Nova StatStrip/StatSensor Hospital Blood Glucose Meter — Class II medical device recall Z-0650-2014
Terminated recall by Nova Biomedical Corporation, reported 2014-01-15, distributed nationwide. Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage
| Recall number | Z-0650-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nova Biomedical Corporation, Waltham, MA, United States |
| Recall initiated | 2013-10-10 |
| Classified | 2014-01-09 |
| Reported by FDA | 2014-01-15 |
| Terminated | 2014-03-24 |
| Distributed | Nationwide (US) |
| Quantity | 200,000 |
| Reason classes | packaging |
Product
Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative determination of Glucose in whole blood.
Reason for recall
Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage
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-0650-2014. 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.