TUMARK Q — Class II medical device recall Z-0410-2018
Terminated recall by Somatex Medical Technologies GmbH, reported 2018-01-31, distributed in NY. There is a potential risk of puncture to the packaging material which can compromise the devices sterility, ma
| Recall number | Z-0410-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Somatex Medical Technologies GmbH, Teltow, N/A, Germany |
| Recall initiated | 2017-05-22 |
| Classified | 2018-01-24 |
| Reported by FDA | 2018-01-31 |
| Terminated | 2018-08-30 |
| Distributed | NY |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 04250195603081 |
| Lot numbers | 47883, 47910, 47911 |
| Model numbers | 271500 |
Product
TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
Reason for recall
There is a potential risk of puncture to the packaging material which can compromise the devices sterility, making it non-sterile.
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-0410-2018. 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.