FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM — Class II medical device recall Z-1930-2021
Ongoing recall by Cardinal Health Inc., reported 2021-06-30, distributed nationwide. Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 h
| Recall number | Z-1930-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health Inc., Dublin, OH, United States |
| Recall initiated | 2021-03-16 |
| Classified | 2021-06-23 |
| Reported by FDA | 2021-06-30 |
| Distributed | Nationwide (US) |
| Quantity | 8,959 kits |
| Reason classes | temperature control |
| Model numbers | 5479084 |
Product
FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
Reason for recall
Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.
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-1930-2021. 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.