunodiagnostic System Product Code 6802783 and…Ortho-Clinical Diagnostics, Inc.
2023-12-20Z-0544-2024Class IIVITROS 4600 Chemistry System Product Code 6802445 and Refurbished…Ortho-Clinical Diagnostics, Inc.
2023-12-20Z-0545-2024Class IIVITROS 5600 Integrated System Product Code 6802413 and Refurbished…Ortho-Clinical Diagnostics, Inc.
2023-12-20Z-0546-2024Class IIVITROS XT 3400 Chemistry System Product Code 6844458 Running Software…Ortho-Clinical Diagnostics, Inc.
2023-12-20Z-0547-2024Class IIVITROS XT 7600 Integrated System Product Code 6844461 Running…Ortho-Clinical Diagnostics, Inc.
2023-12-20Z-0548-2024Class ICereLink ICP Extension CableIntegra LifeSciences Corp.
2023-12-20Z-0550-2024Class IIBaxter Amia Automated Peritoneal DialysisBaxter Healthcare Corporation
2023-12-20Z-0551-2024Class IIChange Healthcare Stratus Imaging PACS 1CHANGE HEALTHCARE CANADA COMPANY
2023-12-20Z-0552-2024Class IIThe System is designed as a modular system with components that…GE Hangwei Medical Systems, Co. LTD
2023-12-20Z-0553-2024Class IIThe System is designed as a modular system with components that…GE Hangwei Medical Systems, Co. LTD
2023-12-20Z-0554-2024Class IISensica Urine Output SystemC.R. Bard Inc
2023-12-20Z-0555-2024Class IICARDIOHELP-i Heart Lung Support System- A blood oxygenation and…Maquet Medical Systems USA
2023-12-20Z-0556-2024Class IIINavik 3D v2APN Health LLC
2023-12-20Z-0557-2024Class IITRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GPOlympus Corporation of the Americas
2023-12-13Z-0355-2024Class IInfusomat Administration Sets as listed below: 362031 Infusomat Space…B. Braun Medical, Inc.
2023-12-13Z-0420-2024Class ICARDIOHELP Emergency DriveMaquet Medical Systems USA
2023-12-13Z-0424-2024Class IIProCuity bed seriesStryker Medical Division of Stryker Corporation
2023-12-13Z-0425-2024Class IIProCuity bed seriesStryker Medical Division of Stryker Corporation
2023-12-13Z-0426-2024Class IIProCuity bed seriesStryker Medical Division of Stryker Corporation
2023-12-13Z-0427-2024Class IIProCuity bed seriesStryker Medical Division of Stryker Corporation
2023-12-13Z-0428-2024Class IIProCuity bed seriesStryker Medical Division of Stryker Corporation
2023-12-13Z-0429-2024Class IIProCuity bed seriesStryker Medical Division of Stryker Corporation
2023-12-13Z-0430-2024Class IIProCuity bed seriesStryker Medical Division of Stryker Corporation
2023-12-13Z-0431-2024Class IIProCuity bed seriesStryker Medical Division of Stryker Corporation
2023-12-13Z-0432-2024Class IIProCuity bed seriesStryker Medical Division of Stryker Corporation
2023-12-13Z-0433-2024Class IIProCuity bed seriesStryker Medical Division of Stryker Corporation
2023-12-13Z-0434-2024Class IIProCurity bed seriesStryker Medical Division of Stryker Corporation
2023-12-13Z-0435-2024Class IIProCurity bed seriesStryker Medical Division of Stryker Corporation
2023-12-13Z-0436-2024Class IIProCurity bed seriesStryker Medical Division of Stryker Corporation
2023-12-13Z-0437-2024Class IIDRX Revolution Mobile X-Ray SystemCarestream Health, Inc.
2023-12-13Z-0438-2024Class IICardioQuip Modular Cooler-HeaterCardioQuip, LLC
2023-12-13Z-0439-2024Class IICardioQuip Modular Cooler-HeaterCardioQuip, LLC
2023-12-13Z-0440-2024Class IIAutomated Impella ControllerAbiomed, Inc.
2023-12-13Z-0441-2024Class IIAutomated Impella ControllerAbiomed, Inc.
2023-12-13Z-0442-2024Class IIELEKTA LIMITED Precise Digital AcceleratorElekta, Inc.
2023-12-13Z-0443-2024Class IIELEKTA LIMITED Elekta SynergyElekta, Inc.
2023-12-13Z-0444-2024Class IIELEKTA LIMITED Elekta Synergy PlatformElekta, Inc.
2023-12-13Z-0445-2024Class IIELEKTA LIMITED Versa HDElekta, Inc.
2023-12-13Z-0446-2024Class IIELEKTA LIMITED Elekta InfinityElekta, Inc.
2023-12-13Z-0447-2024Class IIELEKTA AXESSEElekta, Inc.
