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Medical device recalls reported in 2021

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ReportedRecallClassProductFirm
2021-09-15Z-2392-2021Class ILiquaSonic Ultrasound Gel 5LAthena Medical Products Inc
2021-09-15Z-2402-2021Class IPipeline Flex Embolization DeviceMicro Therapeutics Inc,
2021-09-15Z-2403-2021Class IEV3 Pipeline Flex Embolization Device with Flex Shield TechnologyMicro Therapeutics Inc,
2021-09-15Z-2411-2021Class IIIngenia 1Philips North America Llc
2021-09-15Z-2412-2021Class IIIngenia 1Philips North America Llc
2021-09-15Z-2413-2021Class IIIngenia 1Philips North America Llc
2021-09-15Z-2414-2021Class IIIngenia 1Philips North America Llc
2021-09-15Z-2415-2021Class IISmartPath to dStream for 1Philips North America Llc
2021-09-15Z-2416-2021Class IIIngenia Ambition S-a Magnetic Resonance Medical Electrical Systems…Philips North America Llc
2021-09-15Z-2417-2021Class IIIngenia 3Philips North America Llc
2021-09-15Z-2418-2021Class IIIngenia Elition S-a Magnetic Resonance Medical Electrical Systems…Philips North America Llc
2021-09-15Z-2419-2021Class IIIngenia Elition X-a Magnetic Resonance Medical Electrical Systems…Philips North America Llc
2021-09-15Z-2420-2021Class IIIngenia 3Philips North America Llc
2021-09-15Z-2421-2021Class IISmartPath to dStream for XR and 3Philips North America Llc
2021-09-15Z-2422-2021Class IIIngenia Ambition X- Magnetic Resonance Medical Electrical Systems…Philips North America Llc
2021-09-15Z-2423-2021Class IIArc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8Olympus Corporation of the Americas
2021-09-15Z-2424-2021Class IIAtellica IM BR 27Siemens Healthcare Diagnostics, Inc
2021-09-15Z-2425-2021Class IIAtellica IM BR 27Siemens Healthcare Diagnostics, Inc
2021-09-15Z-2426-2021Class IIAtellica IM BR 27Siemens Healthcare Diagnostics, Inc
2021-09-15Z-2427-2021Class IIPhilipsPhilips North America LLC
2021-09-15Z-2434-2021Class IIProteus 235- designed to produce and deliver a proton beam for the…Ion Beam Applications S.A.
2021-09-15Z-2435-2021Class IINihon Kohden NKV-550 VentilatorNIHON KOHDEN ORANGEMED, INC
2021-09-15Z-2436-2021Class IISolero Generator Refurbished US PGAngiodynamics, Inc.
2021-09-15Z-2437-2021Class IISolero Generator US PGAngiodynamics, Inc.
2021-09-15Z-2438-2021Class IISolero Generator Refurbished PGAngiodynamics, Inc.
2021-09-15Z-2439-2021Class IISolero Generator PGAngiodynamics, Inc.
