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Medical device recalls reported in 2023

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ReportedRecallClassProductFirm
2023-11-29Z-0233-2024Class IVariSoft infusion setUnomedical A/S
2023-11-29Z-0234-2024Class IVariSoft infusion setUnomedical A/S
2023-11-29Z-0320-2024Class IIMedtronic MoMedtronic Inc
2023-11-29Z-0321-2024Class IIMedtronic MoMedtronic Inc
2023-11-29Z-0322-2024Class IIMedtronic MoMedtronic Inc
2023-11-29Z-0323-2024Class IIDBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of…Musculoskeletal Transplant Foundation, Inc.
2023-11-29Z-0324-2024Class IISolea Models 2Convergent Dental
2023-11-29Z-0325-2024Class IIIRON assaySentinel CH SpA
2023-11-29Z-0326-2024Class IIAlinity c Iron ReagentSentinel CH SpA
2023-11-29Z-0327-2024Class IIBronchoscope-for endoscopy and endoscopic surgery within the airways…Aizu Olympus Co., Ltd.
2023-11-29Z-0328-2024Class IIBronchoscopeAizu Olympus Co., Ltd.
2023-11-29Z-0329-2024Class IIColonoscope: for endoscopy and endoscopic surgery within the lower…Aizu Olympus Co., Ltd.
2023-11-29Z-0330-2024Class IIICholeodochoscopeAizu Olympus Co., Ltd.
2023-11-29Z-0331-2024Class IICystonephroscope-endoscopic diagnosis and treatment within the bladderAizu Olympus Co., Ltd.
2023-11-29Z-0332-2024Class IIRhinolaryngoscope-for endoscopic diagnosis and treatment within the…Aizu Olympus Co., Ltd.
2023-11-29Z-0333-2024Class IIGastroscope-endoscopic ultrasoundAizu Olympus Co., Ltd.
2023-11-29Z-0334-2024Class IIGastrointestinal videoscope-indicated for use within the upper…Aizu Olympus Co., Ltd.
2023-11-29Z-0335-2024Class IIHysteroscope-For endoscopic diagnosis within the uterus Model Number:…Aizu Olympus Co., Ltd.
2023-11-29Z-0336-2024Class IIHysterovideoscope-For endoscopic diagnosis within the uterus Model…Aizu Olympus Co., Ltd.
2023-11-29Z-0337-2024Class IIHysterofiberscope-For endoscopic diagnosis within the uterusAizu Olympus Co., Ltd.
2023-11-29Z-0338-2024Class IITracheal fiberscope-airway managementAizu Olympus Co., Ltd.
2023-11-29Z-0339-2024Class IITracheal videoscope- For airway managementAizu Olympus Co., Ltd.
2023-11-29Z-0340-2024Class IIMobile airway scope-diagnosis and observation to access airway anatomyAizu Olympus Co., Ltd.
2023-11-29Z-0341-2024Class IIColonoscope-indicated for use within the lower digestive tractAizu Olympus Co., Ltd.
2023-11-29Z-0342-2024Class IISignmoidovideoscope-For endoscopy and endoscopic surgery within the…Aizu Olympus Co., Ltd.
2023-11-29Z-0343-2024Class IISmall intestinal videoscope-For endoscopy and endoscopic surgery…Aizu Olympus Co., Ltd.
2023-11-29Z-0344-2024Class IITransnasal esophagovideoscope-For endoscopy and endoscopic surgery…Aizu Olympus Co., Ltd.
2023-11-29Z-0345-2024Class IIUltrasonic gastrovideoscope-Real time ultrasound imagingAizu Olympus Co., Ltd.
2023-11-29Z-0346-2024Class IIDuodenovideoscope-EndoTherapy accessoriesAizu Olympus Co., Ltd.
2023-11-29Z-0347-2024Class IIUreteralscope- for endoscopic diagnosis and treatment within the…Aizu Olympus Co., Ltd.
2023-11-29Z-0348-2024Class IIUretero-reno fiberscope-For endoscopic diagnosis and treatment within…Aizu Olympus Co., Ltd.
2023-11-29Z-0349-2024Class IIBD Alaris Pump infusion setsBecton Dickinson & Company
2023-11-29Z-0350-2024Class IIBD gravity setsBecton Dickinson & Company
2023-11-29Z-0351-2024Class IIBD Extension SetsBecton Dickinson & Company
2023-11-29Z-0352-2024Class IITina-quant D-Dimer Test SystemRoche Diagnostics Operations, Inc.
