FDA recall Z-1884-2026

Medline Industries, LP · Class II · device

Product

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B ANGIO PHC DYNJ37485C C.I.C.N. ANGIO PACK DYNJ53064B FHT P NEURO PACK DYNJ39931D NEURO ARTERIOGRAM PACK-LF DYNJ0948060F NEURO KIT NAM0003 NEURO PACK DYNJ61542D NEURO RADIOLOGY PACK DYNJ59903B NEURO TRAY DYNJ84872A PK, CATH LAB-ANGIO DYNJ44027F QVH IR NEURO PACK DYNJ62176

Reason for recall

Unapproved design changes to the products outside of the 510(k) clearance.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Panama, Barbados.

Key facts

Status: Ongoing
Initiation date: 2026-02-27
Report date: 2026-04-29
Voluntary/Mandated: Voluntary: Firm initiated
Location: Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1884-2026