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

59,336 records, page 37 of 1187
FDA device recalls, page 37 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2095-2026Class IIMedline Convenience Kits: 1) KIT SURG ONC EXCISION BREAST, Model Number:DYKMBNDL84A; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOFG
Z-2094-2026Class IIMedline Convenience Kits: 1) PICC LINE TRAY, Model Number:00-401993O; 2) CODE CART ADULT...MEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-2093-2026Class IISee RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-2092-2026Class IIMedline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AB; 2) OR...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-2091-2026Class IIMedline Convenience Kits: 1) ANGIO PROCEDURE PACK, Model Number:00-401824AA; 2) ENDO KIT...MEDLINE INDUSTRIES, LP - NorthfieldOEQ
Z-2090-2026Class IIMedline Convenience Kits: 1) SCC RF PAIN MGMT, Model Number:DYNJ56436A; 2) SCC RF PAIN...MEDLINE INDUSTRIES, LP - NorthfieldOFT
Z-2089-2026Class IIMedline Convenience Kits: 1) ANCILLARY PACK-LF, Model Number:DYNJ0185290G; 2) OPEN HEART...MEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-1297-2026Class IIProduct Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog...OLYMPUS Corporation of the AmericasKNS
Z-1296-2026Class IIProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number...OLYMPUS Corporation of the AmericasKNS
Z-1295-2026Class IIProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number...OLYMPUS Corporation of the AmericasKNS
Z-1294-2026Class IIProduct Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number...OLYMPUS Corporation of the AmericasKNS
Z-1293-2026Class IIBrand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen...OLYMPUS Corporation of the AmericasKNS
Z-1292-2026Class IIProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number...OLYMPUS Corporation of the AmericasKNS
Z-1291-2026Class IIProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number...OLYMPUS Corporation of the AmericasKNS
Z-1290-2026Class IIProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number...OLYMPUS Corporation of the AmericasKNS
Z-1289-2026Class IIProduct Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number...OLYMPUS Corporation of the AmericasKNS
Z-1288-2026Class IIProduct Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number...OLYMPUS Corporation of the AmericasKNS
Z-1287-2026Class IIProduct Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number...OLYMPUS Corporation of the AmericasKNS
Z-1425-2026Class IIMedline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2)...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1424-2026Class IIMedline Surgical Gowns: 1) GOWN,NONRNF,L,30/CS, Model Number: DYNJP2001; 2)...MEDLINE INDUSTRIES, LP - NorthfieldFYA
Z-1423-2026Class IIMedline Surgical Drapes: 1) SHEET,DRAPE,40X58,STERILE, Model Number: DYNJP2410; 2)...MEDLINE INDUSTRIES, LP - NorthfieldPUI
Z-1422-2026Class IIMedline Convenience Kits: 1) ARTHROSCOPY CDS, Model Number: CDS984609B; 2) ARTHROSCOPY...MEDLINE INDUSTRIES, LP - NorthfieldOII
Z-1421-2026Class IIMedline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-1420-2026Class IIMedline Convenience Kits: 1) KIT OPHTHALMIC RUPTURE GLOBE, Model Number: DYKMBNDL104; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-1419-2026Class IIMedline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOKV
Z-1418-2026Class IIMedline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY...MEDLINE INDUSTRIES, LP - NorthfieldOJF
Z-1417-2026Class IIMedline Convenience Kits: 1) C-SECTION PACK, Model Number: CDS820080N; 2) C-SECTION CDS...MEDLINE INDUSTRIES, LP - NorthfieldOHM
Z-1416-2026Class IIMedline Convenience Kits: 1) KIT UROLOGY SLING, Model Number: DYKMBNDL106; 2) KIT...MEDLINE INDUSTRIES, LP - NorthfieldOHG
Z-1415-2026Class IIMedline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-1414-2026Class IIMedline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL...MEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-1413-2026Class IIMedline Convenience Kits: 1) NEURO SHUNT- CODMAN, Model Number: CDS860018G; 2) NEURO...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-1412-2026Class IIMedline Convenience Kits: 1) CHEST/BREAST-LF, Model Number: DYNJ83950MEDLINE INDUSTRIES, LP - NorthfieldPAD
Z-1411-2026Class IIMedline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035A; 2) LVAD...MEDLINE INDUSTRIES, LP - NorthfieldOXQ
Z-1410-2026Class IIMedline Convenience Kits: 1) ADMIT KIT, Model Number: DYKA1343AMEDLINE INDUSTRIES, LP - NorthfieldNSB
Z-1409-2026Class IIMedline Convenience Kits: 1) DRAPE PACK, Model Number: DYNJ35363A; 2) SICK KIDS-GENERAL...MEDLINE INDUSTRIES, LP - NorthfieldKKX
Z-1408-2026Class IIMedline Convenience Kits: 1) PPE KIT, Model Number: DYK1011945PMEDLINE INDUSTRIES, LP - NorthfieldJOL
Z-1407-2026Class IIMedline Convenience Kits: 1) KIT TRIPLE LUMEN INSERTION, Model Number: DYNDM1031AMEDLINE INDUSTRIES, LP - NorthfieldFOZ
Z-1406-2026Class IIMedline Convenience Kits: 1) DRAPE PACK-CHOICE, Model Number: DYNJ63118AMEDLINE INDUSTRIES, LP - NorthfieldFMH
Z-1405-2026Class IIMedline Convenience Kits: 1) KIT GENERAL CLOSURE, Model Number: DYKMBNDL200AMEDLINE INDUSTRIES, LP - NorthfieldPKD
Z-1404-2026Class IIMedline Convenience Kits: 1) BURN PACK, Model Number: DYNJ15668R; 2) BURN PACK-LF, Model...MEDLINE INDUSTRIES, LP - NorthfieldOJJ
Z-1403-2026Class IIMedline Convenience Kits: 1) WMC I D PACK-LF, Model Number: DYNJ50806LMEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-1402-2026Class IIMedline Convenience Kits: 1) LVAD DRIVELINE TRAY, Model Number: DM1035; 2) KIT SURG ONC...MEDLINE INDUSTRIES, LP - NorthfieldMCY
Z-1401-2026Class IIMedline Convenience Kits: 1) KIT ACES INSERT PEG, Model Number: DYKMBNDL130; 2) KIT ACES...MEDLINE INDUSTRIES, LP - NorthfieldLRS
Z-1400-2026Class IIMedline Convenience Kits: 1) TOTE ABRAMS KNEE ARTHROSCOPY, Model Number: DYKM1801B; 2)...MEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-1399-2026Class IIMedline Convenience Kits: 1) DRAWER 6-IV FLUIDS GLOVES, Model Number: ACC010326; 2)...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1398-2026Class IIMedline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK...MEDLINE INDUSTRIES, LP - NorthfieldKDD
Z-1397-2026Class IIMedline Convenience Kits: 1) PLASTIC BIN W/MISC KITS, Model Number: ACC010499; 2) KIT...MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-1396-2026Class IIMedline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI...MEDLINE INDUSTRIES, LP - NorthfieldPPB
Z-1395-2026Class IIMedline Convenience Kits: 1) MAJOR LAPAROTOMY CDS, Model Number: CDS860015U; 2) MAJOR...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-1394-2026Class IIMedline Convenience Kits: 1) CHP COCHLEAR SUPPLEMENT CDS, Model Number: CDS983069G; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOGR