510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,460 records, page 75 of 1190
FDA device recalls, page 75 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2308-2025Class IIGE SIGNA Hero, Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-2307-2025Class IIGE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-2306-2025Class IIGE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-2305-2025Class IIGE SIGNA UHP, Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-2304-2025Class IIGE SIGNA Premier, Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-2303-2025Class IIGE SIGNA Architect, Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-2302-2025Class IIGE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-2301-2025Class IIGE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-2300-2025Class IIGE Signa Voyager, Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-2299-2025Class IIGE Signa Artist, Nuclear Magnetic Resonance Imaging SystemGE HealthcareLNH
Z-2276-2025Class IIOne-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.Intersurgical Ltd.CAE
Z-2275-2025Class IIOne-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.Intersurgical Ltd.CAE
Z-2096-2025Class IBaxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2Baxter Healthcare CorporationPHC
Z-2095-2025Class IBaxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAXBaxter Healthcare CorporationPHC
Z-2805-2026Class IIM5 Corpus Power Wheelchair REF,120032Permobil, ABITI
Z-2117-2025Class IIPortable X-ray systemDigimed Co., LtdEHD
Z-2222-2025Class IIBrand Name: Osteotec Product Name: Osteotec Silicone Finger Implant Model/Catalog Number...Osteotec LimitedKYJ
Z-2169-2025Class IIMedtronic CareLink SmartSync Device Manager, Model Number 24967A with the following...Medtronic, Inc.NVZ
Z-2168-2025Class IIMedtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following...Medtronic, Inc.NVZ
Z-2138-2025Class IINatus Brain Monitor Breakout Box, Part Number 021911; full-montage standard...Natus Medical IncorporatedGWQ
Z-2462-2025Class IIBardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone...C.R. Bard IncEZL
Z-2171-2025Class IIStryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable TipStryker Corp.GCX
Z-2170-2025Class IIStryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable...Stryker Corp.GCJ
Z-2146-2025Class IICone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS. The Ellik...OLYMPUS Corporation of the AmericasKQT
Z-2145-2025Class IIEllik Evacuator Adapter, Locking. Model Number: 190-NRS. The Ellik Evacuator and...OLYMPUS Corporation of the AmericasKQT
Z-2144-2025Class IIEllik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator and adapter...OLYMPUS Corporation of the AmericasKQT
Z-2143-2025Class IIEllik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are...OLYMPUS Corporation of the AmericasKQT
Z-2142-2025Class IITubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator...OLYMPUS Corporation of the AmericasKQT
Z-2141-2025Class IIGlass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator and adapter...OLYMPUS Corporation of the AmericasKQT
Z-2140-2025Class IIGreen Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR. Model Number...OLYMPUS Corporation of the AmericasHIH
Z-2139-2025Class IIBlue Silicone, Reusable Silicone Seal 6 - 12 FR. Model Number: CS-B612. The reusable...OLYMPUS Corporation of the AmericasHIH
Z-2545-2025Class IIQuickVue: Dipstick Strep A Test: 50T, REF: 20108; 25T, REF: 20125; 50T, SCN, REF: 20108SCOrtho-Clinical Diagnostics, Inc.GTY
Z-2521-2025Class IIMI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a...Caris MPI, IncPQP
Z-2128-2025Class IIMedtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number...Medtronic, Inc.KRG
Z-2127-2025Class IIMedtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967...Medtronic, Inc.KRG
Z-2102-2025Class Ii-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope is...Intersurgical Ltd.CCW
Z-2124-2025Class IIKWIK-STIK and LYFO DISK, quality control kit for culture media Catalog # 0805K and 0805LMicrobiologics, Inc.JTR
Z-2496-2025Class IIInPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)Medtronic, Inc.NDC
Z-2166-2025Class IIBiofinity Toric Multifocal Contact LensCooperVision, Inc.LPM
Z-2165-2025Class IIBiofinity XR Toric Contact LensCooperVision, Inc.LPM
Z-2199-2025Class IISwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE010301MEDLINE INDUSTRIES, LP - NorthfieldQBP
Z-2453-2025Class IIBD PhaSeal Injector Luer (N30C), REF: 515001 BD PhaSeal Injector Luer Lock (N35), REF...BD Switzerland SARLONB
Z-2161-2025Class ISafeStar 60A Plus Filter. Bidirectionally breathing system filter.Draeger, Inc.CAH
Z-2160-2025Class IHME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.Draeger, Inc.CAH
Z-2159-2025Class ISafeStar 55 Plus Filter. Bidirectionally breathing system filter.Draeger, Inc.CAH
Z-2158-2025Class ISafeStar 90 Plus Filter. Bidirectionally breathing system filter.Draeger, Inc.CAH
Z-2221-2025Class IIVolcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF...Volcano CorporationOBJ
Z-2156-2025Class IIMedline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as...MEDLINE INDUSTRIES, LP - NorthfieldOHM
Z-2155-2025Class IIMedline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as...MEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-2154-2025Class IIMedline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as...MEDLINE INDUSTRIES, LP - NorthfieldLRS