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Medical device recalls reported in 2022

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ReportedRecallClassProductFirm
2022-12-14Z-0406-2023Class IICareFusion VCarefusion 2200 Inc
2022-12-14Z-0407-2023Class IICareFusion VCarefusion 2200 Inc
2022-12-14Z-0408-2023Class IICareFusion VCarefusion 2200 Inc
2022-12-14Z-0409-2023Class IICareFusion VCarefusion 2200 Inc
2022-12-14Z-0410-2023Class IICareFusion VCarefusion 2200 Inc
2022-12-14Z-0411-2023Class IICareFusion VCarefusion 2200 Inc
2022-12-14Z-0412-2023Class IICareFusion VCarefusion 2200 Inc
2022-12-14Z-0413-2023Class IICareFusion VCarefusion 2200 Inc
2022-12-14Z-0414-2023Class IICareFusion VCarefusion 2200 Inc
2022-12-14Z-0415-2023Class IICareFusion VCarefusion 2200 Inc
2022-12-14Z-0416-2023Class IICareFusion VCarefusion 2200 Inc
2022-12-14Z-0417-2023Class IICareFusion VCarefusion 2200 Inc
2022-12-14Z-0418-2023Class IILineSider Spinal System 5Integrity Implants Inc.
2022-12-14Z-0419-2023Class IILineSider Spinal System 5Integrity Implants Inc.
2022-12-14Z-0420-2023Class IILineSider Spinal System 5Integrity Implants Inc.
2022-12-14Z-0421-2023Class IILineSider Spinal System pedicle screwsIntegrity Implants Inc.
2022-12-14Z-0422-2023Class IIFlow-c Anesthesia SystemGetinge Usa Sales Inc
2022-12-14Z-0423-2023Class IIOmnipod 5 Automated Insulin Delivery System Product catalog numbers:…Insulet Corporation
2022-12-14Z-0424-2023Class IIHF Resection ElectrodesOlympus Corporation of the Americas
2022-12-14Z-0425-2023Class IIThe FAST System and the FAST PBC Prep Cartridge together are a closedQvella Corporation
2022-12-14Z-0458-2023Class IIPropel Mini Mometasone Furoate Sinus ImplantIntersect ENT, Inc.
2022-12-14Z-0459-2023Class IIPhilips Ingenia Elition S MR SystemPhilips North America Llc
2022-12-14Z-0460-2023Class IIPhilips Ingenia Elition X MR SystemPhilips North America Llc
2022-12-14Z-0461-2023Class IIPhilips SmartPath to Ingenia Elition X MR SystemPhilips North America Llc
2022-12-14Z-0462-2023Class IIPhilips MR 7700 SystemPhilips North America Llc
2022-12-14Z-0463-2023Class IIPhilips Upgrade to MR 7700 SystemPhilips North America Llc
2022-12-14Z-0464-2023Class IIMedical Action Industries IncMedical Action Industries, Inc. 306
2022-12-14Z-0465-2023Class IISmall Joint OATS SetArthrex, Inc.
2022-12-07Z-0324-2023Class IICoViPoint COVID test kitGS Biomark LLC
2022-12-07Z-0325-2023Class IIBusse JOINT INJECTION TRAY -Intended as a nerve block REF NoBusse Hospital Disposables, Inc.
2022-12-07Z-0326-2023Class IIBusse SPINE INJECTION TRAY-Intended as a nerve block REF NoBusse Hospital Disposables, Inc.
2022-12-07Z-0340-2023Class IIINTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci…Intuitive Surgical, Inc.
2022-12-07Z-0341-2023Class IICytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific…Cytocell Ltd.
2022-12-07Z-0342-2023Class IICMV IgM EIABio-Rad Laboratories, Inc.
2022-12-07Z-0343-2023Class IIAero Blue Performance Surgical GownOwens & Minor Distribution, Inc.
2022-12-07Z-0344-2023Class IIMobiCT-32 AIRO Mobile CT ScannerMobius Imaging, LLC
2022-12-07Z-0345-2023Class IIAccelerate PhenoTest BC kit REF 10101018Accelerate Diagnostics Inc
2022-12-07Z-0346-2023Class IIAccelerate PhenoTest BC kit REF 10102018Accelerate Diagnostics Inc
2022-12-07Z-0347-2023Class IIGREER MGreer Laboratories, Inc.