2023-11-29Z-0353-2024Class IIFilmArray TORCH REF HTFA-ASY-0104BioFire Diagnostics, LLC
2023-11-29Z-0354-2024Class IIModel 97745 Controller used with Models 97715 and 97716 Intellis…Medtronic Neuromodulation
2023-11-29Z-0356-2024Class IIstryker Sage PrimaFit External Urine Management System for the Female…Sage Products Inc
2023-11-29Z-0357-2024Class IIGEM Premier 3000 PAKInstrumentation Laboratory
2023-11-29Z-0358-2024Class IIGEM Premier 3000 PAKInstrumentation Laboratory
2023-11-29Z-0359-2024Class IIGEM Premier 3000 PAKInstrumentation Laboratory
2023-11-29Z-0360-2024Class IIAVANOS BALLARD Closed Suction System for AdultsAvanos Medical, Inc.
2023-11-29Z-0361-2024Class IIVentlabSunMed Holdings, LLC
2023-11-29Z-0362-2024Class IIVentlabSunMed Holdings, LLC
2023-11-29Z-0363-2024Class IIVentlabSunMed Holdings, LLC
2023-11-29Z-0364-2024Class IIVentlabSunMed Holdings, LLC
2023-11-29Z-0365-2024Class IIVentlabSunMed Holdings, LLC
2023-11-29Z-0366-2024Class IIVentlabSunMed Holdings, LLC
2023-11-29Z-0367-2024Class IIVentlabSunMed Holdings, LLC
2023-11-29Z-0368-2024Class IICuraplex manual resuscitators with integrated manometerSunMed Holdings, LLC
2023-11-29Z-0369-2024Class IIMedline manual resuscitators with integrated manometerSunMed Holdings, LLC
2023-11-29Z-0370-2024Class IICompress Device Segmental Anchor PlugBiomet, Inc.
2023-11-29Z-0371-2024Class IICompress Device Segmental Anchor PlugBiomet, Inc.
2023-11-29Z-0372-2024Class IICompress Device Segmental Anchor PlugBiomet, Inc.
2023-11-29Z-0373-2024Class IICompress Device Segmental Anchor PlugBiomet, Inc.
2023-11-29Z-0374-2024Class IICompress Device Segmental Anchor PlugBiomet, Inc.
2023-11-29Z-0375-2024Class IICompress Device Segmental Anchor PlugBiomet, Inc.
2023-11-29Z-0376-2024Class IICompress Device Segmental Anchor PlugBiomet, Inc.
2023-11-29Z-0377-2024Class IICompress Device Segmental Anchor PlugBiomet, Inc.
2023-11-29Z-0378-2024Class IICompress Device Short Anchor PlugBiomet, Inc.
2023-11-29Z-0379-2024Class IICompress Device Short Anchor PlugBiomet, Inc.
2023-11-29Z-0380-2024Class IICompress Device Short Anchor PlugBiomet, Inc.
2023-11-29Z-0381-2024Class IICompress Device Short Anchor PlugBiomet, Inc.
2023-11-29Z-0382-2024Class IICompress Device Short Anchor PlugBiomet, Inc.
2023-11-29Z-0383-2024Class IICompress Device Short Anchor PlugBiomet, Inc.
2023-11-29Z-0384-2024Class IICompress Device Short Anchor PlugBiomet, Inc.
2023-11-29Z-0385-2024Class IICompress Device Short Anchor PlugBiomet, Inc.
2023-11-29Z-0386-2024Class IICompress Device Short Anchor PlugBiomet, Inc.
2023-11-29Z-0387-2024Class IICompress Device Short Anchor PlugBiomet, Inc.
2023-11-29Z-0388-2024Class IICompress Device Short Anchor PlugBiomet, Inc.
2023-11-29Z-0389-2024Class IIAchieva 1Philips North America Llc
2023-11-29Z-0390-2024Class IIAchieva 1Philips North America Llc
2023-11-29Z-0391-2024Class IIAchieva 1Philips North America Llc
2023-11-29Z-0392-2024Class IIIngenia 1Philips North America Llc
2023-11-29Z-0393-2024Class IIIntera 1Philips North America Llc
2023-11-29Z-0394-2024Class IIIntera 1Philips North America Llc
2023-11-29Z-0395-2024Class IISmartPath to dStream for 1Philips North America Llc
2023-11-29Z-0396-2024Class IIEXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 &…Boston Scientific Corporation
2023-11-29Z-0397-2024Class IIEXALT Model D Single-Use DuodenoscopeBoston Scientific Corporation
2023-11-29Z-0398-2024Class IIORION System with software OSS v6LEONI CIA CABLE SYSTEMS
2023-11-29Z-0399-2024Class IIORION System with software OSS v6LEONI CIA CABLE SYSTEMS
2023-11-22Z-0223-2024Class IIMobilett Mira wirelessSiemens Medical Solutions USA, Inc
2023-11-22Z-0291-2024Class IIAtrium Advanta V12 Covered Stent SystemAtrium Medical Corporation
2023-11-22Z-0292-2024Class IIBig Bore RT with software version V4Philips North America Llc
2023-11-22Z-0293-2024Class IIBrilliance CT Big Bore with software version V4Philips North America Llc
2023-11-22Z-0294-2024Class IIBrilliance CT Big Bore Oncology with software version V4Philips North America Llc
2023-11-22Z-0295-2024Class IIIBA Proton Therapy SystemIon Beam Applications S.A.
