SAFE-T-FILL Micro Capillary Blood Collection — Class II medical device recall Z-0546-2026
Ongoing recall by ASP Global, LLC. dba Anatomy Supply Partners, LLC., reported 2025-11-26, distributed nationwide. Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes
| Recall number | Z-0546-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ASP Global, LLC. dba Anatomy Supply Partners, LLC., Austell, GA, United States |
| Recall initiated | 2025-09-26 |
| Classified | 2025-11-19 |
| Reported by FDA | 2025-11-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 64,850 |
| UPC / GTIN / UDI-DI | 10643351000151, 30643351000155 |
| Model numbers | 7121 |
Product
SAFE-T-FILL Micro Capillary Blood Collection, 300 ¿L; Prepared with Clot Activator and Serum Separator Gel; Red Model/Catalog Number: 07 7121 Product Description: The SAFE-T-FILL Capillary Blood Collection System is a collection device used to draw capillary blood from the finger or heelstick.
Reason for recall
Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes.
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-0546-2026. 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.