FDA Device recall Z-0556-2026
SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L
- FDA Device
- Class II
- ongoing
- Published 2025-11-26
On 2025-11-26 the FDA classified a Class II recall of SAFE-T-FILL MicroHematocrit Capillary Tubes, 50 ¿L 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-0556-2026 |
| 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 MicroHematocrit Capillary Tubes, 50 ¿L; Untreated, Blue Markings Model/Catalog Number: 06 0508 Product Description: A clear, plastic capillary blood collection tube
Reason
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
Identifiers
| code_info | Model Number: 06 0508 GTIN : 30643351000384 UDI-DI: 10643351000380 All Lots produced from 1AUG2020 to 28FEB2025: 2…Model Number: 06 0508 GTIN : 30643351000384 UDI-DI: 10643351000380 All Lots produced from 1AUG2020 to 28FEB2025: 21F4062, 21L4388, 22G4487, 23C4341, 23F4164, 23G4172, 23G4210, 24I4053, 24I4327, 24I4330, 24I4331, 24I4409, 24J4141, 24J4350 |
|---|
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-0556-2026%22
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