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Medical device recalls reported in 2024

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ReportedRecallClassProductFirm
2024-12-04Z-0572-2025Class IITriALTIS TORQUE LIMITERGauthier Biomedical, Inc.
2024-12-04Z-0580-2025Class IIMICRO-X Rover Mobile X-ray SystemMicro-X Ltd.
2024-11-27Z-0373-2025Class IBaxter MiniCap Extended Life PD Transfer Set with Twist ClampBaxter Healthcare Corporation
2024-11-27Z-0374-2025Class IBaxter MiniCap Extended Life PD Transfer Set with Twist ClampBaxter Healthcare Corporation
2024-11-27Z-0375-2025Class IBaxter MiniCap Extended Life PD Transfer Set with Twist ClampBaxter Healthcare Corporation
2024-11-27Z-0376-2025Class IBaxter MiniCap Extended Life PD Transfer Set with Twist ClampBaxter Healthcare Corporation
2024-11-27Z-0377-2025Class IBaxter MiniCap Extended Life PD Transfer Set with Twist ClampBaxter Healthcare Corporation
2024-11-27Z-0378-2025Class IBaxter MiniCap Extended Life PD Transfer Set with Twist ClampBaxter Healthcare Corporation
2024-11-27Z-0379-2025Class IBaxter MiniCap Extended Life PD Transfer Set with Twist ClampBaxter Healthcare Corporation
2024-11-27Z-0380-2025Class IBaxter MiniCap Extended Life PD Transfer Set with Twist ClampBaxter Healthcare Corporation
2024-11-27Z-0381-2025Class IBaxter MiniCap Extended Life PD Transfer Set with Twist ClampBaxter Healthcare Corporation
2024-11-27Z-0382-2025Class IBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX ShortBaxter Healthcare Corporation
2024-11-27Z-0466-2025Class IIsmiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapterSmiths Medical ASD, Inc.
2024-11-27Z-0467-2025Class IIBard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT…Bard Peripheral Vascular Inc
2024-11-27Z-0468-2025Class IIPosi-Stop Injection NeedleHobbs Medical, Inc.
2024-11-27Z-0469-2025Class IIPosi-Stop Injection NeedleHobbs Medical, Inc.
2024-11-27Z-0470-2025Class IIPosi-Stop Injection NeedleHobbs Medical, Inc.
2024-11-27Z-0471-2025Class IIPosi-Stop Injection NeedleHobbs Medical, Inc.
2024-11-27Z-0472-2025Class IIPosi-Stop Injection NeedleHobbs Medical, Inc.
2024-11-27Z-0473-2025Class IIPosi-Stop Injection NeedleHobbs Medical, Inc.
2024-11-27Z-0474-2025Class IIPosi-Stop Injection NeedleHobbs Medical, Inc.
2024-11-27Z-0475-2025Class IIPosi-Stop Injection NeedleHobbs Medical, Inc.
2024-11-27Z-0476-2025Class IIPosi-Stop Injection NeedleHobbs Medical, Inc.
2024-11-27Z-0477-2025Class IIJuggerLoc/ToggleLoc 2Biomet, Inc.
2024-11-27Z-0478-2025Class IICAIRE FreeStyle Comfort portable oxygen concentratorCaire, Inc.
2024-11-27Z-0479-2025Class IICAIRE FreeStyle Comfort portable oxygen concentratorCaire, Inc.
2024-11-27Z-0480-2025Class IICAIRE FreeStyle Comfort portable oxygen concentratorCaire, Inc.
2024-11-27Z-0481-2025Class IICAIRE FreeStyle Comfort portable oxygen concentratorCaire, Inc.
2024-11-27Z-0482-2025Class IAllegedly counterfeit batteries manufactured by CSB batteries being…ICU Medical, Inc.
2024-11-27Z-0483-2025Class IINovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip SystemNovosource, LLC
2024-11-27Z-0484-2025Class IIAcrobat-i PositionerMaquet Cardiovascular, LLC
2024-11-27Z-0485-2025Class IIAcrobat SUV Vacuum Stabilizer SystemMaquet Cardiovascular, LLC
2024-11-27Z-0486-2025Class IIAcrobat-i Vacuum Stabilizer SystemMaquet Cardiovascular, LLC
2024-11-27Z-0487-2025Class IIMONOCRYL"ETHICON, INC.
2024-11-27Z-0488-2025Class IIEnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1…Enchroma Inc
2024-11-27Z-0489-2025Class IIcobas HCYSRoche Diagnostics Operations, Inc.
2024-11-27Z-0490-2025Class IIIa) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERVAlcon Research LLC
2024-11-27Z-0491-2025Class IIAbbott Navitor TitanAbbott Medical
2024-11-27Z-0492-2025Class IIAbbott Navitor Transcatheter Aortic Heart ValveAbbott Medical
2024-11-27Z-0493-2025Class IIAbbot NavitorAbbott Medical
2024-11-27Z-0494-2025Class IIAbbott NavitorAbbott Medical
2024-11-27Z-0495-2025Class IIAbbott Navitor Transcatheter Aortic Heart ValveAbbott Medical
2024-11-27Z-0496-2025Class IISiemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that…Siemens Healthcare Diagnostics, Inc.
2024-11-27Z-0497-2025Class IIVue PACS Diagnostic Viewer with Vue PACS client 12Philips Medical Systems Technologies Ltd.
2024-11-27Z-0498-2025Class IIBrand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190…Olympus Corporation of the Americas
2024-11-27Z-0499-2025Class IIApproach CTO Micro Wire GuideCook Incorporated
2024-11-27Z-0500-2025Class IIPrecice Max REF: PM10NuVasive Specialized Orthopedics, Inc.
2024-11-27Z-0501-2025Class IIOrganOx metra -Intended as a Normothermic Machine Perfusion system of…OrganOx Ltd
2024-11-27Z-0506-2025Class IIZ-800 Infusion SystemZyno Medical LLC
2024-11-20Z-0290-2025Class ITrilogy Evo O2Philips Respironics, Inc.
2024-11-20Z-0291-2025Class ITrilogy EvoPhilips Respironics, Inc.
2024-11-20Z-0292-2025Class ITrilogy Evo Universal VentilatorPhilips Respironics, Inc.
2024-11-20Z-0293-2025Class ITrilogy EV300Philips Respironics, Inc.
2024-11-20Z-0294-2025Class IAeris EVOPhilips Respironics, Inc.
2024-11-20Z-0295-2025Class IGarbin EvoPhilips Respironics, Inc.
2024-11-20Z-0296-2025Class ILifeVent EVO2Philips Respironics, Inc.
2024-11-20Z-0297-2025Class IBoston Scientific POLARx BALLOON CATHETER ST 28MM OUSBoston Scientific Corporation
2024-11-20Z-0298-2025Class IBoston Scientific POLARx BALLOON CATHETER LT 28MM OUSBoston Scientific Corporation
2024-11-20Z-0299-2025Class IBoston Scientific POLARx FIT BALLOON CATHETER ST OUSBoston Scientific Corporation
2024-11-20Z-0300-2025Class IBoston Scientific POLARx FIT BALLOON CATHETER ST USBoston Scientific Corporation
2024-11-20Z-0301-2025Class IBoston Scientific POLARx FIT BALLOON CATHETER LT OUSBoston Scientific Corporation
2024-11-20Z-0302-2025Class IBoston Scientific POLARx FIT BALLOON CATHETER LT USBoston Scientific Corporation
2024-11-20Z-0303-2025Class IBoston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number…Boston Scientific Corporation
2024-11-20Z-0304-2025Class IBrand Name: Atlan Product Name: Atlan A350 Model/Catalog Number:…Draeger Medical, Inc.
2024-11-20Z-0305-2025Class IBrand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number:…Draeger Medical, Inc.
