Recall Z-1768-2026— Cardinal Health 200, LLC

Name: FDA recall Z-1768-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-27

Class II · Ongoing

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2026-02-27. It names one FDA 510(k) clearance: K851090. Product: Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777. Reason: 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..

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Ongoing
Initiated: 2026-02-27
Firm location: Waukegan, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K851090 — MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEESherwood Medical Co.·cleared 1985-04-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.