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Medical device recalls reported in 2025

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ReportedRecallClassProductFirm
2025-09-03Z-2379-2025Class IIIL17-5 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2380-2025Class IIIL18-5 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2381-2025Class IIIL8-4 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2382-2025Class IIIL9-3 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2383-2025Class IIImC12-3 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2384-2025Class IIImC7-2 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2385-2025Class IIIMini Multi TEE Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2386-2025Class IIImL26-8 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2387-2025Class IIIOMNI II TEE Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2388-2025Class IIIOMNI III TEE Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2389-2025Class IIIS12-4 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2390-2025Class IIIS3-1 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2391-2025Class IIIS4-1 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2392-2025Class IIIS4-1 Lumify Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2393-2025Class IIIS4-2 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2394-2025Class IIIS5-2 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2395-2025Class IIIS7-3t Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2396-2025Class IIIS7-2t Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2397-2025Class IIIS8-3 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2398-2025Class IIIS8-3t Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2399-2025Class IIIS9-2 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2400-2025Class IIISCNHD LA L7-4 HDI Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2401-2025Class IIITransducer C10-3v Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2402-2025Class IIITRANSDUCER L12-5 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2403-2025Class IIIV6-2 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2404-2025Class IIIV9-2 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2405-2025Class IIIVL13-5 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2406-2025Class IIIX11-4t Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2407-2025Class IIIX3-1 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2408-2025Class IIIX5-1 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2409-2025Class IIIX5-1c Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2410-2025Class IIIX6-1 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2411-2025Class IIIX7-2 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2412-2025Class IIIX7-2t Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2413-2025Class IIIX8-2t Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2414-2025Class IIIXL14-3 Transducer ProbePhilips Ultrasound, Inc
2025-09-03Z-2415-2025Class IISpectrum IQ Infusion PumpBaxter Healthcare Corporation
2025-09-03Z-2416-2025Class IIBrand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188…THOR Photomedicine Ltd
2025-09-03Z-2417-2025Class IIBrand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number:…THOR Photomedicine Ltd
2025-09-03Z-2418-2025Class IIBrand Name: THOR Product Name: NovoTHOR Gen 3THOR Photomedicine Ltd
2025-09-03Z-2419-2025Class IIBrand Name: THOR Product Name: NovoTHOR Gen 3THOR Photomedicine Ltd
2025-09-03Z-2420-2025Class IICorin Operating Tables Model Numbers:MAQUET GMBH
2025-09-03Z-2421-2025Class IIBrand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit…Dentsply IH, Inc.
2025-09-03Z-2422-2025Class IIBrand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit…Dentsply IH, Inc.
2025-09-03Z-2423-2025Class IIELEOS SEGMENTAL LIMB SALVAGE SYSTEMOnkos Surgical, Inc.
2025-09-03Z-2424-2025Class IIELEOS SEGMENTAL LIMB SALVAGE SYSTEMOnkos Surgical, Inc.
2025-09-03Z-2425-2025Class IIELEOS SEGMENTAL LIMB SALVAGE SYSTEMOnkos Surgical, Inc.
2025-09-03Z-2437-2025Class IIPrisMax V2-USVANTIVE US HEALTHCARE LLC
2025-09-03Z-2438-2025Class IIPrisMax V3 control Unit-USVANTIVE US HEALTHCARE LLC
2025-09-03Z-2439-2025Class IITherMax Blood Warmer Unit-USVANTIVE US HEALTHCARE LLC
2025-09-03Z-2440-2025Class IIOrascoptic Superior Visualization Custom loupes with Dragonfly framesOrascoptic Surgical Acuity
2025-09-03Z-2441-2025Class IIOrascoptic Superior Visualization Custom loupes configured with…Orascoptic Surgical Acuity
2025-09-03Z-2442-2025Class IIOrascoptic Superior Visualization Dragonfly Essentials KitOrascoptic Surgical Acuity
2025-09-03Z-2443-2025Class IIOrascoptic Superior Visualization Phantom Essential kitOrascoptic Surgical Acuity
2025-09-03Z-2444-2025Class IIOrascoptic Superior Visualization Dragonfly Nose Pad Accessory KitOrascoptic Surgical Acuity
2025-09-03Z-2445-2025Class IIOrascoptic Superior Visualization Phantom Nose Pad Accessory KitOrascoptic Surgical Acuity
2025-09-03Z-2451-2025Class IIIAkreosBausch & Lomb Surgical, Inc.