2024-11-20Z-0310-2025Class IMonoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft PackCardinal Health 200, LLC
2024-11-20Z-0312-2025Class ImicroTargeting Insertion Tube SetFHC, Inc.
2024-11-20Z-0327-2025Class IBaxter AK 98 Dialysis MachineBaxter Healthcare Corporation
2024-11-20Z-0329-2025Class IISafeControl handsetWISSNER-BOSSERHOFF GMBH
2024-11-20Z-0330-2025Class IIVYGON 100 mL EMPTY EVA CONTAINER With 2 PortsThe Metrix Company
2024-11-20Z-0331-2025Class IIVYGON 250 mL EMPTY EVA CONTAINER With 2 PortsThe Metrix Company
2024-11-20Z-0332-2025Class IICORMIX 150 mL EMPTY EVA CONTAINER With 2 PortsThe Metrix Company
2024-11-20Z-0333-2025Class IICORMIX 250 mL EMPTY EVA CONTAINER With 2 PortsThe Metrix Company
2024-11-20Z-0334-2025Class IICORMIX 500 mL EMPTY EVA CONTAINER With 2 PortsThe Metrix Company
2024-11-20Z-0335-2025Class IISECURE 100 mL EMPTY EVA CONTAINER With 2 PortsThe Metrix Company
2024-11-20Z-0336-2025Class IISECURE 100 mL EMPTY EVA CONTAINER With 2 PortsThe Metrix Company
2024-11-20Z-0337-2025Class IISECURE 50 mL EMPTY EVA CONTAINER With 2 PortsThe Metrix Company
2024-11-20Z-0338-2025Class IISECURE 50 mL EMPTY EVA CONTAINER With 2 PortsThe Metrix Company
2024-11-20Z-0339-2025Class IISECURE 250 mL EMPTY EVA CONTAINER With 2 PortsThe Metrix Company
2024-11-20Z-0340-2025Class IISECURE 500 mL EMPTY EVA CONTAINER With 2 PortsThe Metrix Company
2024-11-20Z-0341-2025Class IISECURE 1000 mL EMPTY EVA CONTAINER With 2 PortsThe Metrix Company
2024-11-20Z-0342-2025Class IIImed Products Imed EVA BAGThe Metrix Company
2024-11-20Z-0343-2025Class IIImed Products Imed EVA BAGThe Metrix Company
2024-11-20Z-0344-2025Class IIImed Products Imed EVA BAGThe Metrix Company
2024-11-20Z-0345-2025Class IIImed Products Imed EVA BAGThe Metrix Company
2024-11-20Z-0346-2025Class IIApproach CTO Micro Wire GuideCook Incorporated
2024-11-20Z-0347-2025Class IIApproach Hydro ST Micro Wire GuideCook Incorporated
2024-11-20Z-0348-2025Class IIBaxter Spectrum IQ Infusion System with Dose IQ Safety SoftwareBaxter Healthcare Corporation
2024-11-20Z-0349-2025Class IICARROLLTON HIP FX Convenience kit used for surgical proceduresMEDLINE INDUSTRIES, LP - Northfield
2024-11-20Z-0350-2025Class IIARTHROSCOPY Convenience kit used for surgical proceduresMEDLINE INDUSTRIES, LP - Northfield
2024-11-20Z-0351-2025Class IIBrand Name: Olympus Product Name: Cystoscope Outer Sheath…Olympus Corporation of the Americas
2024-11-20Z-0352-2025Class IIPhilips Zenition 50PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2024-11-20Z-0353-2025Class IIPhilips Zenition 70PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
2024-11-20Z-0354-2025Class IIClean Catch KitMEDLINE INDUSTRIES, LP - Northfield
2024-11-20Z-0355-2025Class IILab KitMEDLINE INDUSTRIES, LP - Northfield
2024-11-20Z-0356-2025Class IIUA KITMEDLINE INDUSTRIES, LP - Northfield
2024-11-20Z-0357-2025Class IIURINALYSIS KIT 4MEDLINE INDUSTRIES, LP - Northfield
2024-11-20Z-0358-2025Class IIURINE COLLECTION KITMEDLINE INDUSTRIES, LP - Northfield
2024-11-20Z-0359-2025Class IIURINE COLLECTION VHCMEDLINE INDUSTRIES, LP - Northfield
2024-11-20Z-0360-2025Class IIURINE KITMEDLINE INDUSTRIES, LP - Northfield
2024-11-20Z-0361-2025Class IIURINE KIT W/BD CUPMEDLINE INDUSTRIES, LP - Northfield
2024-11-20Z-0362-2025Class IIThe IMAGEnet 6 Ophthalmic Data System is a software program that is…Topcon Medical Systems, Inc.