2021-09-15Z-2440-2021Class IICOPAN FLOQSwabsCopan Italia
2021-09-15Z-2441-2021Class IIMIVI Super 90 Guide CathetersMivi Neuroscience Inc
2021-09-15Z-2442-2021Class IIMIVI Super 90 8F Guide CatheterMivi Neuroscience Inc
2021-09-08Z-2357-2021Class IICombiDiagnost R90 Software Version R1Philips Medical Systems Gmbh, DMC
2021-09-08Z-2358-2021Class IIPalindrome RT Chronic Catheter Kit Symmetrical TipCovidien, LP
2021-09-08Z-2359-2021Class IIPalindrome RT Chronic Catheter Kit Symmetrical TipCovidien, LP
2021-09-08Z-2360-2021Class IIPalindrome RT Chronic Catheter Kit Symmetrical TipCovidien, LP
2021-09-08Z-2361-2021Class IIPalindrome RT Chronic Catheter Kit Symmetrical TipCovidien, LP
2021-09-08Z-2362-2021Class IIPalindrome RT Chronic Catheter Kit Symmetrical TipCovidien, LP
2021-09-08Z-2363-2021Class IIPalindrome RT Chronic Catheter Kit Symmetrical TipCovidien, LP
2021-09-08Z-2364-2021Class IIPalindrome RT Repair Kit 15 FR TAL 19cmCovidien, LP
2021-09-08Z-2365-2021Class IIPalindrome RT Repair Kit 15 FR TAL 23cmCovidien, LP
2021-09-08Z-2366-2021Class IIPalindrome RT Repair Kit 15 FR TAL 28cmCovidien, LP
2021-09-08Z-2367-2021Class IIPalindrome RT Repair Kit 15 FR TAL 33cmCovidien, LP
2021-09-08Z-2368-2021Class IIPalindrome RT Repair Kit 15 FR TAL 44cmCovidien, LP
2021-09-08Z-2369-2021Class IIPalindrome RT Repair Kit 15 FR TAL 55cmCovidien, LP
2021-09-08Z-2370-2021Class IIPalindrome Precision RT Chronic Catheter Kit Symmetrical TipCovidien, LP
2021-09-08Z-2371-2021Class IIPalindrome Precision RT Chronic Catheter Kit Symmetrical TipCovidien, LP
2021-09-08Z-2372-2021Class IIPalindrome Precision RT Chronic Catheter Kit Symmetrical TipCovidien, LP
2021-09-08Z-2373-2021Class IIPalindrome Precision RT Chronic Catheter Kit Symmetrical TipCovidien, LP
2021-09-08Z-2374-2021Class IIPalindrome Precision RT Chronic Catheter Kit Symmetrical TipCovidien, LP
2021-09-08Z-2375-2021Class IIPalindrome Precision RT Chronic Catheter Kit Symmetrical TipCovidien, LP
2021-09-08Z-2378-2021Class IIBaxter PrismaFlexBaxter Healthcare Corporation
2021-09-08Z-2379-2021Class IIBaxter prismaflexBaxter Healthcare Corporation
2021-09-08Z-2380-2021Class IIGyrus Acmi PKS Omni 5mm/33cm-intended for the electrosurgical…Olympus Corporation of the Americas
2021-09-08Z-2381-2021Class IIEL-Anti-SARS-CoV-2 IgM KitThera Test Laboratories, Inc.
2021-09-08Z-2382-2021Class IIEL-Anti-SARS-CoV-2 IgG KitThera Test Laboratories, Inc.
2021-09-08Z-2383-2021Class IICoolSculpting Elite System The CoolSculpting System SW release 2Zeltiq Aesthetics, Inc
2021-09-08Z-2384-2021Class IIMY01 Continuous Compartmental Pressure MonitorMY01, INC.
2021-09-08Z-2385-2021Class IIDIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEMCardiovascular Systems Inc
2021-09-08Z-2386-2021Class IISTEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEMCardiovascular Systems Inc
2021-09-08Z-2387-2021Class IIMerge HemoMerge Healthcare, Inc.
2021-09-08Z-2388-2021Class IIJessie Sterile Arm Suspension KitAspen Surgical Products, Inc.
2021-09-08Z-2389-2021Class IIMarco Shoulder Stabilization KitAspen Surgical Products, Inc.
2021-09-08Z-2390-2021Class IINorton Arm KitAspen Surgical Products, Inc.
2021-09-08Z-2393-2021Class IISteripath Luer Transport PackMagnolia Medical Technologies, Inc.
2021-09-08Z-2394-2021Class IITRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments…DePuy Orthopaedics, Inc.
2021-09-08Z-2395-2021Class IITRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments…DePuy Orthopaedics, Inc.
2021-09-08Z-2396-2021Class IITRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments…DePuy Orthopaedics, Inc.
2021-09-08Z-2397-2021Class IITRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments…DePuy Orthopaedics, Inc.
2021-09-08Z-2398-2021Class IITRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments…DePuy Orthopaedics, Inc.
