Monoject Standard Hypodermic Needle — Class II medical device recall Z-2038-2019
Completed recall by Cardinal Health 200, LLC, reported 2019-07-31, distributed nationwide. Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of th
| Recall number | Z-2038-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Mansfield, MA, United States |
| Recall initiated | 2019-04-30 |
| Classified | 2019-07-23 |
| Reported by FDA | 2019-07-31 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| Lot numbers | 904212, 905612, 907002 |
| Model numbers | 8881200037 |
Product
Monoject Standard Hypodermic Needle, 16 G x 1-1/2" Item code: 8881200037
Reason for recall
Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product
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-2038-2019. 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.