2024-11-20Z-0363-2025Class IIIrrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10…Karl Storz Endoscopy
2024-11-20Z-0364-2025Class IIBrand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral…Olympus Corporation of the Americas
2024-11-20Z-0365-2025Class IIStryker Neptune SafeAir Rocker-Switch Smoke Evacuation PencilStryker Corporation
2024-11-20Z-0366-2025Class IIStryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-SwitchStryker Corporation
2024-11-20Z-0367-2025Class IIStryker Neptune SafeAir Rocker-Switch Smoke Evacuation PencilStryker Corporation
2024-11-20Z-0368-2025Class IIStryker Neptune SafeAir Smoke Evacuation PencilStryker Corporation
2024-11-20Z-0369-2025Class IIStryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm…Stryker Corporation
2024-11-20Z-0370-2025Class IIStryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-ButtonStryker Corporation
2024-11-20Z-0371-2025Class IIThe EVSRF catheter is a sterileBard Peripheral Vascular Inc
2024-11-20Z-0372-2025Class IIMedtronic Recharger KitsMedtronic Neuromodulation
2024-11-20Z-0383-2025Class IIHalyard IR ABCESS DRAINAGE PACKAVID Medical, Inc.
2024-11-20Z-0384-2025Class IIHalyard IR BIOPSY PACKAVID Medical, Inc.
2024-11-20Z-0385-2025Class IIHalyard D & C PACK-CKCAVID Medical, Inc.
2024-11-20Z-0386-2025Class IIHalyard ENT T AND A PACKAVID Medical, Inc.
2024-11-20Z-0387-2025Class IIHalyard OPEN HEART PACK MAINAVID Medical, Inc.
2024-11-20Z-0388-2025Class IIHalyard AORTA PACKAVID Medical, Inc.
2024-11-20Z-0389-2025Class IIHalyard GENERAL SET UP PACKAVID Medical, Inc.
2024-11-20Z-0390-2025Class IIHalyard KITAVID Medical, Inc.
2024-11-20Z-0391-2025Class IIHalyard KITAVID Medical, Inc.
2024-11-20Z-0392-2025Class IIHalyard KITAVID Medical, Inc.
2024-11-20Z-0393-2025Class IIHalyard ANTERIOR HIP PACKAVID Medical, Inc.
2024-11-20Z-0394-2025Class IIHalyard KITAVID Medical, Inc.
2024-11-20Z-0395-2025Class IIHalyard KITAVID Medical, Inc.
2024-11-20Z-0396-2025Class IIHalyard KITAVID Medical, Inc.
2024-11-20Z-0397-2025Class IIHalyard KITAVID Medical, Inc.
2024-11-20Z-0398-2025Class IIHalyard FOOT ANKLE PACKAVID Medical, Inc.
2024-11-20Z-0399-2025Class IIHalyard ABDOMINAL PROCEDUREAVID Medical, Inc.
2024-11-20Z-0400-2025Class IIHalyard BASIC PROCEDURE PACKAVID Medical, Inc.
2024-11-20Z-0401-2025Class IIHalyard TOTAL KNEEAVID Medical, Inc.
2024-11-20Z-0402-2025Class IIHalyard CYSTO PDSAVID Medical, Inc.
