UniStrip1 — Class II medical device recall Z-0855-2015
Terminated recall by Unistrip Technologies LLC, reported 2014-12-31, distributed in FL, OH. Failure to submit a 510(k) for device labeling changes.
| Recall number | Z-0855-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Unistrip Technologies LLC, Charlotte, NC, United States |
| Recall initiated | 2014-11-20 |
| Classified | 2014-12-23 |
| Reported by FDA | 2014-12-31 |
| Terminated | 2015-05-20 |
| Distributed | FL, OH |
| Quantity | 7,175 units |
| Reason classes | labeling |
Product
UniStrip1, Blood Glucose Test Strips, 50 count box. The test strips are indicated for use by people with diabetes in their home as an aid to monitor the effectiveness of diabetes control.
Reason for recall
Failure to submit a 510(k) for device labeling changes.
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-0855-2015. 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.