Cardinal Health Monoject Tuberculin Syringe recall (Cardinal Health 200, LLC)
Medical deviceClass IIOngoing
Summary: Cardinal Health 200, LLC is recalling 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.
What is being recalled
Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution - US Nationwide and the country of Canada.
How to tell if yours is affected
UDI/DI 10884521013414 (each), 20884521013411 (box), 30884521013418 (case), Lot Numbers: 531164X, 531162X
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1768-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 27, 2026 |
| Reported | April 8, 2026 |
| Company | Cardinal Health 200, LLC |
| Company location | Waukegan, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 198,900 units |
More recalls from Cardinal Health 200, LLC · all medical device recalls · recalls from February 2026