FDA Device recall Z-0567-2026
SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004
- FDA Device
- Class II
- ongoing
- Published 2025-11-26
On 2025-11-26 the FDA classified a Class II recall of SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004 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-0567-2026 |
| 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
SAFE-T-FILL Micro Collection Tube Extender, Model 09 1004
Reason
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Identifiers
| code_info | Model Number: 09 1004 GTIN (Inner Pack): 30643351000223 UDI-DI: 10643351000229 All Lots produced from 01AUG2020 to 2…Model Number: 09 1004 GTIN (Inner Pack): 30643351000223 UDI-DI: 10643351000229 All Lots produced from 01AUG2020 to 28FEB2025: 21D4585, 22E4059, 22J4037, 23I4016, 23J4029 |
|---|
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-0567-2026%22
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