FDA Device recall Z-0566-2026
Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
- FDA Device
- Class II
- ongoing
- Published 2025-11-26
On 2025-11-26 the FDA classified a Class II recall of Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503 by Asp Global, citing due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0566-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-26 |
| Published | 2025-11-26 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Asp Global |
| Distribution | US |
Product
Mixing Fleas for SAFE-T-FILL Blood Gas Capillaries, Model 07 9503
Reason
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Identifiers
| code_info | Model Number: 07 9503 GTIN (Inner Pack): 30643351000360 UDI-DI: 10643351000366 All Lots produced from 01FEB2023 to…Model Number: 07 9503 GTIN (Inner Pack): 30643351000360 UDI-DI: 10643351000366 All Lots produced from 01FEB2023 to 28FEB2025: 22B4465, 22E4465, 22I4072, 23B4158, 23C4345, 23F4176, 23H4109, 23I4060, 24D4021, 24E4130, 24E4131 |
|---|
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-0566-2026%22
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