FDA Device recall Z-0938-2026
HemosIL SynthAFax
- FDA Device
- Class III
- ongoing
- Published 2025-12-24
On 2025-12-24 the FDA classified a Class III recall of HemosIL SynthAFax by Instrumentation Laboratory, citing recalled lots were manufactured with double the amount of preservative concentration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0938-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-11-18 |
| Published | 2025-12-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Instrumentation Laboratory |
| Distribution | AR, CA, CO, DE, FL, IL, IN, NY |
Product
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Reason
Recalled lots were manufactured with double the amount of preservative concentration.
Identifiers
| code_info | Part No. 0020007400; UDI: 08426950087649; Lot No. (Exp. Date) N0542231(2026-06-30), N0250088(2027-04-30, N0452249 (2027-06-30). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0938-2026%22
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