Recall Z-1768-2026
Cardinal Health 200, LLC · initiated February 27, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
Codes / lots: UDI/DI 10884521013414 (each), 20884521013411 (box), 30884521013418 (case), Lot Numbers: 531164X, 531162X
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.
FDA-determined cause: Under Investigation by firm
Action taken
Cardinal Health issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 2/27/2026 via overnight mail. The notice explained the issue, potential risk to health and requested the following: "Actions Required: 1. REVIEW your inventory for the affected product codes. Location of product code and lot are shown on the label. 2. COMMUNICATE with all personnel that utilize the affected product. 3. SEGREGATE and quarantine all affected product upon review of your inventory. Affected product should not be used. Utilize return directions below to return product. 4. DISSEMINATE this notice to all departments, clinics and external campuses that handle the affected products. 5. DISTRIBUTORS please notify any customers to whom you may have distributed/forwarded affected product to about this medical device recall and share a copy of this notice. 6. RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to GMB-FieldCorrectiveAction@cardinalhealth.com, whether you have affected product or not." For questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: GMB-FieldCorrectiveAction@cardinalhealth.com or call 800-292-9332.
Details
- Recall number
- Z-1768-2026
- Initiated
- February 27, 2026
- Posted by FDA
- April 2, 2026
- Product code
- FMF – Syringe, Piston
- Quantity
- 198,900 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recalling firm
- Cardinal Health 200, LLC, Waukegan, IL