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

59,336 records, page 15 of 1187
FDA device recalls, page 15 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2412-2026Class IIPhilips Allura Xper with the following Model Numbers: Model # 722001 for Allura Xper...Philips Medical Systems Nederland B.V.OWB
Z-2411-2026Class IIPhilips MultiDiagnost Eleva with the following Model Numbers: Model # 708032 for...Philips Medical Systems Nederland B.V.IZI
Z-2305-2026Class IIDeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6"...DeRoyal Industries, Inc.NAC
Z-2713-2026Class IIGSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used...Wallac OyKQP
Z-2457-2026Class IImpella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.Abiomed, Inc.OZD
Z-2615-2026Class IReprocessed Electrophysiology Catheters and Ultrasound Catheters Item no. 401206RH, St...MEDLINE INDUSTRIES, LP - NorthfieldNLH
Z-2450-2026Class IIALYON Surgical Lighting SystemSTERIS CorporationFSY
Z-2449-2026Class IIHarmonyAIR A-Series Surgical Lighting SystemSTERIS CorporationFSY
Z-2448-2026Class IIHarmonyAIR A-Series Surgical Lighting SystemSTERIS CorporationFSY
Z-2474-2026Class IIConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 100mm...ConMed CorporationHIF
Z-2473-2026Class IIConMed AirSeal 12mm Access Port and Low Profile Obturator with Bladeless Optical Tip...ConMed CorporationHIF
Z-2472-2026Class IIConMed AirSeal 12mm Access Port and Palm Grip Obturator with Bladeless Optical Tip, 150mm...ConMed CorporationHIF
Z-2471-2026Class IIConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip...ConMed CorporationHIF
Z-2470-2026Class IIConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip...ConMed CorporationHIF
Z-2469-2026Class IIConMed AirSeal 5mm Access Port and Low Profile Obturator with Bladeless Optical Tip, 75mm...ConMed CorporationHIF
Z-2468-2026Class IIConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip...ConMed CorporationHIF
Z-2467-2026Class IIConMed AirSeal 8mm Access Port and Low Profile Obturator with Bladeless Optical Tip...ConMed CorporationHIF
Z-2466-2026Class IIConMed AirSeal 12mm Access Port and Obturator with Blunt Tip, 100mm Length. Catalog...ConMed CorporationHIF
Z-2465-2026Class IIConMed AirSeal 12 mm Access Port and Obturator with Blunt Tip, 120mm Length. Catalog...ConMed CorporationHIF
Z-2464-2026Class IIConMed AirSeal 5 mm Smooth Access Port and Obturator with Blunt Tip, 150mm Length...ConMed CorporationHIF
Z-2360-2026Class IAutomated Impella Controller (AIC), for use with left heart support blood pump. Labeled...Abiomed, Inc.OZD
Z-2792-2026Class IPack Angiography NCMC 3/Cs BANNER, REF: NCAG62I, containing Medline Namic Angiographic...Medical Action Industries, Inc. 306OEZ
Z-2950-2026Class IIEndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFU...Medtronic, Inc.FFX
Z-2520-2026Class IIBrand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog...Abbott MedicalDSQ
Z-2519-2026Class IIBrand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number...Abbott MedicalDSQ
Z-2518-2026Class IIBrand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS)...Abbott MedicalDSQ
Z-2793-2026Class IISafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix SystemAlphatec Spine, Inc.GWF
Z-2241-2026Class IIMedtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator...Medtronic NeuromodulationMHY
Z-2240-2026Class IIMedtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator...Medtronic NeuromodulationMHY
Z-3163-2026Class IIIV Sets with drip chambersICU Medical, Inc.FMG
Z-3162-2026Class IIIV Sets with drip chambersICU Medical, Inc.FRN
Z-3161-2026Class IIIV Sets with drip chambersICU Medical, Inc.ONB
Z-3160-2026Class IIIV Sets with drip chambersICU Medical, Inc.FPA
Z-3159-2026Class IIOncology sets with drip chambersICU Medical, Inc.ONB
Z-3158-2026Class IIOncology sets with drip chambersICU Medical, Inc.FPA
Z-3157-2026Class IIIV Non-Dedicated Gravity Administration Sets with drip chambersICU Medical, Inc.FMG
Z-3156-2026Class IIPlum administration setsICU Medical, Inc.FPA
Z-2413-2026Class IIOrca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca...Boston Scientific CorporationODC
Z-2577-2026Class IIOctopus 4 Tissue Stabilizer, Model 29400Medtronic Perfusion SystemsMWS
Z-2576-2026Class IIOctopus Evolution AS Tissue Stabilizer, Model TS2500Medtronic Perfusion SystemsMWS
Z-2575-2026Class IIOctopus Evolution Tissue Stabilizer, Model TS2000Medtronic Perfusion SystemsMWS
Z-2405-2026Class IIMerlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 softwareAbbott MedicalPNJ
Z-2321-2026Class IIBicarby" Dialysate; Model Numbers: RFP-400-G, RFP-401-G, RFP-402-G, RFP-404-G, RFP-407-G...Fresenius Medical Care Renal Therapies Group, LLCKPO
Z-2745-2026Class IIPower Over Fiber Base ModuleTerex UtilitiesRFN
Z-2578-2026Class IIBrand Name: Persona Revision Product Name: Persona Revision Trabecular Metal Femoral...Zimmer GmbHMBH
Z-2580-2026Class IIIntera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug...Boston Scientific CorporationLKK
Z-2702-2026Class II5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and...Fresenius Medical Care Renal Therapies Group, LLCKDI
Z-2516-2026Class IIBrand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation...Inspire Medical Systems IncMNQ
Z-2515-2026Class IIBrand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing...Inspire Medical Systems IncMNQ
Z-2355-2026Class IINeoSpan SuperElastic Compression Staple w/Instruments Catalog Number and Product...In2bones USA, LLCJDR