Covidien MONOJECT Standard Hypodermic Needle — Class II medical device recall Z-0424-2021
Terminated recall by Cardinal Health 200, LLC, reported 2020-11-11, distributed nationwide. Potential for the needle to detach from the cartridge after the bottom of the cartridge is twisted and removed
| Recall number | Z-0424-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Mansfield, MA, United States |
| Recall initiated | 2020-09-25 |
| Classified | 2020-11-05 |
| Reported by FDA | 2020-11-11 |
| Terminated | 2023-10-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Quantity | 519,676 units |
| Reason classes | device malfunction |
| Lot numbers | 011144, 011145 |
| Model numbers | 8881250248 |
Product
Covidien MONOJECT Standard Hypodermic Needle, Polypropylene Hub 22 G x 3/4". Intended use to facilitate activities such as: withdrawal of medication from a container, aspiration of fluid from a patient, injection of medication into a patient, and transfer fluids Item Code: 8881250248
Reason for recall
Potential for the needle to detach from the cartridge after the bottom of the cartridge is twisted and removed. If the needle is not securely seated, the needle can fall out of the sheath and cause the unused needle to project out of the cartridge, and result in a needle stick/puncture from the clean/unused needle
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-0424-2021. 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.