FDA recall, , Moderate risk
Cardinal Health Monoject Tuberculin Syringes
The outer packaging and blister pack label the product as a 1mL Luer Lock Tuberculin Syringe, but the syringes inside are U-100 Insulin syringes.
Summary by Recall Canary from the FDA notice
What happened
Cardinal Health 200, LLC of Waukegan, Illinois, began a recall on February 27, 2026, of Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock. The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe, but the syringes contained within the packages are U-100 Insulin syringes. The recall involves 198,900 units and was added to the FDA's Enforcement Report on April 2, 2026, with distribution nationwide in the US and in Canada.
The syringes were distributed worldwide, including the US nationwide and Canada.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
- UDI-DI
- 10884521013414
- 20884521013411
- 30884521013418
- Lot code
- 531164X
- 531162X
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the country of Canada.
- Company
- Cardinal Health 200, LLCWaukegan, Illinois
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98534
- Recall number
- Z-1768-2026
- Quantity recalled
- 198,900 units
All recalls from Cardinal Health 200, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
