Z-1892-2026Class II

Medline Industries, LP

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-04-29

Distribution

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

Firm state

Product quantity

270,311 total

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Documentation & Change Control

Reason for recall

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

Product description

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ENSEMBLE GYNECO SCOPIE-LF DYNJ53744B LAVH GRH-LF DYNJ41792G

Code / lot info

DYNJ53744B UDI-DI 10193489761689 (EA) 40193489761680 (CS) LOT 24ABS765 DYNJ41792G UDI-DI 10195327547127 (EA) 40195327547128 (CS) LOT 24ABT556

Other recalls SPEQ maps to Documentation & Change Control

2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class IIFayus Inc.2026-07-22Class ID'Dioses Fruit Pops, Inc.2026-07-22Class ID'Dioses Fruit Pops, Inc.

See all Documentation & Change Control recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.