2023-12-13Z-0448-2024Class IIMonarch Platform REF MON-000005-01AURIS HEALTH INC
2023-12-13Z-0449-2024Class IIMonarch Platform REF MON-000005-01RAURIS HEALTH INC
2023-12-13Z-0450-2024Class IIMonarch Platform REF MON-000006 100-240V- 50/60Hz 1440wAURIS HEALTH INC
2023-12-13Z-0451-2024Class IIBIOFIRE Blood Culture Identification 2BioFire Diagnostics, LLC
2023-12-13Z-0452-2024Class IIFreedom Boom models series: F110IHB OPERATIONS B.V.
2023-12-13Z-0453-2024Class IINovoTHOR Gen 2Thor Photomedicine Ltd
2023-12-13Z-0454-2024Class IIG041 PODThor Photomedicine Ltd
2023-12-13Z-0455-2024Class IINovoTHOR Gen 2Thor Photomedicine Ltd
2023-12-13Z-0456-2024Class IINovoTHOR Gen 2Thor Photomedicine Ltd
2023-12-13Z-0457-2024Class IIQUANTUM TTC BILIARY BALLOON DILATORWilson-Cook Medical Inc.
2023-12-13Z-0458-2024Class IIQUANTUM TTC BILIARY BALLOON DILATORWilson-Cook Medical Inc.
2023-12-13Z-0459-2024Class IIQUANTUM TTC BILIARY BALLOON DILATORWilson-Cook Medical Inc.
2023-12-13Z-0460-2024Class IIQUANTUM TTC BILIARY BALLOON DILATORWilson-Cook Medical Inc.
2023-12-13Z-0461-2024Class IIQUANTUM TTC BILIARY BALLOON DILATORWilson-Cook Medical Inc.
2023-12-13Z-0462-2024Class IIQUANTUM TTC BILIARY BALLOON DILATORWilson-Cook Medical Inc.
2023-12-13Z-0463-2024Class IIQUANTUM TTC BILIARY BALLOON DILATORWilson-Cook Medical Inc.
2023-12-13Z-0464-2024Class IIEVO+VISIAN Implantable Collamer LensStaar Surgical Company
2023-12-13Z-0465-2024Class IIEVO+VISIAN Implantable Collamer LensStaar Surgical Company
2023-12-13Z-0466-2024Class IIEVO+VISIAN Implantable Collamer LensStaar Surgical Company
2023-12-13Z-0467-2024Class IIEVO +VISIAN Implantable Collamer LensStaar Surgical Company
2023-12-13Z-0468-2024Class IIEVO VISIAN Implantable Collamer LensStaar Surgical Company
2023-12-13Z-0469-2024Class IIEVO VISIAN Implantable Collamer Lens REF: VICMO13Staar Surgical Company
2023-12-13Z-0470-2024Class IIEVO+VISIAN Implantable Collamer LensStaar Surgical Company
2023-12-13Z-0471-2024Class IIEVO+VISIAN Implantable Collamer LensStaar Surgical Company
2023-12-13Z-0472-2024Class IIEVO+VISIAN Implantable Collamer LensStaar Surgical Company
2023-12-13Z-0473-2024Class IIEVO+VISIAN Implantable Collamer LensStaar Surgical Company
2023-12-13Z-0474-2024Class IIEVO VISIAN Implantable Collamer LensStaar Surgical Company
2023-12-13Z-0475-2024Class IIHVADHeartware, Inc.
2023-12-13Z-0476-2024Class IISTERILE HVADHeartware, Inc.
2023-12-13Z-0477-2024Class IIHVADHeartware, Inc.
2023-12-13Z-0478-2024Class IIPUMP 1103 HVADHeartware, Inc.
2023-12-13Z-0479-2024Class IIPUMP 1104 HVADHeartware, Inc.
2023-12-13Z-0480-2024Class II1104CA-CLINHeartware, Inc.
2023-12-13Z-0481-2024Class IIPUMP 1104 HVADHeartware, Inc.
2023-12-13Z-0482-2024Class IIHVADHeartware, Inc.
2023-12-13Z-0483-2024Class IIPUMP MCS1705PU HVADHeartware, Inc.
2023-12-13Z-0484-2024Class IIAtrium Firm PVC Thoracic Catheter 36FR StraightAtrium Medical Corporation
2023-12-13Z-0485-2024Class IIAtrium Oasis Dry Suction Water Seal Chest DrainAtrium Medical Corporation
2023-12-13Z-0486-2024Class IIAtrium Oasis Dry Suction Water Seal Chest DrainAtrium Medical Corporation
2023-12-13Z-0487-2024Class IIRemington MEDICAL Drainage BagRemington Medical, Inc.
2023-12-13Z-0488-2024Class IIvyaire Flexible Patient CircuitVyaire Medical
2023-12-13Z-0489-2024Class IIvyaire Flexible Patient CircuitVyaire Medical
2023-12-13Z-0490-2024Class IISTAT-Site M BHB Test StripsStanbio Laboratory, LP
2023-12-13Z-0491-2024Class IIIntegra Cranial access kitIntegra LifeSciences Corp.
