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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 173 of 1190
FDA device recalls, page 173 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0742-2024Class IIMedex 700PSI STOPCOCK W/ROTATOR, List Number MX4331RAbbott MedicalDRS
Z-0741-2024Class II6IN PRESSURE TUBING, List Number MX20617Abbott MedicalDRS
Z-0740-2024Class II1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Number MX1431MRLAbbott MedicalDRS
Z-0739-2024Class IIMedex LOGICAL CATH LAB KIT, List Number M20754Abbott MedicalDRS
Z-0508-2024Class IIDJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D...Encore Medical, LPMBH
Z-0643-2024Class IIBard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x...Bard Peripheral Vascular IncKNW
Z-0771-2024Class IIMaquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR...Maquet Cardiovascular Us Sales, LLCFSY
Z-0770-2024Class IIMaquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30...Maquet Cardiovascular Us Sales, LLCFSY
Z-0769-2024Class IIMaquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E...Maquet Cardiovascular Us Sales, LLCFSY
Z-0768-2024Class IIMaquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001...Maquet Cardiovascular Us Sales, LLCFSY
Z-0767-2024Class IIMaquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001...Maquet Cardiovascular Us Sales, LLCFSY
Z-0766-2024Class IIMaquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14...Maquet Cardiovascular Us Sales, LLCFSY
Z-0765-2024Class IIMaquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC...Maquet Cardiovascular Us Sales, LLCFSY
Z-0764-2024Class IIMaquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001...Maquet Cardiovascular Us Sales, LLCFSY
Z-0763-2024Class IIMaquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers...Maquet Cardiovascular Us Sales, LLCFSY
Z-0762-2024Class IIMaquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD QL VP01...Maquet Cardiovascular Us Sales, LLCFTD
Z-0761-2024Class IIMaquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA...Maquet Cardiovascular Us Sales, LLCFTD
Z-0760-2024Class IIMaquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF...Maquet Cardiovascular Us Sales, LLCFTD
Z-0759-2024Class IIMaquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog...Maquet Cardiovascular Us Sales, LLCFTD
Z-0758-2024Class IIMaquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model...Maquet Cardiovascular Us Sales, LLCFTD
Z-0757-2024Class IIMaquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF...Maquet Cardiovascular Us Sales, LLCFTD
Z-0696-2024Class IINIM TriVantage EMG Endotracheal Tubes, Model (REF) Numbers and sizes: a) 8229706, 6.0MM...Medtronic Xomed, Inc.ETN
Z-0655-2024Class IIAbiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are...Abiomed, Inc.DYB
Z-0654-2024Class IIAbiomed KIT, 14 Fr Introducer, 13 & 25 cm, ABMD Part of Pump Set (0048-0024...Abiomed, Inc.DYB
Z-0653-2024Class IIOscor Intro Kit, 14Fr x 13 and 25 cm Part of Pump Set (0048-0040)-Introducer(s) are...Abiomed, Inc.DYB
Z-0652-2024Class IIAbiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045...Abiomed, Inc.DYB
Z-0651-2024Class IIAbiomed Kit, 14Fr Introducer, 25cm, Long Taper Individual (0052-0039)-Introducer(s) are...Abiomed, Inc.DYB
Z-0650-2024Class IIAbiomed Kit, 14Fr Introducer, 13cm, Long Taper Individual (0052-0038)-Introducer(s) are...Abiomed, Inc.DYB
Z-0649-2024Class IIAbiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set...Abiomed, Inc.DYB
Z-0648-2024Class IIAbiomed Oscor Introducer Kit, 14Fr x Long Individual (0052-0017)- Introducer(s) are...Abiomed, Inc.DYB
Z-0647-2024Class IIOscor Introducer Kit, 14Fr x Short Individual (0052-0001)- Introducer(s) are intended for...Abiomed, Inc.DYB
Z-0646-2024Class IIAbiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the...Abiomed, Inc.DYB
Z-0553-2024Class IIThe System is designed as a modular system with components that include an Overhead Tube...GE Hangwei Medical Systems, Co. LtdKPR
Z-0552-2024Class IIThe System is designed as a modular system with components that include an Overhead Tube...GE Hangwei Medical Systems, Co. LtdKPR
Z-0556-2024Class IIINavik 3D v2, REF NAVIK3D, 3D Mapping SystemApn Health, LLCDQK
Z-0500-2024Class IILuminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic...Luminex CorporationPAM
Z-0721-2024Class IICuraplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number...Sarnova HC, LLCCAE
Z-0720-2024Class IICuraplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare...Sarnova HC, LLCCAE
Z-0697-2024Class IIOlympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a...OLYMPUS Corporation of the AmericasHET
Z-0624-2024Class IIISEROLOGY ToRCH lgM 2022 POSITIVE CONTROLI Intended for use with in vitro assays for...Randox Laboratories, LimitedOHQ
Z-0629-2024Class IIFountain, REF: IS4-135-30 and IS4-90-10, CE2797, STERILEEO, Rx ONLYMerit Medical Systems, Inc.QEY
Z-0628-2024Class IIMerit Pursue Microcatheter, REF: 28HC17130SN, 28HC17150ST/A, 29HC2015045/A...Merit Medical Systems, Inc.DQY
Z-0627-2024Class IIMerit Maestro Microcatheter, Reference Numbers: 28MC2111045/B, 28MC21110ST/B, 28MC2113045...Merit Medical Systems, Inc.KRA
Z-0515-2024Class ISterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE...Nurse Assist, LLCEZL
Z-0514-2024Class ISterile Water/Saline: Product Name/Product Code: CUP STERILE WATER FOIL LID 120...Nurse Assist, LLCFRO
Z-0513-2024Class ISterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE...Nurse Assist, LLCFRO
Z-0512-2024Class I0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240Nurse Assist, LLCNGT
Z-0555-2024Class IICARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal...Maquet Cardiovascular Us Sales, LLCDTQ
Z-0511-2024Class I0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL...Nurse Assist, LLCNGT
Z-0567-2024Class IIAC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098Physio Control, Inc.MKJ