2023-11-22Z-0296-2024Class IILIFEPAK 15Physio-Control, Inc.
2023-11-22Z-0297-2024Class IILIFEPAK 15Physio-Control, Inc.
2023-11-22Z-0298-2024Class IILIFEPAK 15Physio-Control, Inc.
2023-11-22Z-0299-2024Class IILIFEPAK 15Physio-Control, Inc.
2023-11-22Z-0300-2024Class IILIFEPAK 15Physio-Control, Inc.
2023-11-22Z-0301-2024Class IILIFEPAK 15Physio-Control, Inc.
2023-11-22Z-0302-2024Class IILIFEPAK 15Physio-Control, Inc.
2023-11-22Z-0303-2024Class IILIFEPAK 15Physio-Control, Inc.
2023-11-22Z-0304-2024Class IILIFEPAK 15Physio-Control, Inc.
2023-11-22Z-0305-2024Class IILIFEPAK 15Physio-Control, Inc.
2023-11-22Z-0306-2024Class IISpectral CT on RailsPhilips North America
2023-11-22Z-0307-2024Class IIKWIKSTIKMicrobiologics Inc
2023-11-22Z-0308-2024Class IILYFO-DISKMicrobiologics Inc
2023-11-22Z-0309-2024Class IIAU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed…Beckman Coulter Biomedical Division
2023-11-22Z-0310-2024Class IIADLT BLOOD CULTURE COLLECT KITMEDLINE INDUSTRIES, LP - Northfield
2023-11-22Z-0311-2024Class IIPERIPHERAL BLOOD CULTURE DRAWMEDLINE INDUSTRIES, LP - Northfield
2023-11-22Z-0312-2024Class IICENTRAL LINE BLOOD CULTURE DRAMEDLINE INDUSTRIES, LP - Northfield
2023-11-22Z-0313-2024Class II24 BLOOD CULTURE KITMEDLINE INDUSTRIES, LP - Northfield
2023-11-22Z-0314-2024Class IIBLOOD CULTURE KITMEDLINE INDUSTRIES, LP - Northfield
2023-11-22Z-0315-2024Class IIRegard CV PKROi CPS LLC
2023-11-22Z-0316-2024Class IIOcean Water Seal Chest DrainsAtrium Medical Corporation
2023-11-22Z-0317-2024Class IIOasis Dry Suction Water Seal Chest DrainsAtrium Medical Corporation
2023-11-22Z-0318-2024Class IIExpress Dry Seal Chest DrainsAtrium Medical Corporation
2023-11-22Z-0319-2024Class IISpectral CT on RailsPhilips North America
2023-11-15Z-0128-2024Class IIFT1000S FLUID TRANSFER SETB. Braun Medical, Inc.
2023-11-15Z-0129-2024Class IISA3000 VENTED MICRO SPIKE ADAPTERB. Braun Medical, Inc.
2023-11-15Z-0130-2024Class IIAMO ADMINISTRATION SETB. Braun Medical, Inc.
2023-11-15Z-0131-2024Class II30 ML 2PORT BURETTE ASSEMBLYB. Braun Medical, Inc.
2023-11-15Z-0132-2024Class IITERUMO 60" TUBE SET W/HIGH CRACK CHK VLVB. Braun Medical, Inc.
2023-11-15Z-0133-2024Class IITHERASPHERE ADMIN SETB. Braun Medical, Inc.
2023-11-15Z-0134-2024Class IIALLERGAN UNIVERSAL FILL KITB. Braun Medical, Inc.
2023-11-15Z-0135-2024Class II30ML BURETTE ASSY WITH STOPCOCKB. Braun Medical, Inc.
2023-11-15Z-0136-2024Class IIBULK LARGEBORE MALE LL FITTINGB. Braun Medical, Inc.
