Data Foundry

Medical device recalls 2025

Medline Convenience kits used for various procedures: 1) LINE… — Class II medical device recall Z-1593-2025

Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-04-23, distributed nationwide. There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile co

Recall numberZ-1593-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmMEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States
Recall initiated2025-03-03
Classified2025-04-17
Reported by FDA2025-04-23
DistributedNationwide (US)
Countries outside the USCA, MX, PA
Quantity3,808 units
Reason classessterility
UPC / GTIN / UDI-DI10193489298499, 10193489646191, 10193489678284, 10193489769227, 10195327054908, 10195327055790, 10195327352356, 10195327463779, 10195327614652, 10198459071485, 10198459085512, 10198459111006, 10198459169410, 10889942043927, 10889942553884, 40193489298490, 40193489646192, 40193489678285, 40193489769228, 40195327054909, 40195327055791, 40195327352357, 40195327463770, 40195327614653, 40198459071486 and 5 more
Lot numbers24IBS279, 24JBM452, 24JBO094, 24JBT077, 24JBT886, 24JBT947, 24JBW632, 24KBB128, 24KBB902, 24KBC476, 24KBD388, 24KBD507, 24KBE301, 24KBE666, 24KBH524, 24KBJ200
Model numbersCDS980379J, DYNDH1904, DYNJ15652M, DYNJ20803D, DYNJ24529M, DYNJ41682C, DYNJ44949C, DYNJ55170F, DYNJ55356A, DYNJ65827, DYNJ67899A, DYNJ80643, DYNJ81267A, DYNJ82437A, PHS902533005

Product

Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK, Model Number: DYNJ44949C; 2) PICC LINE INSERTION BJC-LF, Model Number: DYNJ41682C; 3) SUPERFICIAL VENOUS PROCEDURE, Model Number: DYNJ81267A; 4) ILR INSERTION-REMOVAL PACK, Model Number: DYNJ82437A; 5) C LINE INSERTION CDS, Model Number: CDS980379J; 6) BSHR PICC LINE-LF, Model Number: DYNJ24529M; 7) ENSEMBLE POWER PICC-HEJ-LF, Model Number: DYNJ65827; 8) PICC LINE PACK, Model Number: DYNJ55170F; 9) LINE INSERTION PACK, Model Number: DYNJ44949C; 10) RFA PACK, Model Number: DYNJ67899A; 11) KIT CENTRAL LINE INSERTION-LF, Model Number: PHS902533005; 12) INFANT LUMBAR PUNCTURE TRAY, Model Number: DYNDH1904; 13) PICC PACK-LF, Model Number: DYNJ55356A; 14) GENERAL TRAY, Model Number: DYNJ15652M; 15) CVR ENDOVENOUS PACK, Model Number: DYNJ80643; 16) LINE INSERTION TRAY, Model Number: DYNJ20803D

Reason for recall

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1593-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.