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 71 of 1190
FDA device recalls, page 71 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2420-2025Class IICorin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4)...Maquet Cardiovascular Us Sales, LLCFQO
Z-2297-2025Class II3mensio Workstation (Vascular Fenestrated) softwarePIE Medical Imaging B.V.LLZ
Z-2173-2025Class IBaxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUSBaxter Healthcare CorporationFRN
Z-2425-2025Class IIELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED...Onkos Surgical, Inc.JDI
Z-2424-2025Class IIELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED...Onkos Surgical, Inc.JDI
Z-2423-2025Class IIELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem...Onkos Surgical, Inc.JDI
Z-2226-2025Class IIBlood/MacConkey Biplate 100/PK, Product Number R02049Remel IncJSI
Z-2225-2025Class IIBlood/EMB, Levine 100/PK, Product Number R02041Remel IncJSI
Z-2224-2025Class IIStrep Selective II Agar, Product Number R01859Remel IncJSI
Z-2223-2025Class IIBlood Agar,5% Sheep Blood 100/PK, Product Number R01202Remel IncJSH
Z-2129-2025Class IPlum Duo Infusion System, List Number: 400020401Abbott MedicalFRN
Z-2187-2025Class IBritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310UFlexicare Medical (Dongguan) Ltd.CCW
Z-2186-2025Class IBritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309UFlexicare Medical (Dongguan) Ltd.CCW
Z-2185-2025Class IBritepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000UFlexicare Medical (Dongguan) Ltd.CCW
Z-2184-2025Class IBritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415UFlexicare Medical (Dongguan) Ltd.CCW
Z-2183-2025Class IBritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U...Flexicare Medical (Dongguan) Ltd.CCW
Z-2182-2025Class IBritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac...Flexicare Medical (Dongguan) Ltd.CCW
Z-2459-2025Class IIDM-ARLITE-R. Electrical wheelchair component.MO-Vis BVKNN
Z-2458-2025Class IAll-round Joystick R-net Light. Electrical wheelchair component.MO-Vis BVKNN
Z-2457-2025Class IIDM-MULTI-R. Electrical wheelchair component.MO-Vis BVKNN
Z-2456-2025Class IIDM-MICRO-R. Electrical wheelchair component.MO-Vis BVKNN
Z-2455-2025Class IMulti Joystick R-net. Electrical wheelchair component.MO-Vis BVKNN
Z-2454-2025Class IMicro Joystick R-net. Electrical wheelchair component.MO-Vis BVKNN
Z-2609-2025Class IIFilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative, multiplexed, nucleic...BioFire Defense, LLCPRD
Z-2322-2025Class IIAccess Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number...Siemens Healthcare Diagnostics Inc.MSW
Z-2321-2025Class IIIDescription/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137, BD PYXIS MEDBANK MINI...CareFusion 303, IncBRY
Z-2335-2025Class IIVITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;Ortho-Clinical Diagnostics, Inc.CJY
Z-2286-2025Class IIBrand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R...Encore Medical, LPJWH
Z-2285-2025Class IIBrand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L...Encore Medical, LPJWH
Z-2176-2025Class IMicrobore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV...B Braun Medical IncFPA
Z-2181-2025Class IAmbu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog...Ambu Inc.BTM
Z-2452-2025Class IIThe Medline General Surgery Tray is customized to meet requirements of the hospitals and...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2180-2025Class IBD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check...CareFusion 303, IncFRN
Z-2558-2025Class IIVercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number...Boston Scientific Neuromodulation CorporationNHL
Z-2238-2025Class IIBD Trucount Controls, 30 Test - REF: 340335Becton, Dickinson and Company, BD BiosciencesGKZ
Z-2237-2025Class IIBD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVDBecton, Dickinson and Company, BD BiosciencesGKZ
Z-2179-2025Class IBD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versionsCareFusion 303, IncFRN
Z-2340-2025Class IIBurr Hole Cover Kit, REF: M365DB4600C0; Burr Hole Cover Spares Kit, REF: M365DB4605C0...Boston Scientific Neuromodulation CorporationNHL
Z-2273-2025Class ICarotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and...Boston Scientific CorporationNIM
Z-2272-2025Class IIepoc BGEM BUN Test Card [25pk]. Material Number: 10736515.Siemens Healthcare Diagnostics Inc.JGS
Z-2445-2025Class IIOrascoptic Superior Visualization Phantom Nose Pad Accessory Kit ( nose pad and screw) 1...Orascoptic Surgical AcuityEBA
Z-2444-2025Class IIOrascoptic Superior Visualization Dragonfly Nose Pad Accessory Kit ( nose pad and...Orascoptic Surgical AcuityFSP
Z-2414-2025Class IIIXL14-3 Transducer ProbePhilips North America LLCIYN
Z-2413-2025Class IIIX8-2t Transducer ProbePhilips North America LLCIYN
Z-2412-2025Class IIIX7-2t Transducer ProbePhilips North America LLCIYN
Z-2411-2025Class IIIX7-2 Transducer ProbePhilips North America LLCIYN
Z-2410-2025Class IIIX6-1 Transducer ProbePhilips North America LLCIYN
Z-2409-2025Class IIIX5-1c Transducer ProbePhilips North America LLCIYN
Z-2408-2025Class IIIX5-1 Transducer ProbePhilips North America LLCIYN
Z-2407-2025Class IIIX3-1 Transducer ProbePhilips North America LLCIYN