2024-11-20Z-0403-2025Class IIHalyard MINOR PDSAVID Medical, Inc.
2024-11-20Z-0404-2025Class IIHalyard LAPAROSCOPY TRAYAVID Medical, Inc.
2024-11-20Z-0405-2025Class IIHalyard GYN TRAYAVID Medical, Inc.
2024-11-20Z-0406-2025Class IIHalyard C SECTION BUNDLEAVID Medical, Inc.
2024-11-20Z-0407-2025Class IIHalyard VAG HYSTERECTOMY BUNDLE PKAVID Medical, Inc.
2024-11-20Z-0408-2025Class IIHalyard POST PARTUM TUBAL LIGATIONAVID Medical, Inc.
2024-11-20Z-0409-2025Class IIHalyard TAH-BUNDLEAVID Medical, Inc.
2024-11-20Z-0410-2025Class IIHalyard KNEE ARTHROSCOPY PACKAVID Medical, Inc.
2024-11-20Z-0411-2025Class IIHalyard LINE INSERTION PACKAVID Medical, Inc.
2024-11-20Z-0412-2025Class IIHalyard ANGIOGRAPHY PACKAVID Medical, Inc.
2024-11-20Z-0413-2025Class IIHalyard PACEMAKER PACKAVID Medical, Inc.
2024-11-20Z-0414-2025Class IIHalyard ANGIO ARTERIOGRAM PACKAVID Medical, Inc.
2024-11-20Z-0415-2025Class IIHalyard ORTHO PACK -Medical convenience kits Model Number: MMOK006-04AVID Medical, Inc.
2024-11-20Z-0416-2025Class IIHalyard EXTREMITY PACKAVID Medical, Inc.
2024-11-20Z-0417-2025Class IIHalyard MINOR PACKAVID Medical, Inc.
2024-11-20Z-0418-2025Class IIHalyard HEART CATH LAB PKAVID Medical, Inc.
2024-11-20Z-0419-2025Class IIHalyard LOWER EXTREMITY PACKAVID Medical, Inc.
2024-11-20Z-0420-2025Class IIHalyard UPPER EXTREMITY PACKAVID Medical, Inc.
2024-11-20Z-0421-2025Class IIHalyard SHOULDER PACKAVID Medical, Inc.
2024-11-20Z-0422-2025Class IIHalyard INTERVENTIONAL TRAYAVID Medical, Inc.
2024-11-20Z-0423-2025Class IIHalyard LAPAROTOMY GYN PACKAVID Medical, Inc.
2024-11-20Z-0424-2025Class IIHalyard MAJOR VAGINAL GYN PACKAVID Medical, Inc.
2024-11-20Z-0425-2025Class IIHalyard UROLOGY LAPAROTOMY PACKAVID Medical, Inc.
2024-11-20Z-0426-2025Class IIHalyard ORAL SURGERY HEADAVID Medical, Inc.
2024-11-20Z-0427-2025Class IIHalyard OR ENDOVASCULAR TRAYAVID Medical, Inc.
2024-11-20Z-0428-2025Class IIHalyard EYE PLASTIC TRAYAVID Medical, Inc.
2024-11-20Z-0429-2025Class IIHalyard SAMMC-N PACEMAKERAVID Medical, Inc.
2024-11-20Z-0430-2025Class IIHalyard SAMMC ANGIOGRAPHYAVID Medical, Inc.
2024-11-20Z-0431-2025Class IIHalyard CPT CARDIAC CATH PACKAVID Medical, Inc.
2024-11-20Z-0432-2025Class IIHalyard CPT PEDS ADULT CH PACKAVID Medical, Inc.
2024-11-20Z-0433-2025Class IIHalyard CPT PEDS ADULT CH PACKAVID Medical, Inc.
2024-11-20Z-0434-2025Class IIHalyard CPT EP PACKAVID Medical, Inc.
2024-11-20Z-0435-2025Class IIHalyard C SECTION PACKAVID Medical, Inc.
