Cardinal Health Monoject — Class I medical device recall Z-0852-2024
Ongoing recall by Cardinal Health 200, LLC, reported 2024-02-14, distributed nationwide. Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Ca
| Recall number | Z-0852-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2023-12-28 |
| Classified | 2024-02-02 |
| Reported by FDA | 2024-02-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10192253033519, 20192253033516, 50192253033517 |
| Lot numbers | 221201, 221202, 230201, 230202, 230203, 230204, 230205, 230206, 230207, 230208, 230209, 230210, 230211, 230212, 230213, 230214, 230215, 230216, 230217, 230218, 230219, 230601, 230602, 230603, 230701, 230702, 230703, 230704, 230705, 230706, 230707 |
| Model numbers | 1180300777 |
Product
Cardinal Health Monoject, 3 mL Syringe Luer-Lock Tip Soft Pack, REF 1180300777
Reason for recall
Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
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-0852-2024. 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.