2025-09-03Z-2452-2025Class IIThe Medline General Surgery Tray is customized to meet requirements…MEDLINE INDUSTRIES, LP - Northfield
2025-09-03Z-2453-2025Class IIBD PhaSeal Injector LuerBD SWITZERLAND SARL
2025-09-03Z-2460-2025Class IMedline ReNewal Reprocessed StMEDLINE INDUSTRIES, LP - Northfield
2025-09-03Z-2461-2025Class IIIPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834Medtronic Xomed, Inc.
2025-09-03Z-2462-2025Class IIBardex Lubri-Sil IC.R. Bard Inc
2025-09-03Z-2463-2025Class IIBrand Name: HOMEDICS Product Name: Air Compression Leg Massager…Zhejiang Luyao Electronics Technology Co., Ltd.
2025-09-03Z-2464-2025Class IIAMERICAN CONTRACT SYSTEMSAmerican Contract Systems Inc
2025-09-03Z-2465-2025Class IIAMERICAN CONTRACT SYSTEMSAmerican Contract Systems Inc
2025-09-03Z-2466-2025Class IIAMERICAN CONTRACT SYSTEMSAmerican Contract Systems Inc
2025-09-03Z-2467-2025Class IIAMERICAN CONTRACT SYSTEMSAmerican Contract Systems Inc
2025-09-03Z-2468-2025Class IIAMERICAN CONTRACT SYSTEMSAmerican Contract Systems Inc
2025-09-03Z-2469-2025Class IIAMERICAN CONTRACT SYSTEMSAmerican Contract Systems Inc
2025-09-03Z-2470-2025Class IIAMERICAN CONTRACT SYSTEMSAmerican Contract Systems Inc
2025-09-03Z-2471-2025Class IIAMERICAN CONTRACT SYSTEMSAmerican Contract Systems Inc
2025-09-03Z-2472-2025Class IIAMERICAN CONTRACT SYSTEMSAmerican Contract Systems Inc
2025-09-03Z-2473-2025Class IISTA SatelliteDiagnostica Stago, Inc.
2025-09-03Z-2474-2025Class IISTA-Liquid Anti-Xa 4Diagnostica Stago, Inc.
2025-09-03Z-2475-2025Class IISTA-Liquid Anti-Xa 8Diagnostica Stago, Inc.
2025-09-03Z-2476-2025Class IISTADiagnostica Stago, Inc.
2025-09-03Z-2477-2025Class IIBD Pyxis Product Name / UDI-DI code / Catalog NoCareFusion 303, Inc.
2025-09-03Z-2479-2025Class IIMedline Kits containing BD SureStep Foley Tray Systems:…MEDLINE INDUSTRIES, LP - Northfield
2025-08-27Z-2325-2025Class IENDOTAK RELIANCE G/SGBoston Scientific Corporation
2025-08-27Z-2326-2025Class IENDOTAK RELIANCE G/SG with 4-SITE ConnectorBoston Scientific Corporation
2025-08-27Z-2327-2025Class IRELIANCE 4-FRONTBoston Scientific Corporation
2025-08-27Z-2328-2025Class IHamilton C6 REF 160021Hamilton Medical AG
2025-08-27Z-2329-2025Class IIPentax Medical Video ProcessorPentax of America Inc
2025-08-27Z-2330-2025Class IIBrand Name: Q-Stop Product Name: Suture Retention Device…Drs Vascular, Inc
2025-08-27Z-2331-2025Class IIInjection needleSpiggle & Theis Mt Gmbh
2025-08-27Z-2335-2025Class IIVITROS Chemistry Products Ca SlidesOrtho-Clinical Diagnostics, Inc.
2025-08-27Z-2336-2025Class IIEstrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone…Immunotech A.S.
2025-08-27Z-2337-2025Class IIClearview Strep A Exact II Dipstick Respiratory KitMckesson Medical-Surgical Inc. Corporate Office
2025-08-27Z-2338-2025Class IIElectrosurgicalOlympus Corporation of the Americas
2025-08-27Z-2339-2025Class IIElectrosurgicalOlympus Corporation of the Americas
2025-08-27Z-2340-2025Class IIBurr Hole Cover KitBoston Scientific Neuromodulation Corporation
2025-08-27Z-2344-2025Class IIOtoLase Starter KitLUMENIS, LTD.
