VACUETTE SAFELINK — Class II medical device recall Z-0802-2025
Ongoing recall by Greiner Bio-One GmbH, reported 2025-01-15, distributed nationwide. The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching u
| Recall number | Z-0802-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Greiner Bio-One GmbH, Kremsmunster, Austria |
| Recall initiated | 2024-11-19 |
| Classified | 2025-01-03 |
| Reported by FDA | 2025-01-15 |
| Distributed | Nationwide (US) |
| Quantity | 188,800 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 19120049207487 |
| Lot numbers | 270215, A240338Q |
| Model numbers | 450210 |
Product
VACUETTE SAFELINK, REF: 450210
Reason for recall
The VACUETTE SAFELINK Holder with male luer lock may leak blood due to the protective rubber sleeve bunching up and not retracting when using the device.
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-0802-2025. 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.