2021-09-08Z-2399-2021Class IITRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments…DePuy Orthopaedics, Inc.
2021-09-08Z-2400-2021Class IITRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments…DePuy Orthopaedics, Inc.
2021-09-08Z-2401-2021Class IIsmiths medical portex Tracheal Intubation StyletSmiths Medical ASD Inc.
2021-09-08Z-2404-2021Class IIArtis Models with SW version VD12 listed below: Artis zee floor…Siemens Medical Solutions USA, Inc
2021-09-08Z-2405-2021Class IILase DiscectomLase Discectomy Device KitClarus Medical, Llc
2021-09-08Z-2406-2021Class IIMonaco RTP SystemElekta Inc
2021-09-08Z-2407-2021Class IICareStart COVID-19 Antigen Rapid Diagnostic Test for the detection of…Versea Diagnostics LLC
2021-09-08Z-2408-2021Class IIFaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and…Versea Diagnostics LLC
2021-09-08Z-2409-2021Class IIHealgen COVID-19 IgG/IgM Rapid Test CassetteVersea Diagnostics LLC
2021-09-08Z-2410-2021Class IIStatus COVID-19/Flu Rapid Immunoassay for Direct Detection and…Versea Diagnostics LLC
2021-09-01Z-2284-2021Class IMonoject 0Cardinal Health
2021-09-01Z-2285-2021Class IMonoject 0Cardinal Health
2021-09-01Z-2286-2021Class IMonoject 0Cardinal Health
2021-09-01Z-2330-2021Class IIAQUABEAM HandpiecePROCEPT BIOROBOTICS CORPORATION
2021-09-01Z-2331-2021Class IIAltiVate Anatomic Shoulder System for the following Part Numbers: 1Encore Medical, LP
2021-09-01Z-2332-2021Class IINormand Remisol Advance Data ManagerBeckman Coulter Inc.
2021-09-01Z-2333-2021Class IIBD" Mouse IgG2a Isotype Control APC X39 ASRBecton, Dickinson and Company, BD Biosciences
2021-09-01Z-2334-2021Class IINES Reprocessed Visions PVNortheast Scientific Inc.
2021-09-01Z-2335-2021Class IIAUGMENT Injectable KitBioMimetic Therapeutics, LLC
2021-09-01Z-2336-2021Class IIKeyPrint Soft- bottleStraumann USA LLC
2021-09-01Z-2337-2021Class IIECHELON MRI SystemHitachi Healthcare Americas Corporation
2021-09-01Z-2338-2021Class IIECHELON Oval MRI SystemHitachi Healthcare Americas Corporation
2021-09-01Z-2339-2021Class IIOASIS MRI SystemHitachi Healthcare Americas Corporation
2021-09-01Z-2340-2021Class IIGore Molding & Occlusion Balloon CatheterW. L. Gore & Associates Inc.
2021-09-01Z-2341-2021Class IIIngenia 1Philips North America Llc
2021-09-01Z-2342-2021Class IIIngenia 1Philips North America Llc
2021-09-01Z-2343-2021Class IIIngenia 3Philips North America Llc
2021-09-01Z-2344-2021Class IIIngenia Elition X-Magnetic Resonance Medical Electrical Systems…Philips North America Llc
2021-09-01Z-2345-2021Class IIIngenia CX 3Philips North America Llc
2021-09-01Z-2346-2021Class IIAchieva 3Philips North America Llc
2021-09-01Z-2347-2021Class IIIngenia Elition S-Magnetic Resonance Medical Electrical Systems…Philips North America Llc
2021-09-01Z-2348-2021Class IIATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee…DePuy Orthopaedics, Inc.
2021-09-01Z-2349-2021Class IIVascular Table without FowlerOakworks Inc
2021-09-01Z-2350-2021Class IITerumo Advanced Perfusion System 1 Electronic Patient Gas System…Terumo Cardiovascular Systems Corporation
2021-09-01Z-2351-2021Class IIAccu-Chek Aviva Plus Test StripRoche Diabetes Care, Inc.