2022-12-07Z-0348-2023Class IIGREER DIAGreer Laboratories, Inc.
2022-12-07Z-0349-2023Class IIIAPrimus Corporation dba Trinity Biotech
2022-12-07Z-0350-2023Class IIITrinity Biotech HbA1cPrimus Corporation dba Trinity Biotech
2022-12-07Z-0353-2023Class IICytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation…Cytocell Ltd.
2022-12-07Z-0354-2023Class IIAlcon Custom Pak Surgical Procedure PackAlcon Research, LLC
2022-11-30Z-0236-2023Class IMighty Bliss Electric Heating PadWhele LLC DBA Perch
2022-11-30Z-0237-2023Class IMighty Bliss Electric Heating PadWhele LLC DBA Perch
2022-11-30Z-0238-2023Class IMighty Bliss Electric Heating PadWhele LLC DBA Perch
2022-11-30Z-0247-2023Class II3M Steri-Drape3M Healthcare Business
2022-11-30Z-0248-2023Class II3M Steri-Drape3M Healthcare Business
2022-11-30Z-0249-2023Class II3M Steri-Drape3M Healthcare Business
2022-11-30Z-0250-2023Class II3M Steri-Drape3M Healthcare Business
2022-11-30Z-0251-2023Class II3M Steri-Drape3M Healthcare Business
2022-11-30Z-0252-2023Class II3M Steri-Drape3M Healthcare Business
2022-11-30Z-0253-2023Class II3M Steri-Drape3M Healthcare Business
2022-11-30Z-0254-2023Class II3M Steri-Drape3M Healthcare Business
2022-11-30Z-0255-2023Class II3M Steri-Drape3M Healthcare Business
2022-11-30Z-0256-2023Class II3M Steri-Drape3M Healthcare Business
2022-11-30Z-0257-2023Class II3M Steri-Drape3M Healthcare Business
2022-11-30Z-0258-2023Class II3M Steri-Drape3M Healthcare Business
2022-11-30Z-0259-2023Class II3M Steri-Drape3M Healthcare Business
2022-11-30Z-0260-2023Class II3M Steri-Drape3M Healthcare Business
2022-11-30Z-0261-2023Class II3M Steri-Drape3M Healthcare Business
2022-11-30Z-0262-2023Class II3M Steri-Drape3M Healthcare Business
2022-11-30Z-0263-2023Class II3M Steri-Drape3M Healthcare Business
2022-11-30Z-0264-2023Class II3M Steri-Drape3M Healthcare Business
2022-11-30Z-0265-2023Class IIBMedical Action Industries, Inc. 306
2022-11-30Z-0266-2023Class IIInControl Insulin SyringesAllison Medical, Inc.
2022-11-30Z-0267-2023Class IIHamilton-C6Hamilton Medical AG
2022-11-30Z-0268-2023Class IIAlinity m SystemAbbott Molecular, Inc.
2022-11-30Z-0269-2023Class IIMicroScan autoSCAN-4 InstrumentBeckman Coulter, Inc.
2022-11-30Z-0270-2023Class IIeSuction Small CavityEndo-Therapeutics, Inc.
2022-11-30Z-0271-2023Class IIK-ASSAY IgA Immunoturbidimetric AssayKamiya Biomedical Company, LLC
2022-11-30Z-0272-2023Class IIMedfusion Model 4000 Syringe Infusion PumpSmiths Medical ASD Inc.
2022-11-30Z-0273-2023Class IIUnity Total Knee SystemCorin Ltd
2022-11-30Z-0274-2023Class IIBASIN SETAmerican Contract Systems, Inc.
2022-11-30Z-0278-2023Class IIPAJUNK Continuous Epidural TrayPajunk Medical Systems, L.P.
2022-11-30Z-0279-2023Class IISouthmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADESouthmedic, Inc.
2022-11-30Z-0280-2023Class IIVS3 Iridium Visionsense InfraredVisionsense, Ltd.
2022-11-30Z-0281-2023Class IIVS3 IridiumVisionsense, Ltd.
2022-11-30Z-0282-2023Class IIVS3 Iridium Visionsense InfraredVisionsense, Ltd.