2025-08-27Z-2345-2025Class IIDynex Agility Sample TipsDynex Technologies, Inc.
2025-08-20Z-2173-2025Class IBaxter Novum IQ Large Volume PumpBaxter Healthcare Corporation
2025-08-20Z-2181-2025Class IAmbu SPUR II Labeled as the following: 1 SPUR II Adult ResuscitatorAmbu Inc.
2025-08-20Z-2227-2025Class IDreamStation Auto CPAPPhilips Respironics, Inc.
2025-08-20Z-2228-2025Class IDreamStation Auto BiPAPPhilips Respironics, Inc.
2025-08-20Z-2229-2025Class IDreamStation AutoPhilips Respironics, Inc.
2025-08-20Z-2273-2025Class ICarotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding…Boston Scientific Corporation
2025-08-20Z-2278-2025Class IIFARAWAVE 1Boston Scientific Corporation
2025-08-20Z-2279-2025Class IIBrand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED…SPINEART SA
2025-08-20Z-2280-2025Class IIBrand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED…SPINEART SA
2025-08-20Z-2281-2025Class IIBrand Name: Carefree Surgical Specialties Product Name:…Carefree Surgical Specialties
2025-08-20Z-2282-2025Class IIBrand Name: Carefree Surgical Specialties Product Name:…Carefree Surgical Specialties
2025-08-20Z-2283-2025Class IIBrand Name: Carefree Surgical Specialties Product Name:…Carefree Surgical Specialties
2025-08-20Z-2284-2025Class IIBrand Name: Carefree Surgical Specialties Product Name:…Carefree Surgical Specialties
2025-08-20Z-2285-2025Class IIBrand Name: EMPOWR 3D KNEE TIBIAL INSERTEncore Medical, LP
2025-08-20Z-2286-2025Class IIBrand Name: EMPOWR 3D KNEE TIBIAL INSERTEncore Medical, LP
2025-08-20Z-2287-2025Class IISparrow Ascent Patient ControllerSpark Biomedical Inc
2025-08-20Z-2288-2025Class IIProsthesis Head BWaldemar Link GmbH & Co. KG (Mfg Site)
2025-08-20Z-2289-2025Class IIPlastic Trial Head BrownWaldemar Link GmbH & Co. KG (Mfg Site)
2025-08-20Z-2290-2025Class IBrand Name: HeartMate Product Name: Mobile Power UnitThoratec LLC
2025-08-20Z-2291-2025Class IBrand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog…Thoratec LLC
2025-08-20Z-2292-2025Class IIBartels ELISA Legionella Urinary AntigenTrinity Biotech USA
2025-08-20Z-2293-2025Class IIHigh Pressure Tubing: REF: 502211002Merit Medical Systems, Inc.
2025-08-20Z-2294-2025Class IICustom Tubing Kit: REF: K04-00417Merit Medical Systems, Inc.
2025-08-20Z-2295-2025Class IICustom Manifold Kit: REF: K09-02239CMerit Medical Systems, Inc.
2025-08-20Z-2296-2025Class IICustom Waste Management Kit: REF: K10-00353KMerit Medical Systems, Inc.
2025-08-20Z-2297-2025Class II3mensio WorkstationPIE Medical Imaging B.V.
