510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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

59,476 records, page 965 of 1190
FDA device recalls, page 965 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1305-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387326...Argon Medical Devices, IncDQX
Z-1304-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387325...Argon Medical Devices, IncDQX
Z-1303-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387323...Argon Medical Devices, IncDQX
Z-1302-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387322...Argon Medical Devices, IncDQX
Z-1301-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387321...Argon Medical Devices, IncDQX
Z-1300-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387320...Argon Medical Devices, IncDQX
Z-1299-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387319...Argon Medical Devices, IncDQX
Z-1298-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387318...Argon Medical Devices, IncDQX
Z-1297-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387316...Argon Medical Devices, IncDQX
Z-1296-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387314...Argon Medical Devices, IncDQX
Z-1295-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387313...Argon Medical Devices, IncDQX
Z-1294-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387312...Argon Medical Devices, IncDQX
Z-1293-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387311...Argon Medical Devices, IncDQX
Z-1292-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387310...Argon Medical Devices, IncDQX
Z-1291-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387309...Argon Medical Devices, IncDQX
Z-1290-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387308...Argon Medical Devices, IncDQX
Z-1289-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387307...Argon Medical Devices, IncDQX
Z-1288-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387306...Argon Medical Devices, IncDQX
Z-1287-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387305...Argon Medical Devices, IncDQX
Z-1286-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387304...Argon Medical Devices, IncDQX
Z-1285-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387303...Argon Medical Devices, IncDQX
Z-1284-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387302...Argon Medical Devices, IncDQX
Z-1283-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387301...Argon Medical Devices, IncDQX
Z-1282-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087326...Argon Medical Devices, IncDQX
Z-1281-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087317...Argon Medical Devices, IncDQX
Z-1280-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087316...Argon Medical Devices, IncDQX
Z-1279-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087315...Argon Medical Devices, IncDQX
Z-1278-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087314...Argon Medical Devices, IncDQX
Z-1277-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087313...Argon Medical Devices, IncDQX
Z-1276-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087312...Argon Medical Devices, IncDQX
Z-1275-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087311...Argon Medical Devices, IncDQX
Z-1274-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087309...Argon Medical Devices, IncDQX
Z-1273-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087308...Argon Medical Devices, IncDQX
Z-1272-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087306...Argon Medical Devices, IncDQX
Z-1271-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087305...Argon Medical Devices, IncDQX
Z-1270-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087304...Argon Medical Devices, IncDQX
Z-1269-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087303...Argon Medical Devices, IncDQX
Z-1268-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087302...Argon Medical Devices, IncDQX
Z-1389-2009Welch Allyn AED 10 automated external defibrillator and MRL Jumpstart (collectively "AED...Welch Allyn Protocol, Inc.MKJ
Z-1267-2009Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087301...Argon Medical Devices, IncDQX
Z-1637-2009Flite Clip Slings; patient specific disposable sling; Manufactured in Belgium for Medibo...Arjohuntleigh ABFSA
Z-1636-2009Passive Clip Slings; washable sling; Manufactured in Belgium for Medibo NV, Heikant 5...Arjohuntleigh ABFSA
Z-1392-2009ARCHITECT Reaction Vessel, 2000 units per carton; for in vitro diagnostic use with the...Abbott MedicalJJE
Z-0555-2010Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7...Zimmer GmbHHSX
Z-1424-2009Medtronic, Transfer Spike, Blood Processing Accessory, REF BT945, Sequestration KitsMedtronic Perfusion SystemsDWE
Z-1325-2009TheraSphere Administration Set (Part Number K125914-034). TheraSphere is indicated for...Bwxt Medical Ltd.NAW
Z-1227-2009GE Healthcare ApexPro Telemetry System for mobile patient physiological monitoring.GE HealthcareMHX
Z-1487-2012Insight rev H software. The InSIGHT Gastrointestinal Motility System is intended for...Diversatek Healthcare IncFFX
Z-0917-2010Sealapex Express (Part Number: 33639), root canal filling material. Manufactured by...Sybron Dental Specialties, Inc.KIF
Z-0916-2010Herculite Ultra (Part Number 34333), dental composite resorative material. Manufactured...Sybron Dental Specialties, Inc.EBF