2021-09-01Z-2352-2021Class IIAccu-Chek Performa Test StripRoche Diabetes Care, Inc.
2021-09-01Z-2353-2021Class IIAccu-Chek SmartView Test StripRoche Diabetes Care, Inc.
2021-09-01Z-2354-2021Class IIAccu-Chek Inform II Test StripRoche Diabetes Care, Inc.
2021-09-01Z-2355-2021Class IIHARMONIC HD 1000i ShearsEthicon Endo-Surgery Inc
2021-09-01Z-2356-2021Class IIHARMONICHD 1000i ShearsEthicon Endo-Surgery Inc
2021-08-25Z-2244-2021Class IArgyle UVC Insertion Tray containing Safety Scalpel N11Cardinal Health 200, LLC
2021-08-25Z-2287-2021Class IITrilogy EvoPhilips Respironics, Inc.
2021-08-25Z-2288-2021Class IITrilogy Evo O2Philips Respironics, Inc.
2021-08-25Z-2289-2021Class IITrilogy EV300Philips Respironics, Inc.
2021-08-25Z-2290-2021Class IITrilogy Evo UniversalPhilips Respironics, Inc.
2021-08-25Z-2291-2021Class IIThe Aequalis Pyrocarbon Humeral HeadsTornier S.A.S.
2021-08-25Z-2292-2021Class IIGore Propaten Vascular Graft configured for Pediatric ShuntW L Gore & Associates, Inc.
2021-08-25Z-2293-2021Class IIGore Propaten Vascular Graft configured for Pediatric ShuntW L Gore & Associates, Inc.
2021-08-25Z-2294-2021Class IISoltive Premium Super Pulsed Laser SystemOlympus Corporation of the Americas
2021-08-25Z-2295-2021Class IIDELTAVEN Safety IDelta Med SpA
2021-08-25Z-2296-2021Class IIDELTAVEN Y DNL Safety IDelta Med SpA
2021-08-25Z-2297-2021Class IIDELTAVEN FASTFLASHDelta Med SpA
2021-08-25Z-2298-2021Class IIDELTAVEN YDelta Med SpA
2021-08-25Z-2299-2021Class IINEO DELTA Self SafeDelta Med SpA
2021-08-25Z-2300-2021Class IINEO DELTA Self Safe 1Delta Med SpA
2021-08-25Z-2301-2021Class IINEO DELTA Self Safe TDelta Med SpA
2021-08-25Z-2302-2021Class IINEO DELTA SELFSAFE PUR 1Delta Med SpA
2021-08-25Z-2303-2021Class IINEO DELTA SELFSAFE PUR TDelta Med SpA
2021-08-25Z-2304-2021Class IINEO DELTA SELFSAFE PUR TDelta Med SpA
2021-08-25Z-2305-2021Class IIWOLF-PAK Self Safe Safety IV Catheter: a) REF PIVD2010W b) REF…Delta Med SpA
2021-08-25Z-2306-2021Class IIEPIQ Ultrasound SystemsPhilips Ultrasound Inc
2021-08-25Z-2307-2021Class IIOxygen Sensor Model K54019-2 used in the: G185 & G210 Incubators and…CooperSurgical, Inc.
