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 144 of 1190
FDA device recalls, page 144 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-3040-2024Class IIMedline Convenience kits labeled as: 1) CHEST TUBE TRAY , Pack Number CHT2120; 2)...MEDLINE INDUSTRIES, LP - NorthfieldPAD
Z-3039-2024Class IIMedline Convenience kits labeled as: 1) OR CLEAN UP KIT, Pack Number DYK1002355X3, 2)...MEDLINE INDUSTRIES, LP - NorthfieldOKG
Z-3038-2024Class IIMedline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON...MEDLINE INDUSTRIES, LP - NorthfieldNSB
Z-3037-2024Class IIMedline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K...MEDLINE INDUSTRIES, LP - NorthfieldKKX
Z-3036-2024Class IIMedline Convenience kits labeled as: 1) SH STRL UMBILICAL ACC PACK-LF, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldFQM
Z-3035-2024Class IIMedline Convenience kits labeled as: ADMIT KIT PILLOW BOX, Pack Number DYKA1389MEDLINE INDUSTRIES, LP - NorthfieldFPA
Z-3034-2024Class IIMedline Convenience kits labeled as: 1) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldFMH
Z-3033-2024Class IIMedline Convenience kits labeled as: 1) SYRINGE CNTRL 10ML RED L/L LP , Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldFMF
Z-3032-2024Class IIMedline Convenience kits labeled as: 1) SYR CONTROL PAD 12ML L/L, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldDXT
Z-3031-2024Class IIMedline Convenience kits labeled as: 1) FILTER-.8 MICRON, Pack Number 2008; 2) ANES...MEDLINE INDUSTRIES, LP - NorthfieldCAH
Z-3030-2024Class IIMedline Convenience kits labeled as: 1) STEREOTACTIC BREAST BIOPSY TRA, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldPXP
Z-3029-2024Class IIMedline Convenience kits labeled as: 1) INFECTION DRIVELINE MANAGEMENT KIT, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldPXO
Z-3028-2024Class IIMedline Convenience kits labeled as: 1) KIT GENERAL CLOSURE , Pack Number DYKMBNDL200A...MEDLINE INDUSTRIES, LP - NorthfieldPKD
Z-3027-2024Class IIMedline Convenience kits labeled as: 1) 6" FEMORAL ARTERIAL LINE KIT- ICU, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldOXQ
Z-3026-2024Class IIMedline Convenience kits labeled as: KIT,ER SUTURE #1, Pack Number DYNDS1130AMEDLINE INDUSTRIES, LP - NorthfieldOVN
Z-3025-2024Class IIMedline Convenience kits labeled as: 1) MINOR BASIC PACK-LF, Pack Number DYNJ0281516M...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-3024-2024Class IIMedline Convenience kits labeled as: 1) PREP TRAY, Pack Number DYNDA1540; 2) STERILE...MEDLINE INDUSTRIES, LP - NorthfieldOJU
Z-3023-2024Class IIMedline Convenience kits labeled as: 1) CENTRAL LINE CDS, Pack Number CDS930092U ; 2)...MEDLINE INDUSTRIES, LP - NorthfieldMCY
Z-3022-2024Class IIMedline Convenience kits labeled as: SCS-LF, DYNJ902314DMEDLINE INDUSTRIES, LP - NorthfieldLRW
Z-3021-2024Class IIMedline Convenience kits labeled as: 1) ECMO INSERTION BUNDLE W/O CANNULA, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldLRS
Z-3020-2024Class IIMedline Convenience kits labeled as: 1) PRESSURE TUBING B.I., Pack Number 81239; 2)...MEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-3019-2024Class IIMedline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-399025L ; 2)...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-3018-2024Class IIMedline Convenience kits labeled as: 1) GER ARTH BASIN PK RFID-LF , Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldKDD
Z-3017-2024Class IIMedline Convenience kits labeled as: MUNCY PACK, Pack Number DYNJ03097DMEDLINE INDUSTRIES, LP - NorthfieldGEI