2025-08-20Z-2298-2025Class IIBrand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter…Insightra Medical Inc
2025-08-20Z-2299-2025Class IIGE Signa ArtistGE Medical Systems, LLC
2025-08-20Z-2300-2025Class IIGE Signa VoyagerGE Medical Systems, LLC
2025-08-20Z-2301-2025Class IIGE Discovery MR450 1GE Medical Systems, LLC
2025-08-20Z-2302-2025Class IIGE Optima MR450w 1GE Medical Systems, LLC
2025-08-20Z-2303-2025Class IIGE SIGNA ArchitectGE Medical Systems, LLC
2025-08-20Z-2304-2025Class IIGE SIGNA PremierGE Medical Systems, LLC
2025-08-20Z-2305-2025Class IIGE SIGNA UHPGE Medical Systems, LLC
2025-08-20Z-2306-2025Class IIGE Discovery MR750 3GE Medical Systems, LLC
2025-08-20Z-2307-2025Class IIGE Discovery MR750w 3GE Medical Systems, LLC
2025-08-20Z-2308-2025Class IIGE SIGNA HeroGE Medical Systems, LLC
2025-08-20Z-2309-2025Class IIGE SIGNA PET/MRGE Medical Systems, LLC
2025-08-20Z-2310-2025Class IIGE SIGNA Artist EvoGE Medical Systems, LLC
2025-08-20Z-2311-2025Class IIGE SIGNA Voyager AIRGE Medical Systems, LLC
2025-08-20Z-2312-2025Class IIGE SIGNA Architect AIRGE Medical Systems, LLC
2025-08-20Z-2313-2025Class IIGE SIGNA Premier XTGE Medical Systems, LLC
2025-08-20Z-2314-2025Class IIGE SIGNA Premier EliteGE Medical Systems, LLC
2025-08-20Z-2315-2025Class IIGE SIGNA Premier MAXGE Medical Systems, LLC
2025-08-20Z-2316-2025Class IIGE SIGNA Hero XTGE Medical Systems, LLC
2025-08-20Z-2317-2025Class IIGE SIGNA Hero EliteGE Medical Systems, LLC
2025-08-20Z-2318-2025Class IIGE SIGNA Hero MAXGE Medical Systems, LLC
2025-08-20Z-2319-2025Class IIGE SIGNA PET/MR AIRGE Medical Systems, LLC
2025-08-20Z-2320-2025Class IIGE SIGNA PET/MR AIR PlusGE Medical Systems, LLC
2025-08-20Z-2321-2025Class IIIDescription/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137CareFusion 303, Inc.
2025-08-20Z-2322-2025Class IIAccess Thyroglobulin assayBeckman Coulter, Inc.
2025-08-20Z-2323-2025Class IIHemosIL LMW Heparin ControlsInstrumentation Laboratory
2025-08-20Z-2324-2025Class IIIZvu Anorectal Manometry Procedure KitDiversatek Healthcare
2025-08-13Z-2129-2025Class IPlum Duo Infusion SystemICU Medical, Inc.
2025-08-13Z-2176-2025Class IMicrobore Extension Set with 0B BRAUN MEDICAL INC
2025-08-13Z-2179-2025Class IBD Alaris Pump Module ModelCareFusion 303, Inc.
2025-08-13Z-2180-2025Class IBD Alaris Pump Infusion Sets REF: 10013186CareFusion 303, Inc.
2025-08-13Z-2182-2025Class IBritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref:…Flexicare Medical (Dongguan) Ltd.
2025-08-13Z-2183-2025Class IBritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331UFlexicare Medical (Dongguan) Ltd.
2025-08-13Z-2184-2025Class IBritePro Solo Mini with Pro Miller Blade Size 1Flexicare Medical (Dongguan) Ltd.
2025-08-13Z-2185-2025Class IBritepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle…Flexicare Medical (Dongguan) Ltd.
2025-08-13Z-2186-2025Class IBritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle…Flexicare Medical (Dongguan) Ltd.
2025-08-13Z-2187-2025Class IBritePro Solo Single-Use Fiber Optic Laryngoscope Handle…Flexicare Medical (Dongguan) Ltd.
2025-08-13Z-2237-2025Class IIBD Trucount ControlsBecton, Dickinson and Company, BD Bio Sciences
2025-08-13Z-2238-2025Class IIBD Trucount ControlsBecton, Dickinson and Company, BD Bio Sciences
2025-08-13Z-2239-2025Class IIPinnacle 3 with TumorLOCPhilips Medical Systems (Cleveland) Inc
2025-08-13Z-2240-2025Class IILAPAROSCOPIC TRAYAVID Medical, Inc.
2025-08-13Z-2241-2025Class IICARDIAC ROBOT PACKAVID Medical, Inc.
2025-08-13Z-2242-2025Class IICT DAVINCIAVID Medical, Inc.
2025-08-13Z-2243-2025Class IIDA VINCI PACK URO/PROSTATEAVID Medical, Inc.
2025-08-13Z-2244-2025Class IIDAVINCI TRUCUSTOM BUNDLEAVID Medical, Inc.