2021-08-25Z-2308-2021Class IIModel L43K Intraoperative Probe-For the diagnostic ultrasound…Hitachi Healthcare Americas Corporation
2021-08-25Z-2309-2021Class IIFLASH Ostial SystemOstial Corporation
2021-08-25Z-2310-2021Class IIOPTI SARS-CoV-2 RT-PCR TestOPTI Medical Systems, Inc
2021-08-25Z-2311-2021Class IIICell Marque AntibodiesCell Marque Corporation
2021-08-25Z-2312-2021Class IINEO-KATH Epidural Catheter SetEpimed International
2021-08-25Z-2313-2021Class IINEO-KATHEpimed International
2021-08-25Z-2314-2021Class II728306 Brilliance iCT-Computed Tomography X-ray systems 728305…Philips North America Llc
2021-08-25Z-2315-2021Class IIModel 728321/728323 CT5000 Ingenuity Plus/Pro/Premium-Computed…Philips North America Llc
2021-08-25Z-2316-2021Class II728327 Ingenuity CT Upgrades-Computed Tomography X-ray systemPhilips North America Llc
2021-08-25Z-2317-2021Class II728332 IQon Spectral CT-Computed Tomography X-ray systemPhilips North America Llc
2021-08-25Z-2318-2021Class II728333 Spectral CT 7500 -Computed Tomography X-ray systemPhilips North America Llc
2021-08-25Z-2319-2021Class IIRUSCH Slick Set Cuffed Endotracheal Tube and Stylet SetTeleflex Medical Europe Ltd
2021-08-25Z-2320-2021Class IIRUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet SetTeleflex Medical Europe Ltd
2021-08-25Z-2321-2021Class IIRUSCH Endotracheal Tube oral/nasal MagillTeleflex Medical Europe Ltd
2021-08-25Z-2322-2021Class IIRUSCH Endotracheal Tube oral/nasal Murphy EyeTeleflex Medical Europe Ltd
2021-08-25Z-2323-2021Class IICytocell LPH019-A E2ACytocell Ltd.
2021-08-25Z-2324-2021Class IICIRCUL8 LUXE DVT PREVENTION DEVICEOrtho8, Inc.
2021-08-25Z-2325-2021Class IIEVEXIA LUXE DVT PREVENTION DEVICEOrtho8, Inc.
2021-08-25Z-2326-2021Class IIECHELON FLEX Powered Plus Stapler-intended for transectionEthicon Endo-Surgery Inc
2021-08-25Z-2327-2021Class IITheraSphere Administration SetBoston Scientific Corporation
2021-08-25Z-2328-2021Class IITheraSphere Administration SetBoston Scientific Corporation
2021-08-25Z-2329-2021Class IITriathlon Prim CEM FXD BPLT 7Howmedica Osteonics Corp.
2021-08-18Z-2110-2021Class ISpectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation
2021-08-18Z-2165-2021Class IDose IQ Safety Software used with Spectrum IQ Infusion PumpBaxter Healthcare Corporation
2021-08-18Z-2188-2021Class IHeartWare HVAD Pump Implant KitHeartware, Inc.
2021-08-18Z-2189-2021Class IHeartWare HVAD Pump Implant KitHeartware, Inc.
2021-08-18Z-2190-2021Class IHeartWare HVAD Pump Implant KitHeartware, Inc.
2021-08-18Z-2191-2021Class IHeartWare HVAD Pump Implant KitHeartware, Inc.
2021-08-18Z-2192-2021Class IHeartWare HVAD Driveline Extension CableHeartware, Inc.
2021-08-18Z-2193-2021Class IHeartWare HVAD Driveline Extension CableHeartware, Inc.
2021-08-18Z-2194-2021Class IHeartWare HVAD Implant KitHeartware, Inc.
2021-08-18Z-2195-2021Class IHeartWare HVAD Implant KitHeartware, Inc.
2021-08-18Z-2196-2021Class IHeartWare HVAD Outflow GraftHeartware, Inc.
2021-08-18Z-2197-2021Class IHeartWare HVAD Pump AccessoriesHeartware, Inc.
