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 138 of 1190
FDA device recalls, page 138 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-3075-2024Class IISyringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock...Sol-Millennium Medical, Inc.FMF
Z-3074-2024Class IISyringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed...Sol-Millennium Medical, Inc.FMF
Z-2247-2024Class IIFirst Source iQ Flex M. Portable cart and platform that supports an X-ray system and...First Source IncIZL
Z-2246-2024Class IIFirst Source Vision M. Portable cart and platform that supports an X-ray system and...First Source IncIZL
Z-2154-2024Class IIBard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical...C.R. Bard IncMJC
Z-2219-2024Class IIStryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.Stryker Corp.KTT
Z-2325-2024Class IIKosmos on iOS impacting iOS, Model Numbers: P007639, P007944, software is part of a...Echonous IncIYN
Z-2028-2024Class IIPhilips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual...Remote Diagnostic Technologies Ltd.LDD
Z-2351-2024Class IIBD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD...Becton, Dickinson and Company, BD BiosciencesOYE
Z-2019-2024Class IIIVITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly...Ortho-Clinical Diagnostics, Inc.JJX
Z-2151-2024Class IICentrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments...Baxter Healthcare CorporationIOQ
Z-1920-2024Class IMEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode...Megadyne Medical Products, IncGEI
Z-1921-2024Class IThoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US, L1286A-US...Abbott MedicalDSQ
Z-3095-2024Class IIMedline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only...MEDLINE INDUSTRIES, LP - NorthfieldNLQ
Z-3094-2024Class IIMedline ReNewal Reprocessed Covidien LigaSure Impact, Sealer/Divider, Nano-Coated...MEDLINE INDUSTRIES, LP - NorthfieldNUJ
Z-3093-2024Class IIMedline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated...MEDLINE INDUSTRIES, LP - NorthfieldNUJ
Z-3092-2024Class IIMedline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated...MEDLINE INDUSTRIES, LP - NorthfieldNUJ
Z-2449-2024Class IPlum 360/A+ spare batteries. Item Number: SUB0000864.Abbott MedicalFRN
Z-2448-2024Class IReplacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3...Abbott MedicalFRN
Z-2447-2024Class IReplacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List...Abbott MedicalFRN
Z-2135-2024Class IICORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intended to assist...Blue Belt Technologies, Inc.OLO
Z-2138-2024Class IICODMAN BACTISEAL Clear EVD Catheter 1.9mm I.D. Catheter Set- indicated for gaining access...Integra LifeSciences CorporationJXG
Z-2137-2024Class IICODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the...Integra LifeSciences CorporationJXG
Z-2136-2024Class IICODMAN BACTISEAL EVD Catheter Set - Indicated for gaining access to the ventricles of...Integra LifeSciences CorporationJXG
Z-2023-2024Class IIBD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal...Becton Dickinson & CoQJR
Z-2524-2024Class IIAmerican Contract Systems Spine Pack convenience kitAmerican Contract Systems, Inc.OJG
Z-2523-2024Class IIAmerican Contract Systems Biopsy Drape Pack convenience kitAmerican Contract Systems, Inc.FCH
Z-2522-2024Class IIAmerican Contract Systems Cataract Pack convenience kitAmerican Contract Systems, Inc.OJK
Z-2521-2024Class IIAmerican Contract Systems Extremity convenience kit, American Contract Systems Hand Pack...American Contract Systems, Inc.OJH
Z-2520-2024Class IIAmerican Contract Systems Special Procedure Pack convenience kitAmerican Contract Systems, Inc.OEQ
Z-2519-2024Class IIAmerican Contract Systems Laparoscopy Litho Std Pack convenience kit and American...American Contract Systems, Inc.FDE
Z-2518-2024Class IIAmerican Contract Systems Gyn Laparoscopy convenience kitAmerican Contract Systems, Inc.OHD
Z-2517-2024Class IIAmerican Contract Systems Hand Pack convenience kitAmerican Contract Systems, Inc.LRO
Z-2217-2024Class IINovaGuide 2 Traditional Ultrasound , REF: NSC-TCDNG2NeuraSignal, Inc.IYN
Z-2216-2024Class IINovaGuide 2 Intelligent Ultrasound, REFs: NSC-NVGSYS2 & NSC-NVGSYS2-CANeuraSignal, Inc.IYN
Z-2244-2024Class IIEVOLUTION MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement...Microport Orthopedics Inc.HRY
Z-2018-2024Class IIFLIXENE, 4-7X30, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graftAtrium Medical CorporationDSY
Z-2017-2024Class IIFLIXENE, 4-7X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graftAtrium Medical CorporationDSY
Z-2016-2024Class IIFLIXENE, 4-6X45, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graftAtrium Medical CorporationDSY
Z-2015-2024Class IIFLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graftAtrium Medical CorporationDSY
Z-2014-2024Class IIFLIXENE, 4-6X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graftAtrium Medical CorporationDSY
Z-2013-2024Class IIFLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graftAtrium Medical CorporationDSY
Z-2012-2024Class IIFLIXENE, 4-6X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graftAtrium Medical CorporationDSY
Z-2011-2024Class IIFLIXENE, 6X30, 1GDS, STR. Single-Ended Slider GDS. Vascular graftAtrium Medical CorporationDSY
Z-2010-2024Class IIFLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graftAtrium Medical CorporationDSY
Z-2009-2024Class IIFLIXENE, 6X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graftAtrium Medical CorporationDSY
Z-2008-2024Class IIFLIXENE, 7X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graftAtrium Medical CorporationDSY
Z-2007-2024Class IIFLIXENE, 6X30, 1GDS, GW. Single-Ended Slider GDS. Vascular graftAtrium Medical CorporationDSY
Z-2006-2024Class IIFLIXENE, 7X80, 1GDS, GW. Single-Ended Slider GDS. Vascular graftAtrium Medical CorporationDSY
Z-2005-2024Class IIFLIXENE, 7X40, 1GDS, GW. Single-Ended Slider GDS. Vascular graftAtrium Medical CorporationDSY