DRG:HYBRiD-XL Insulin — Class II medical device recall Z-0921-2025
Ongoing recall by DRG International, Inc., reported 2025-01-22, distributed nationwide. The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument usin
| Recall number | Z-0921-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DRG International, Inc., Springfield, NJ, United States |
| Recall initiated | 2024-10-07 |
| Classified | 2025-01-15 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CZ, RO |
| Quantity | 10 units |
| Reason classes | potency, specification failure |
| UPC / GTIN / UDI-DI | 04048474053616 |
| Lot numbers | 429K084-1 |
| Model numbers | HYE-5361 |
Product
DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361
Reason for recall
The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of specification (failed Control High) which causes a delay in 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-0921-2025. 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.