—#218994

Product

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

FDA product code: FMF — Syringe, Piston
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K851090
Affected lot / code info: UDI/DI 10884521013414 (each), 20884521013411 (box), 30884521013418 (case), Lot Numbers: 531164X, 531162X

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Cardinal Health 200, LLC
Address: 3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.

Timeline

Recall initiated: 2026-02-27
Posted by FDA: 2026-04-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #218994. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.