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 65 of 1190
FDA device recalls, page 65 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0201-2026Class IICLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated...Baxter Healthcare CorporationFMG
Z-0200-2026Class IICLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standard Bore, 1.2...Baxter Healthcare CorporationFMG
Z-0199-2026Class IICLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK...Baxter Healthcare CorporationFMG
Z-0198-2026Class IICLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK...Baxter Healthcare CorporationFMG
Z-0197-2026Class IICLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, CLEARLINK...Baxter Healthcare CorporationFMG
Z-0196-2026Class IICLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, three CLEARLINK...Baxter Healthcare CorporationFMG
Z-0195-2026Class IICLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two CLEARLINK...Baxter Healthcare CorporationFMG
Z-0194-2026Class IICLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated...Baxter Healthcare CorporationFMG
Z-0193-2026Class IICLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer Activated...Baxter Healthcare CorporationFMG
Z-0192-2026Class IICLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated...Baxter Healthcare CorporationFMG
Z-0191-2026Class IICLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, 10...Baxter Healthcare CorporationFMG
Z-0190-2026Class IICLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 drops/mL...Baxter Healthcare CorporationFMG
Z-0189-2026Class IICONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck...Baxter Healthcare CorporationFMG
Z-0025-2026Class IINES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number...Northeast Scientific Inc.QTF
Z-0024-2026Class IINES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number...Northeast Scientific Inc.QTF
Z-0023-2026Class IINES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number...Northeast Scientific Inc.QTF
Z-0022-2026Class IINES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number...Northeast Scientific Inc.QTF
Z-0021-2026Class IINES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number...Northeast Scientific Inc.QTF
Z-0020-2026Class IINES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number...Northeast Scientific Inc.QTF
Z-0019-2026Class IINES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number...Northeast Scientific Inc.QTF
Z-0041-2026Class IIOptiflux High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS...Fresenius Medical Care Renal Therapies Group, LLCFJI
Z-0016-2026Class IIGetinge 88-Series Washer- Disinfector. Model Number: 88-5.Getinge Disinfection ABMEC
Z-0018-2026Class IINES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number...Northeast Scientific Inc.QTF
Z-0038-2026Class IIClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE...IMACOR, IncITX
Z-0160-2026Class IIDuoDERM" Extra Thin dressings are highly flexible, control gel formula dressings designed...ConvaTec LimitedNAD
Z-0318-2026Class IBrand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6...Dexcom, Inc.QBJ
Z-2640-2025Class II1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM...Howmedica Osteonics CorpJDI
Z-2668-2025Class IMAGNETOM Vida Fit. Model Number: 11410481.Siemens Medical Solutions USA, Inc.LNH
Z-2667-2025Class IMAGNETOM Vida (DE). Model Number: 11060815. 510(k): K170396, K173617, K181433...Siemens Medical Solutions USA, Inc.LNH
Z-2666-2025Class IMAGNETOM Verio Dot Upgrade. Model Number: 10684334.Siemens Medical Solutions USA, Inc.LNH
Z-2665-2025Class IMAGNETOM Verio Dot. Model Number: 10684333.Siemens Medical Solutions USA, Inc.LNH
Z-2664-2025Class IMAGNETOM Verio. Model Number: 10276755.Siemens Medical Solutions USA, Inc.LNH
Z-2663-2025Class IMAGNETOM Spectra as the following: 1. MAGNETOM Spectra. Model Number: 10837643. 2...Siemens Medical Solutions USA, Inc.LNH
Z-2662-2025Class IMAGNETOM Skyra Fit BioMatrix. Model Number: 11516217.Siemens Medical Solutions USA, Inc.LNH
Z-2661-2025Class IMAGNETOM Skyra fit. Model Number: 10849580.Siemens Medical Solutions USA, Inc.LNH
Z-2660-2025Class IMAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510...Siemens Medical Solutions USA, Inc.LNH
Z-2659-2025Class IMAGNETOM Prisma. Model Number: 10849582.Siemens Medical Solutions USA, Inc.LNH
Z-2658-2025Class IMAGNETOM Lumina (DE). Model Number: 11344916.Siemens Medical Solutions USA, Inc.LNH
Z-2657-2025Class IMAGNETOM Connectom.X. Model Number: 11371480.Siemens Medical Solutions USA, Inc.LNH
Z-2656-2025Class IMAGNETOM Cima.X (DE). Model Number: 11647158.Siemens Medical Solutions USA, Inc.LNH
Z-2655-2025Class IBIOGRAPH One (DE). Model Number: 11689172.Siemens Medical Solutions USA, Inc.LNH
Z-2654-2025Class IBiograph mMR. Model Number: 10433372.Siemens Medical Solutions USA, Inc.OUO
Z-2618-2025Class IIExtractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2)...Boston Scientific CorporationFGE
Z-0409-2026Class IISharesource Connectivity Platform for Use with Homechoice Claria Product Code...Baxter Healthcare CorporationFKX
Z-0998-2026Class IIThe AlignRT InBore system contains six Class 1 lasers which enables the system s cameras...Vision Rt IncIWE
Z-0315-2026Class IIOsstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.OSSTEM Implant Co., Ltd.OAS
Z-0314-2026Class IIOsstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS.OSSTEM Implant Co., Ltd.OAS
Z-0313-2026Class IIOsstem Dental X-Ray System T1. Product Model Numbers T1-C and T1-CS.OSSTEM Implant Co., Ltd.OAS
Z-0036-2026Class IIGORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W...W. L. Gore & Associates, Inc.DSY
Z-0072-2026Class IIArtegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636M, AG730M...LeMaitre Vascular Inc.LXA