Sure T — Class II medical device recall Z-1821-2015
Terminated recall by Unomedical As, reported 2015-07-01, distributed in CA, IL, MN, PA. Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of me
| Recall number | Z-1821-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Unomedical As, Roskilde, Denmark |
| Recall initiated | 2015-05-21 |
| Classified | 2015-06-19 |
| Reported by FDA | 2015-07-01 |
| Terminated | 2017-01-23 |
| Distributed | CA, IL, MN, PA |
| Countries outside the US | AE, AU, BE, BH, CA, CH, CN, DE, DK, EE, ES, FR, GB, GR, HK, HU, IL, IT, KW, LB, MY, NL, OM, SE, TR, ZA |
| Quantity | 22,976,870 units |
| Reason classes | device malfunction |
Product
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
Reason for recall
Unomedical has found that in rare cases the steel needle can break during use, interrupting the delivery of medication including insulin.
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-1821-2015. 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.