Cardinal Health Monoject Tuberculin Syringe — Class II medical device recall Z-1768-2026
Ongoing recall by Cardinal Health 200, LLC, reported 2026-04-08, distributed nationwide. The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Produc
| Recall number | Z-1768-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2026-02-27 |
| Classified | 2026-04-02 |
| Reported by FDA | 2026-04-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 198,900 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10884521013414, 20884521013411, 30884521013418 |
| Lot numbers | 531162X, 531164X |
| Model numbers | 1180100777 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1768-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.