2022-11-30Z-0283-2023Class IIregard LAMINECTOMYROi CPS LLC
2022-11-30Z-0284-2023Class IIregard FOOT PACKROi CPS LLC
2022-11-30Z-0285-2023Class IIregard TOTAL JOINTROi CPS LLC
2022-11-30Z-0286-2023Class IIregard KYPHOPLASTYROi CPS LLC
2022-11-30Z-0287-2023Class IIregard BASIC NEUROROi CPS LLC
2022-11-30Z-0288-2023Class IIregard BASIC NEUROROi CPS LLC
2022-11-30Z-0289-2023Class IIregard SPINE PACKROi CPS LLC
2022-11-30Z-0290-2023Class IIregard VITRECTOMY PACKROi CPS LLC
2022-11-30Z-0291-2023Class IIregard NEURO PACKROi CPS LLC
2022-11-30Z-0292-2023Class IIregard CERVICAL PACKROi CPS LLC
2022-11-30Z-0293-2023Class IIregard MAJOR EARROi CPS LLC
2022-11-30Z-0294-2023Class IIregard SHOULDER W BCH CHAIRROi CPS LLC
2022-11-30Z-0295-2023Class IIregard SPINE PACKROi CPS LLC
2022-11-30Z-0296-2023Class IIregard HAND PACKROi CPS LLC
2022-11-30Z-0297-2023Class IIregard ACDFROi CPS LLC
2022-11-30Z-0298-2023Class IIregard ACDFROi CPS LLC
2022-11-30Z-0299-2023Class IIregard MAJOR CRANIROi CPS LLC
2022-11-30Z-0300-2023Class IIregard RETINAL PACKROi CPS LLC
2022-11-30Z-0301-2023Class IIregard VITRECTOMY PKROi CPS LLC
2022-11-30Z-0302-2023Class IIregard SPINEROi CPS LLC
2022-11-30Z-0303-2023Class II¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONYROi CPS LLC
2022-11-30Z-0304-2023Class IIregard TOTAL HIP ARTHROPLASTY A&BROi CPS LLC
2022-11-30Z-0305-2023Class II¿regard SHOULDER ARTHROSCOPYROi CPS LLC
2022-11-30Z-0306-2023Class II¿regard EYE TRAYROi CPS LLC
2022-11-30Z-0307-2023Class IIregard FOOT PACKROi CPS LLC
2022-11-30Z-0308-2023Class II¿regard SHOULDER PKROi CPS LLC
2022-11-30Z-0309-2023Class IIregard SHOULDER PACKROi CPS LLC
2022-11-30Z-0310-2023Class IIregard DAVINCI PACKROi CPS LLC
2022-11-30Z-0311-2023Class IIregard MINOR NEUROROi CPS LLC
2022-11-30Z-0312-2023Class IIregard NEURO TRAYROi CPS LLC
2022-11-30Z-0313-2023Class IIregard SPINE PACKROi CPS LLC
2022-11-30Z-0314-2023Class IIregard MINOR DAVINCI PACKROi CPS LLC
2022-11-30Z-0315-2023Class IIregard CATARACTROi CPS LLC
2022-11-30Z-0316-2023Class IIregard CATARACTROi CPS LLC
2022-11-30Z-0317-2023Class IIregard PEDIATRIC UROLOGYROi CPS LLC
2022-11-30Z-0318-2023Class IIregard SHOULDERROi CPS LLC
2022-11-30Z-0319-2023Class IIregard LATERAL SHOULDERROi CPS LLC
2022-11-30Z-0320-2023Class IIregard HIP ARTHROSCOPYROi CPS LLC
2022-11-30Z-0321-2023Class IIregard SPINEROi CPS LLC
2022-11-30Z-0322-2023Class IIregard SHOULDER ARTHROSCOPYROi CPS LLC
2022-11-23Z-0154-2023Class I18239: ASM Omnipod Dash PDMInsulet Corporation
2022-11-23Z-0200-2023Class IIEndo Stitch V-Loc 180 Absorbable ReloadCovidien, LP
2022-11-23Z-0201-2023Class IIEndo Stitch V-Loc PBT Non-Absorbable ReloadCovidien, LP
2022-11-23Z-0202-2023Class IIIMED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SETCanadian Hospital Specialties
2022-11-23Z-0203-2023Class IICareFusion VCarefusion 2200 Inc
2022-11-23Z-0204-2023Class IICareFusion VCarefusion 2200 Inc