2024-11-20Z-0436-2025Class IIHalyard GYN PACAVID Medical, Inc.
2024-11-20Z-0437-2025Class IIHalyard CATH LAB PACKAVID Medical, Inc.
2024-11-20Z-0438-2025Class IIHalyard RAD PACKAVID Medical, Inc.
2024-11-20Z-0439-2025Class IIHalyard EP PACKAVID Medical, Inc.
2024-11-20Z-0440-2025Class IIHalyard BIOPSY PACKAVID Medical, Inc.
2024-11-20Z-0441-2025Class IIHalyard ANGIO TRAYAVID Medical, Inc.
2024-11-20Z-0442-2025Class IIHalyard PACEMAKER INSTRUMENT PACKAVID Medical, Inc.
2024-11-20Z-0443-2025Class IIHalyard PACEMAKER DRAPEAVID Medical, Inc.
2024-11-20Z-0444-2025Class IIHalyard IVR VASCULAR PACKAVID Medical, Inc.
2024-11-20Z-0445-2025Class IIHalyard SPECIALS PACKAVID Medical, Inc.
2024-11-20Z-0446-2025Class IIHalyard EP TRAYAVID Medical, Inc.
2024-11-20Z-0447-2025Class IIHalyard ANGIOGRAPHY DRAPE PACKAVID Medical, Inc.
2024-11-20Z-0448-2025Class IIHalyard MANIFOLD CATH PACKAVID Medical, Inc.
2024-11-20Z-0449-2025Class IIHalyard ENDOVASCULARAVID Medical, Inc.
2024-11-20Z-0450-2025Class IIHalyard VA LUMBAR LAMINECTOMYAVID Medical, Inc.
2024-11-20Z-0451-2025Class IIHalyard ENTAVID Medical, Inc.
2024-11-20Z-0452-2025Class IIHalyard PACKAVID Medical, Inc.
2024-11-20Z-0453-2025Class IIHalyard PACEMAKER TRAYAVID Medical, Inc.
2024-11-20Z-0454-2025Class IIHalyard PACEMAKER PKAVID Medical, Inc.
2024-11-20Z-0455-2025Class IIHalyard ANGIO PACKAVID Medical, Inc.
2024-11-20Z-0456-2025Class IIMEERA CL mobile operating tableGetinge Usa Sales Inc
2024-11-20Z-0457-2025Class IIMEERA CL mobile operating tableGetinge Usa Sales Inc
2024-11-20Z-0458-2025Class IIMEERA CL mobile operating tableGetinge Usa Sales Inc
2024-11-20Z-0459-2025Class IIMEERA CL mobile operating tableGetinge Usa Sales Inc
2024-11-20Z-0460-2025Class IIMEERA CL mobile operating tableGetinge Usa Sales Inc
2024-11-20Z-0461-2025Class IIMEERA CL mobile operating tableGetinge Usa Sales Inc
2024-11-20Z-0462-2025Class IIMEERA CL mobile operating tableGetinge Usa Sales Inc
2024-11-20Z-0463-2025Class IIMEERA CL mobile operating tableGetinge Usa Sales Inc
2024-11-20Z-0464-2025Class IIIMMULITE 2000 PSA assaySiemens Healthcare Diagnostics, Inc.
2024-11-20Z-0465-2025Class IIMedline Iris ScissorsMEDLINE INDUSTRIES, LP - Northfield
2024-11-13Z-0227-2025Class IElekta Disposable Biopsy Needle Kit for Leksell Stereotactic SystemElekta Instrument AB
2024-11-13Z-0284-2025Class IICartesion PrimeCanon Medical System, USA, INC.
2024-11-13Z-0285-2025Class IISaphena Medical Venapax XL- Endoscopic Vessel Harvesting System for…Zimmer, Inc.
2024-11-13Z-0286-2025Class IIepoc BGEM BUN Test CardSiemens Healthcare Diagnostics Inc
2024-11-13Z-0287-2025Class IIAmericot 20-01SAmerican Surgical Company, LLC

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