2021-08-18Z-2204-2021Class IAlaris Infusion Pump ModuleBioMedical Equipment Service Co (BMES)
2021-08-18Z-2205-2021Class IITransport Stretcher 747Stryker Medical Division of Stryker Corporation
2021-08-18Z-2206-2021Class IISurgistool-intended to support a healthcare professional during…Stryker Medical Division of Stryker Corporation
2021-08-18Z-2207-2021Class IIPrime Fifth Wheel Stretcher-stretcher may be used for minor…Stryker Medical Division of Stryker Corporation
2021-08-18Z-2208-2021Class IIPrime Big Wheel Stretcher-used as a short-term outpatient clinical…Stryker Medical Division of Stryker Corporation
2021-08-18Z-2209-2021Class IIPrime TC-transport chair intended for medical purposes to assist a…Stryker Medical Division of Stryker Corporation
2021-08-18Z-2210-2021Class IIInTouch 2131-intended to support a human patient in an acute care…Stryker Medical Division of Stryker Corporation
2021-08-18Z-2211-2021Class IIProform- support surface is used to assist in the prevention and…Stryker Medical Division of Stryker Corporation
2021-08-18Z-2212-2021Class IIComfortGelStryker Medical Division of Stryker Corporation
2021-08-18Z-2213-2021Class IIIsoGel AirStryker Medical Division of Stryker Corporation
2021-08-18Z-2214-2021Class IIS3 MedSurg BedStryker Medical Division of Stryker Corporation
2021-08-18Z-2215-2021Class IIIsolibrium Support SurfaceStryker Medical Division of Stryker Corporation
2021-08-18Z-2216-2021Class IIS3 MedSurg BedStryker Medical Division of Stryker Corporation
2021-08-18Z-2217-2021Class IITruRize Clinical ChairStryker Medical Division of Stryker Corporation
2021-08-18Z-2218-2021Class IISymmetry Plus Treatment ReclinerStryker Medical Division of Stryker Corporation
2021-08-18Z-2219-2021Class IIMichael Graves with Stryker Highback Chair-intended for pediatric and…Stryker Medical Division of Stryker Corporation
2021-08-18Z-2220-2021Class IIStretcher Chair-for use in all acute care hospitals and medical…Stryker Medical Division of Stryker Corporation
2021-08-18Z-2221-2021Class IICUB Pediatric Crib- intended to provide a pediatric patient support…Stryker Medical Division of Stryker Corporation
2021-08-18Z-2222-2021Class IIElectric MedSurg Bed FL23Stryker Medical Division of Stryker Corporation
2021-08-18Z-2223-2021Class IIGoBed II MedSurg BedStryker Medical Division of Stryker Corporation
2021-08-18Z-2224-2021Class IICODMAN RANEY SCALP CLIPS-Disposable cylindrical clips designed to…Integra LifeSciences Corp.
2021-08-18Z-2225-2021Class IIMYLA softwareBioMerieux SA
2021-08-18Z-2226-2021Class IIETEST IMIPENEM RELEBACTAMBiomerieux Inc
2021-08-18Z-2227-2021Class IIChassis LabelCarl Zeiss Meditec, Inc.
2021-08-18Z-2228-2021Class IIMedtronic StimLoc Burr Hole CoverMedtronic Neuromodulation
2021-08-18Z-2229-2021Class IIGrasper/RetrieverShent USA, Inc.
2021-08-18Z-2230-2021Class IIGrasper/RetrieverShent USA, Inc.
2021-08-18Z-2231-2021Class IIMedline Shoulder CDS convenience kitsMedline Industries Inc
2021-08-18Z-2232-2021Class IIMedline Knee Arthroscopy KitMedline Industries Inc
2021-08-18Z-2233-2021Class IIMedline Total KneeMedline Industries Inc
2021-08-18Z-2234-2021Class IIMedline Arthroscopy KitMedline Industries Inc
2021-08-18Z-2235-2021Class IICordis SABER PTA Balloon Dilation CatheterCordis Corporation
2021-08-18Z-2236-2021Class IICannulated graduated drill bit 1NEOSTEO
2021-08-18Z-2237-2021Class IIAdvance Dx 100 Blood Collection Card Quantity 25 REF CMT01 Advance Dx…Advance Dx, Inc.
2021-08-18Z-2238-2021Class IIPrelude SNAP Splittable Sheath IntroducerMerit Medical Systems, Inc.
2021-08-18Z-2239-2021Class IIPrelude SNAP Splittable Sheath IntroducerMerit Medical Systems, Inc.
2021-08-18Z-2240-2021Class IICovidien Sonicision Reusable Generator-converts electrical power from…Covidien Llc

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