2022-11-23Z-0205-2023Class IICareFusion VCarefusion 2200 Inc
2022-11-23Z-0206-2023Class IICareFusion VCarefusion 2200 Inc
2022-11-23Z-0207-2023Class IICareFusion VCarefusion 2200 Inc
2022-11-23Z-0208-2023Class IICareFusion VCarefusion 2200 Inc
2022-11-23Z-0209-2023Class IICareFusion VCarefusion 2200 Inc
2022-11-23Z-0210-2023Class IICareFusion VCarefusion 2200 Inc
2022-11-23Z-0211-2023Class IICareFusion VCarefusion 2200 Inc
2022-11-23Z-0212-2023Class IICareFusion VCarefusion 2200 Inc
2022-11-23Z-0213-2023Class IICareFusion VCarefusion 2200 Inc
2022-11-23Z-0214-2023Class IICareFusion VCarefusion 2200 Inc
2022-11-23Z-0215-2023Class IICareFusion VCarefusion 2200 Inc
2022-11-23Z-0216-2023Class IICareFusion VCarefusion 2200 Inc
2022-11-23Z-0217-2023Class IICareFusion VCarefusion 2200 Inc
2022-11-23Z-0218-2023Class IICareFusion VCarefusion 2200 Inc
2022-11-23Z-0219-2023Class IICareFusion VCarefusion 2200 Inc
2022-11-23Z-0221-2023Class IIPhilips Laser SystemSpectranetics Corporation
2022-11-23Z-0227-2023Class IITeleflex Medical RUSCH Pocket Pac iTELEFLEX LLC
2022-11-23Z-0228-2023Class IITufTex Embolectomy CatheterLeMaitre Vascular, Inc.
2022-11-23Z-0229-2023Class II125 series iGO2 Portable Oxygen Concentrator-indicated for the…DeVilbiss Healthcare LLC
2022-11-23Z-0230-2023Class IISuperion¿ Indirect Decompression SystemBoston Scientific Neuromodulation Corporation
2022-11-23Z-0231-2023Class IIHill-Rom Progressa Bed SystemBaxter Healthcare Corporation
2022-11-23Z-0232-2023Class IIBD Phoenix PMIC/ID-107: The Phoenix PMIC/ID panel is used for the…Becton Dickinson & Co.
2022-11-23Z-0233-2023Class IIGentleWave System APM Procedure Instrument with Matrix REF GW-APM-PI02Sonendo Inc
2022-11-23Z-0234-2023Class IIGentleWave System Posterior CleanFlow Procedure Instrument with…Sonendo Inc
2022-11-23Z-0235-2023Class IIAtrium Ocean Wet Suction Water Seal Chest Drain- Product Code:…Atrium Medical Corporation
2022-11-23Z-0239-2023Class IIExtension Tabletop for Operating Table System 1140Getinge Usa Sales Inc
2022-11-23Z-0240-2023Class IISimplex HV With Gentamicin CEHowmedica Osteonics Corp.
2022-11-23Z-0241-2023Class IIGI4000 Electrosurgical UnitSteris Corporation
2022-11-23Z-0242-2023Class IIDisposable Surgical Level 3 GownTexas Medical Technology Inc.
2022-11-23Z-0243-2023Class IIEasyStand BantamAltimate Medical, Inc.
2022-11-23Z-0244-2023Class IIVisualase Cooled Laser Applicator SystemMedtronic Navigation, Inc.
2022-11-23Z-0245-2023Class IIInfection ControlTollos
2022-11-23Z-0246-2023Class IIOneLIF Torque Limiting AdapterNovapproach Spine LLC
2022-11-16Z-0181-2023Class IINaturaLyte Liquid Acid concentrateFresenius Medical Care Holdings, Inc.
2022-11-16Z-0182-2023Class IISedecal Soltus Battery Mobile X-Ray System REF Soltus 450 Battery…SEDECAL SA
2022-11-16Z-0183-2023Class IIZio AT Clinical Reference ManualiRhythm Technologies, Inc.