Z-3016-2024Class IIMedline Convenience kits labeled as: 1) CHEST EXPLORATION CDS , Pack Number CDS920066K...MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-3015-2024Class IIMedline Convenience kits labeled as: 1) PSP - VAMC LONG BEACH, Pack Number 146255; 2)...MEDLINE INDUSTRIES, LP - NorthfieldFSM
Z-3014-2024Class IIMedline Convenience kits labeled as: PARACERVICAL PUDENDAL BLOCK TR, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldFSH
Z-3013-2024Class IIMedline Convenience kits labeled as: 1) CYSTO PACK, Pack Number DYNJ42742D...MEDLINE INDUSTRIES, LP - NorthfieldEYN
Z-3012-2024Class IIMedline Convenience kits labeled as: 1) GB GENERAL ENDO , Pack Number CDS984155G ; 2)...MEDLINE INDUSTRIES, LP - NorthfieldPPB
Z-3011-2024Class IIMedline Convenience kits labeled as: 1) DIALYSIS CATH ACCESS KIT, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldPEV
Z-3010-2024Class IIMedline Convenience kits labeled as: 1) CVC INSERTION PACK, Pack Number CVI4720A ; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOHR
Z-3009-2024Class IIMedline Convenience kits labeled as: 1) GYN ENDOSCOPY KIT , Pack Number CDS981309O...MEDLINE INDUSTRIES, LP - NorthfieldNWU
Z-3008-2024Class IIMedline Convenience kits labeled as: PUH ESOPHAGECTOMY CDS, Pack Number CDS984309IMEDLINE INDUSTRIES, LP - NorthfieldKNT
Z-3007-2024Class IIMedline Convenience kits labeled as: 1) VENOUS ACCESS TRAY, Pack Number CVI4830A; 2)...MEDLINE INDUSTRIES, LP - NorthfieldFKG
Z-3006-2024Class IIMedline Convenience kits labeled as: 1) COMPREHENSIVE PROCEDURE PACK, Pack Number 7791...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-3005-2024Class IIMedline Convenience kits labeled as: 1) URETEROSCOPY CDS SC-LF, Pack Number CDS983922F...MEDLINE INDUSTRIES, LP - NorthfieldFCM
Z-3004-2024Class IIMedline Convenience kits labeled as: 1) FETOSCOPY CDS-LF, Pack Number CDS840215O ; 2)...MEDLINE INDUSTRIES, LP - NorthfieldFCH
Z-3003-2024Class IIMedline Convenience kits labeled as: 1) NHP BREAST BIOPSY PACK, Pack Number DYNJ17400B...MEDLINE INDUSTRIES, LP - NorthfieldFCG
Z-3002-2024Class IIMedline Convenience kits labeled as: 1) HEAD & NECK TRAY, Pack Number AM310B ; 2) HEAD...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-3001-2024Class IIMedline Convenience kits labeled as: 1) ZALE STEREOTACTIC CDS , Pack Number CDS983173G...MEDLINE INDUSTRIES, LP - NorthfieldMMO
Z-3000-2024Class IIMedline Convenience kits labeled as: TONSIL & ADENOID PACK, Pack Number DYNJ43427CMEDLINE INDUSTRIES, LP - NorthfieldKCB
Z-2999-2024Class IIMedline Convenience kits labeled as: 1) OSTEOTOMY ORAL PROCEDURE, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldOFX
Z-2998-2024Class IIMedline Convenience kits labeled as: 1) BIOPSY PROCEDURE PACK, Pack Number 00-400162J...MEDLINE INDUSTRIES, LP - NorthfieldOFG
Z-2997-2024Class IIMedline Convenience kits labeled as: 1) PUNCTURE TRAY , Pack Number 00-401649G ; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-2996-2024Class IIMedline Convenience kits labeled as: 1) DIALYSIS CATHETER INSERTION KIT, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldOFD
Z-2995-2024Class IIMedline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-2994-2024Class IIMedline Convenience kits labeled as: KIT VASCULAR IVC FILTER PLACEM, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldOEW
Z-2993-2024Class IIMedline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number...MEDLINE INDUSTRIES, LP - NorthfieldLDF
Z-2992-2024Class IIMedline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J...MEDLINE INDUSTRIES, LP - NorthfieldLDF
Z-2991-2024Class IIMedline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223MEDLINE INDUSTRIES, LP - NorthfieldLDF