HemosIL SynthAFax — Class III medical device recall Z-0938-2026
Ongoing recall by Instrumentation Laboratory, reported 2025-12-24, distributed in AR, CA, CO, FL, IL, IN, NY. Recalled lots were manufactured with double the amount of preservative concentration.
| Recall number | Z-0938-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Instrumentation Laboratory, Bedford, MA, United States |
| Recall initiated | 2025-11-18 |
| Classified | 2025-12-17 |
| Reported by FDA | 2025-12-24 |
| Distributed | AR, CA, CO, FL, IL, IN, NY |
| Quantity | 4,506 units |
| UPC / GTIN / UDI-DI | 08426950087649 |
| Lot numbers | N0452249 |
| Model numbers | 0020007400 |
Product
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Reason for recall
Recalled lots were manufactured with double the amount of preservative concentration.
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-0938-2026. 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.