← FDA ENFORCEMENT
Z-1768-2026Class II

Cardinal Health 200, LLC

Recalling firm
Cardinal Health 200, LLC
Product type
Device
Status
Ongoing
Report date
2026-04-08
Distribution
Worldwide distribution - US Nationwide and the country of Canada.
Firm state
IL
Product quantity
198,900 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.

Product description

Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777

Code / lot info

UDI/DI 10884521013414 (each), 20884521013411 (box), 30884521013418 (case), Lot Numbers: 531164X, 531162X

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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.