2023-12-13Z-0492-2024Class IIIntegra Cranial Access Kit -For access to the subarachnoid space or…Integra LifeSciences Corp.
2023-12-13Z-0493-2024Class IIIntegra Cranial Access KitIntegra LifeSciences Corp.
2023-12-13Z-0494-2024Class IIIntegra¿ Cranial Access Kit-For access to the subarachnoid space or…Integra LifeSciences Corp.
2023-12-13Z-0495-2024Class IIIntegra Cranial Access Kit-For access to the subarachnoid space or…Integra LifeSciences Corp.
2023-12-13Z-0496-2024Class IIIntegra Cranial Access Kit- For access to the subarachnoid space or…Integra LifeSciences Corp.
2023-12-13Z-0497-2024Class IIIntegra¿ Cranial Access Kit-For access to the subarachnoid space or…Integra LifeSciences Corp.
2023-12-13Z-0498-2024Class IIIntegra Cranial Access Kit-For access to the subarachnoid space or…Integra LifeSciences Corp.
2023-12-13Z-0499-2024Class IICombo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the…Integra LifeSciences Corp.
2023-12-13Z-0500-2024Class IILuminex VERIGENE BC-GP Utility TrayLuminex Corporation
2023-12-13Z-0501-2024Class IIRANDOX Total BilirubinRandox Laboratories Ltd.
2023-12-13Z-0502-2024Class IICooper Surgical H/S ELLIPTOSPHERE CATH 5 Fr -For administering…CooperSurgical, Inc.
2023-12-13Z-0503-2024Class IICooper Surgical H/S ELLIPTOSPHERE CATH 5 FR Set-For administering…CooperSurgical, Inc.
2023-12-13Z-0504-2024Class IICooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model:…CooperSurgical, Inc.
2023-12-13Z-0506-2024Class IIMulti-Mode StimulatorLiberty Medical Solutions, LLC
2023-12-13Z-0507-2024Class IIStay Safe CapFresenius Medical Care Holdings, Inc.
2023-12-13Z-0508-2024Class IIDJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated…Encore Medical, LP
2023-12-13Z-0510-2024Class IIVITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use onlyOrtho-Clinical Diagnostics, INc.
2023-12-06Z-0400-2024Class IIBD Insyte Autoguard BC Shielded IV Catheter with Blood Control…Becton Dickinson Infusion Therapy Systems Inc.
2023-12-06Z-0401-2024Class IISENTIEROPATH
2023-12-06Z-0402-2024Class IISENTIERO Screening2PATH
2023-12-06Z-0403-2024Class IIAuDX PROPATH
2023-12-06Z-0404-2024Class IISENTIERO SCREENINGPATH
2023-12-06Z-0405-2024Class IIwith Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc…Breas Medical, Inc.
2023-12-06Z-0406-2024Class IIDa Vinci Single-Site Wristed Needle DriverIntuitive Surgical, Inc.
2023-12-06Z-0407-2024Class IIAlinity m HCV AMP kitAbbott Molecular, Inc.
2023-12-06Z-0408-2024Class IILugol s Iodine Solution 500MLEMD Millipore Corporation
2023-12-06Z-0409-2024Class IIAcumen IQ SensorEdwards Lifesciences, LLC
2023-12-06Z-0410-2024Class IIAcumen IQ Sensor with VAMP SystemEdwards Lifesciences, LLC
2023-12-06Z-0411-2024Class IIFloTrac SensorEdwards Lifesciences, LLC
2023-12-06Z-0412-2024Class IIFloTrac Sensor with Vamp SystemEdwards Lifesciences, LLC
2023-12-06Z-0413-2024Class IITruWave Pressure monitoring setEdwards Lifesciences, LLC
2023-12-06Z-0414-2024Class IITruWave with Vamp System Pressure monitoring setEdwards Lifesciences, LLC
2023-12-06Z-0415-2024Class IICF-HQ190L EVIS EXERA III COLONOVIDEOSCOPEAizu Olympus Co., Ltd.
2023-12-06Z-0416-2024Class IIGIF-H190Aizu Olympus Co., Ltd.
2023-12-06Z-0417-2024Class IIGIF-HQ190Aizu Olympus Co., Ltd.
2023-12-06Z-0418-2024Class IIPCF-H190DLAizu Olympus Co., Ltd.
2023-12-06Z-0419-2024Class IIPCF-H190LAizu Olympus Co., Ltd.
2023-12-06Z-0421-2024Class IIICM LNQ22 LINQ IIMedtronic Inc.
2023-12-06Z-0422-2024Class IIRAPIDPOINT 500e Blood Gas SystemSiemens Healthcare Diagnostics Inc
2023-12-06Z-0423-2024Class IIRAPIDPOINT 500 Blood Gas SystemSiemens Healthcare Diagnostics Inc
2023-11-29Z-0232-2024Class IVariSoft infusion setUnomedical A/S

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