Z-1768-2026 Class II Ongoing
FDA device recall Z-1768-2026 was initiated by Cardinal Health 200, LLC on Feb 27, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 198,900 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 8, 2026
- Initiation Date
- Feb 27, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 198,900 units
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Canada.
Code Information
UDI/DI 10884521013414 (each), 20884521013411 (box), 30884521013418 (case), Lot Numbers: 531164X, 531162X
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1768-2026
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026