2023-11-15Z-0151-2024Class INovum IQ Syringe infusion systemBaxter Healthcare Corporation
2023-11-15Z-0184-2024Class IBD Alaris PCU REF 8015CareFusion 303, Inc.
2023-11-15Z-0185-2024Class IBD Alaris Syringe ModuleCareFusion 303, Inc.
2023-11-15Z-0186-2024Class IAlaris PCA Module 8120CareFusion 303, Inc.
2023-11-15Z-0188-2024Class IStealthStation S8 Application version 2Medtronic Navigation, Inc.
2023-11-15Z-0189-2024Class IBRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150Olympus Corporation of the Americas
2023-11-15Z-0190-2024Class IEVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-ACOlympus Corporation of the Americas
2023-11-15Z-0191-2024Class IEVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180Olympus Corporation of the Americas
2023-11-15Z-0192-2024Class IEVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190Olympus Corporation of the Americas
2023-11-15Z-0193-2024Class IEVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190Olympus Corporation of the Americas
2023-11-15Z-0194-2024Class IEVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190Olympus Corporation of the Americas
2023-11-15Z-0218-2024Class IICardioMEMS Patient Electronic SystemSt. Jude Medical
2023-11-15Z-0219-2024Class IILeadCare II Blood Lead Test Kit-For in vitro diagnostic use onlyMagellan Diagnostics, Inc.
2023-11-15Z-0220-2024Class IIArial Water Resistant Pendant with Neck LanyardSecuritas Healthcare LLC
2023-11-15Z-0221-2024Class IIArial Water Resistant Pendant with WristbandSecuritas Healthcare LLC
2023-11-15Z-0222-2024Class IIArial Water Resistant Pendant with Long WristbandSecuritas Healthcare LLC
2023-11-15Z-0224-2024Class IIBV EnduraPhilips North America
2023-11-15Z-0226-2024Class IIZenition 50 & 70 Mobile Surgery C-armPhilips North America
2023-11-15Z-0227-2024Class IIIntegris-Allura IGTS Fixed SystemsPhilips North America
2023-11-15Z-0228-2024Class IIAllura Xper IGTS Fixed SystemsPhilips North America
2023-11-15Z-0229-2024Class IIAzurion IGTS Fixed SystemsPhilips North America
2023-11-15Z-0230-2024Class IIVeradius Unity Mobile Surgery C-armPhilips North America
2023-11-15Z-0231-2024Class IIBREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a…Breg Inc
2023-11-15Z-0235-2024Class IIZephyr Endobronchial ValvePulmonx, Corp.
2023-11-15Z-0236-2024Class IIVITROS Chemistry Products Lipase SlidesOrtho-Clinical Diagnostics, INc.
2023-11-15Z-0237-2024Class IIChange Healthcare Radiology SolutionsCHANGE HEALTHCARE CANADA COMPANY
2023-11-15Z-0238-2024Class IIFogarty Thru-Lumen Embolectomy CatheterEdwards Lifesciences, LLC
2023-11-15Z-0239-2024Class IIDisposable Spetzler-Malis Bipolar forcepsStryker Corporation
2023-11-15Z-0240-2024Class IIDisposable Spetzler-Malis Bipolar forcepsStryker Corporation
2023-11-15Z-0241-2024Class IIDisposable Spetzler-Malis Bipolar forcepsStryker Corporation
2023-11-15Z-0242-2024Class IIDisposable Spetzler-Malis Bipolar forcepsStryker Corporation
2023-11-15Z-0243-2024Class IIDisposable Spetzler-Malis Bipolar forcepsStryker Corporation
2023-11-15Z-0244-2024Class IIDisposable Spetzler-Malis Bipolar forcepsStryker Corporation
2023-11-15Z-0245-2024Class IIDisposable Spetzler-Malis Bipolar forcepsStryker Corporation
2023-11-15Z-0246-2024Class IIDisposable Spetzler-Malis Bipolar forcepsStryker Corporation
2023-11-15Z-0247-2024Class IIDisposable Spetzler-Malis Bipolar forcepsStryker Corporation
2023-11-15Z-0248-2024Class IIDisposable Spetzler-Malis Bipolar forcepsStryker Corporation
2023-11-15Z-0249-2024Class IIDisposable Spetzler-Malis Bipolar forcepsStryker Corporation
2023-11-15Z-0250-2024Class IIDisposable Spetzler-Malis Bipolar forcepsStryker Corporation
2023-11-15Z-0251-2024Class IIDisposable Spetzler-Malis Bipolar forcepsStryker Corporation
2023-11-15Z-0252-2024Class IIDisposable Spetzler-Malis Bipolar forcepsStryker Corporation
2023-11-15Z-0253-2024Class IIDisposable Spetzler-Malis Bipolar forcepsStryker Corporation
2023-11-15Z-0254-2024Class IIDisposable Spetzler-Malis Bipolar forcepsStryker Corporation
2023-11-15Z-0255-2024Class IIDisposable Spetzler-Malis Bipolar forcepsStryker Corporation
2023-11-15Z-0256-2024Class IIDisposable Spetzler-Malis Bipolar forcepsStryker Corporation
2023-11-15Z-0257-2024Class IIDisposable Spetzler-Malis Bipolar forcepsStryker Corporation
2023-11-15Z-0258-2024Class IIDJO EMPOWR Knee Punch HandleEncore Medical, LP
2023-11-15Z-0259-2024Class IIMonitron II Waveform AnalyzerPercussionaire Corporation
2023-11-15Z-0260-2024Class IIAlcon Custom-PakAlcon Research, LLC
2023-11-15Z-0261-2024Class IICLEARBLUE SMART COUNTDOWN PRGNCY TST 1CTFamily Dollar Stores, Llc.
