DEMO No Needle Corrugated Carton 40 U/D — Class II medical device recall Z-0197-2020
Terminated recall by Valeritas, Incorporated, reported 2019-11-06, distributed nationwide. There is a potential for "No Needle Demo Units" to contain a needle.
| Recall number | Z-0197-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Valeritas, Incorporated, Marlborough, MA, United States |
| Recall initiated | 2019-07-03 |
| Classified | 2019-10-26 |
| Reported by FDA | 2019-11-06 |
| Terminated | 2020-06-24 |
| Distributed | Nationwide (US) |
| Quantity | 21,714 devices |
| UPC / GTIN / UDI-DI | 10385609020015 |
| Lot numbers | DM418011, DM418012, DM418013, DM418014, DM418015, DM418016, DM418017, DM418031, DM418033, DM418037 |
| Model numbers | 2260-01 |
Product
DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
Reason for recall
There is a potential for "No Needle Demo Units" to contain a 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-0197-2020. 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.