FDA recall Z-1889-2026

Product

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes E P DRAPE PACK-LF DYNJ0373061J

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-1889-2026