Z-1882-2026Class 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 FACE/RHINOPLASTY PACK DYNJ80343C PLASTIC HEAD-NECK PACK DYNJ86639

Code / lot info

DYNJ80343C UDI-DI 10195327507299 (EA) 40195327507290 (CS) LOT 24ABO127 DYNJ86639 UDI-DI 10195327661922 (EA) 40195327661923 (CS) LOT 24FBM972

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.