2025-08-13Z-2245-2025Class IIDAVINCI UROLOGYAVID Medical, Inc.
2025-08-13Z-2246-2025Class IIGEN LAPAROSCOPY PACKAVID Medical, Inc.
2025-08-13Z-2247-2025Class IIGENERAL LAPAROSCOPY TRAYAVID Medical, Inc.
2025-08-13Z-2248-2025Class IIGENERAL ROBOTIC PACKAVID Medical, Inc.
2025-08-13Z-2249-2025Class IIGS ENDOSCOPY PACKAVID Medical, Inc.
2025-08-13Z-2250-2025Class IIGYN LAPAROSCOPY PACKAVID Medical, Inc.
2025-08-13Z-2251-2025Class IIGYN ROBOTIC PACKAVID Medical, Inc.
2025-08-13Z-2252-2025Class IIHVI CARDIAC ROBOT PACKAVID Medical, Inc.
2025-08-13Z-2253-2025Class IILAP CHOLE PACKAVID Medical, Inc.
2025-08-13Z-2254-2025Class IILAPAROSCOPIC GYNAVID Medical, Inc.
2025-08-13Z-2255-2025Class IILAPAROSCOPIC PROSTATECTOMYAVID Medical, Inc.
2025-08-13Z-2256-2025Class IILAPAROSCOPY PACKAVID Medical, Inc.
2025-08-13Z-2257-2025Class IILAVH PACKAVID Medical, Inc.
2025-08-13Z-2258-2025Class IIMAJOR THORACOSCOPY BASINAVID Medical, Inc.
2025-08-13Z-2259-2025Class IIPACK GENERAL ROBOTICAVID Medical, Inc.
2025-08-13Z-2260-2025Class IIPARTIAL NEPHRECTOMYAVID Medical, Inc.
2025-08-13Z-2261-2025Class IIPARTIAL NEPHRECTOMY PACKAVID Medical, Inc.
2025-08-13Z-2262-2025Class IIROBOTIC PROSTATECTOMY PACKAVID Medical, Inc.
2025-08-13Z-2263-2025Class IIROBOTIC URO/GYN PACKAVID Medical, Inc.
2025-08-13Z-2264-2025Class IIUIBCBeckman Coulter Inc.
2025-08-13Z-2265-2025Class IIIBrand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog…DRG International, Inc.
2025-08-13Z-2266-2025Class IIUniCel DxI 800 Access Immunoassay AnalyzerBeckman Coulter, Inc.
2025-08-13Z-2267-2025Class IIDxI 800 Access Immunoassay Analyzer W/Dual GantryBeckman Coulter, Inc.
2025-08-13Z-2268-2025Class IIDxI 800 Access Immunoassay Analyzer W/Spot BBeckman Coulter, Inc.
2025-08-13Z-2269-2025Class IIUniCel DxI 600 Access Immunoassay AnalyzerBeckman Coulter, Inc.
2025-08-13Z-2270-2025Class IIDxI 600 Access Immunoassay Analyzer W/Dual GantryBeckman Coulter, Inc.
2025-08-13Z-2271-2025Class IIDxI 600 Access Immunoassay Analyzer W/Spot BBeckman Coulter, Inc.
2025-08-13Z-2272-2025Class IIepoc BGEM BUN Test Card [25pk]Siemens Healthcare Diagnostics Inc
2025-08-13Z-2274-2025Class IIDASH SARS-CoV-2 & Flu A/B Test Model/Catalog Number: SG-0006…Nuclein LLC
2025-08-13Z-2275-2025Class IIOne-piece Guedel airwayIntersurgical Inc
2025-08-13Z-2276-2025Class IIOne-piece Guedel airwayIntersurgical Inc
2025-08-13Z-2277-2025Class IIStryker SmartPump TourniquetStryker Corporation
2025-08-06Z-2150-2025Class IIMolding EquipmentApic Yamada America
2025-08-06Z-2158-2025Class ISafeStar 90 Plus FilterDraeger, Inc.
2025-08-06Z-2159-2025Class ISafeStar 55 Plus FilterDraeger, Inc.
2025-08-06Z-2160-2025Class IHME TwinStar HEPA Plus FilterDraeger, Inc.

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