FDA recall Z-1887-2026

Product

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EXTREMITY PACK DYNJ34846C HAND PACK DYNJ83218A, DYNJ85396 LAMINECTOMY DYNJ905156R MAJOR EXTREMITY DYNJ905159L, DYNJ905159M MAJOR EXTREMITY PACK DYNJ69926A PODIATRY PACK DYNJ41250B

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-1887-2026