510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR

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

59,544 records, page 650 of 1191
FDA device recalls, page 650 of 1191
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2041-2015Class IIArthroscopy Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2040-2015Class IIOrthopedic Split Drape Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2039-2015Class IIDND Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2038-2015Class IICustom Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2037-2015Class IIBlepharoplasty Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2036-2015Class IISet Up Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2035-2015Class IIFace Lift Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2034-2015Class IIPediatric Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2033-2015Class IIOpen Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2032-2015Class IICysto Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2031-2015Class IINeurosurgery Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2030-2015Class IIMinor Pack and Minor Pack II Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2029-2015Class IIPodiatry Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2028-2015Class IIHand Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2027-2015Class IIENT Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2026-2015Class IIKnee Arthro Pack and Knee Arthro Pack II - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2025-2015Class IIShoulder Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2024-2015Class IIGlaucoma Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2023-2015Class IIEye Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2022-2015Class IIHead & Neck Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2021-2015Class IIGyn Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2020-2015Class IIStradi 4500 - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2019-2015Class IIAbdominal Pack and Abdom Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2018-2015Class IIFace Neck Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2017-2015Class IIBariatric Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2016-2015Class IIVasc Custom Kit - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2015-2015Class IISkin and Vein Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2014-2015Class IILima Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2013-2015Class IIHand Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2012-2015Class IIACL Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2011-2015Class IISuction Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2010-2015Class IIPlastic Pack and Plastic HNP Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2009-2015Class IIFace Lift Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2008-2015Class IIMississippi Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2007-2015Class IISurgical Pack and General Surgery Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2006-2015Class IITummy Tuck Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2005-2015Class IIBreast Augmentation Pack and Breast Augmentation Expanded Pack - contains Devon Light...Gyn-Disposables, Inc.LRO
Z-2004-2015Class IILaser Evlt Pack and Laser One Leg Evlt - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2003-2015Class IIVein & Vascular Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2002-2015Class IIGeneral Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2001-2015Class IIVaginal Rejuvenation Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-2000-2015Class IILipo/Buttocks Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-1999-2015Class IILipo Pack, Liposuction Expended Pack, and Liposuction Tray - contains Devon Light...Gyn-Disposables, Inc.LRO
Z-1998-2015Class IIStandard Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-1997-2015Class IIPhleb Pack and Laser Phleb Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-1996-2015Class IIEndovenous Kit, Endo Pack and Endovenous Laser Kit - contains Devon Light Glove Used...Gyn-Disposables, Inc.LRO
Z-1995-2015Class IIVein Pack, Vein Treatment II Pack, Vein Brunswick Pack, Vein No Lidocaine Pack, Vein...Gyn-Disposables, Inc.LRO
Z-1994-2015Class IIAdvanced Vein Care - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-1993-2015Class IIBasic Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO
Z-1992-2015Class IIBreast Pack - contains Devon Light Glove Used during surgeryGyn-Disposables, Inc.LRO