2022-11-16Z-0184-2023Class IIFERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183…Ferno-Washington Inc
2022-11-16Z-0185-2023Class IICardinal Health GEL PACK REUSABLECardinal Health 200, LLC
2022-11-16Z-0186-2023Class IICardinal Health GEL PACK REUSABLECardinal Health 200, LLC
2022-11-16Z-0187-2023Class IICardinal Health HOT AND COLD GEL PACK REUSABLECardinal Health 200, LLC
2022-11-16Z-0188-2023Class IICardinal Health INSULATED GEL PACK REUSABLECardinal Health 200, LLC
2022-11-16Z-0189-2023Class IICardinal Health INSULATED GEL PACK REUSABLECardinal Health 200, LLC
2022-11-16Z-0190-2023Class IICardinal Health INSULATED GEL PACK REUSABLECardinal Health 200, LLC
2022-11-16Z-0191-2023Class IICardinal Health INSULATED GEL PACK REUSABLECardinal Health 200, LLC
2022-11-16Z-0192-2023Class IICardinal Health Reusable Gel PackCardinal Health 200, LLC
2022-11-16Z-0193-2023Class IIInsulin Pump/Model: MiniMed 630G/ MMT-1715Medtronic MiniMed
2022-11-16Z-0194-2023Class IIInsulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711Medtronic MiniMed
2022-11-16Z-0195-2023Class IIY-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2…Avanos Medical, Inc.
2022-11-16Z-0196-2023Class IIDisc Preparation instruments contained in the following products:…Alphatec Spine, Inc.
2022-11-16Z-0197-2023Class IIBeaver Arthro-Lok Pointed Tip Curve L 4mm Blade-an orthopedic bladeBeaver Visitec International, Inc.
2022-11-16Z-0198-2023Class IICanon Aplio ultrasound systemCanon Medical System, USA, INC.
2022-11-16Z-0199-2023Class IIScalpel and StatLock included with HydroPICC Catheter KitAccess Vascular, Inc.
2022-11-16Z-0220-2023Class IIVITROS Chemistry Products Calibrator Kit 9 -Ortho-Clinical Diagnostics, Inc.
2022-11-16Z-0222-2023Class IIX-Guide X-Mark Probe Tool -used for registering edentulous patients…X-NAV Technologies, LLC
2022-11-16Z-0223-2023Class IINEO-fit Neonatal Endotracheal Tube GripCooperSurgical, Inc.
2022-11-16Z-0224-2023Class IIORISE Gel Submucosal Lifting Agent--Indicated for use in…Boston Scientific Corporation
2022-11-16Z-0225-2023Class IIORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in…Boston Scientific Corporation
2022-11-16Z-0226-2023Class IIORISE ProKnife Procedure Kits: indicated for use in gastrointestinal…Boston Scientific Corporation
2022-11-09Z-0141-2023Class IHillrom Centrella Hospital Bed with WatchCare Incontinence Management…Baxter Healthcare Corporation
2022-11-09Z-0142-2023Class IHillrom Hospital Bed AccessoryBaxter Healthcare Corporation
2022-11-09Z-0143-2023Class IHillrom Hospital Bed AccessoryBaxter Healthcare Corporation
2022-11-09Z-0144-2023Class IHillrom Hospital Bed AccessoryBaxter Healthcare Corporation
2022-11-09Z-0145-2023Class IHillrom Hospital Bed AccessoryBaxter Healthcare Corporation
2022-11-09Z-0146-2023Class IIFogarty Arterial Embolectomy Catheters Model Number: 120602FP…Edwards Lifesciences, LLC
2022-11-09Z-0147-2023Class IIFogarty Biliary Balloon Probes Model Number: 410235FP 410405FP…Edwards Lifesciences, LLC
2022-11-09Z-0148-2023Class IIsentec 24 / MARe-SF Multi-Site Attachment Ring EasySenTec AG
2022-11-09Z-0149-2023Class IIEKOS Control Unit 4Boston Scientific Corporation
2022-11-09Z-0150-2023Class IISTRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0Ethicon, Inc.
2022-11-09Z-0151-2023Class IIEMBLEM S-ICDBoston Scientific Corporation
2022-11-09Z-0152-2023Class IIEMBLEM MRI S-ICDBoston Scientific Corporation
2022-11-09Z-0153-2023Class IICritiCoolBelmont Instrument Corporation
2022-11-09Z-0155-2023Class IIBAUSCH + LOMB EYE PACKMEDLINE INDUSTRIES, LP - Northfield
2022-11-09Z-0156-2023Class IIBAUSCH + LOMB PHACO PACKMEDLINE INDUSTRIES, LP - Northfield
2022-11-09Z-0157-2023Class IIBAUSCH + LOMB BASIC OPHTHALMIC PACKMEDLINE INDUSTRIES, LP - Northfield

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