2023-11-15Z-0262-2024Class IIAT HOME MARIJUANA TEST STRIPFamily Dollar Stores, Llc.
2023-11-15Z-0263-2024Class IIFIXODENT ORG CREAM 2Family Dollar Stores, Llc.
2023-11-15Z-0264-2024Class IIVERIQUICK PREGNANCY TEST 1CTFamily Dollar Stores, Llc.
2023-11-15Z-0265-2024Class IIDENTEMP ONE STEPFamily Dollar Stores, Llc.
2023-11-15Z-0266-2024Class IIFIRST RESPONSE 2 CTFamily Dollar Stores, Llc.
2023-11-15Z-0267-2024Class IIGOODSENSE DENTURE CLEANSER GRN TAB 40CTFamily Dollar Stores, Llc.
2023-11-15Z-0268-2024Class IIARC TEETH WHITENING PEN 0Family Dollar Stores, Llc.
2023-11-15Z-0269-2024Class IIMEDIC's CHOICE CONTACT LENS SOLUTION 12FLOZFamily Dollar Stores, Llc.
2023-11-15Z-0270-2024Class IIORAL B MOUTH SORE RINSE 237MLFamily Dollar Stores, Llc.
2023-11-15Z-0271-2024Class IICombiDiagnost R90Philips North America Llc
2023-11-15Z-0272-2024Class IIDigitalDiagnost 4 Chest/EmergencyPhilips North America Llc
2023-11-15Z-0273-2024Class IIDigitalDiagnost 4 Flex/ValuePhilips North America Llc
2023-11-15Z-0274-2024Class IIDigitalDiagnost 4 High PerformancePhilips North America Llc
2023-11-15Z-0275-2024Class IIDigitalDiagnost C90 Flex/Value/Chest/ERPhilips North America Llc
2023-11-15Z-0276-2024Class IIDigitalDiagnost C90 High PerformancePhilips North America Llc
2023-11-15Z-0277-2024Class IIDigitalDiagnost C90 Release 3Philips North America Llc
2023-11-15Z-0278-2024Class IIDigitalDiagnost C90 Release 3Philips North America Llc
2023-11-15Z-0279-2024Class IIEasyDiagnost Eleva DRFPhilips North America Llc
2023-11-15Z-0280-2024Class IIProxiDiagnost N90Philips North America Llc
2023-11-15Z-0281-2024Class IIRSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4Encore Medical, LP
2023-11-15Z-0282-2024Class IIRSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mmEncore Medical, LP
2023-11-15Z-0283-2024Class IIPhilips EPIQ Diagnostic Ultrasound System Models: EPIQ 7GPhilips Ultrasound, Inc.
2023-11-15Z-0284-2024Class IIPhilips Affiniti 70Philips Ultrasound, Inc.
2023-11-15Z-0285-2024Class IICONTRA GRAYYoung Dental Manufacturing I, LLC
2023-11-15Z-0286-2024Class ICordis ANGIOGRAPHIC CATHETERIZATION SETSCordis US Corp
2023-11-15Z-0287-2024Class IIStrykerStryker Corporation
2023-11-15Z-0288-2024Class IIEVIS EXERA III Gastrointestinal VideoscopeOlympus Corporation of the Americas
2023-11-15Z-0289-2024Class IIThe DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray…Carestream Health, Inc.
2023-11-15Z-0290-2024Class IICardiohelp-iMaquet Medical Systems USA
2023-11-08Z-0144-2024Class IStolen McGRATH MAC Video LaryngoscopesCovidien

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