Microbore Extension Set with 0 — Class I medical device recall Z-2176-2025
Ongoing recall by B BRAUN MEDICAL INC, reported 2025-08-13, distributed in AZ, CA, CO, CT, FL, GA, HI, IL…. Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, t
| Recall number | Z-2176-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B BRAUN MEDICAL INC, Allentown, PA, United States |
| Recall initiated | 2025-07-09 |
| Classified | 2025-08-06 |
| Reported by FDA | 2025-08-13 |
| Distributed | AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WY |
| Countries outside the US | CA |
| Quantity | 34,825 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04046964189166, 04046964189173 |
| Lot numbers | 0061742452, 0061747379, 0061767411, 0061780914, 0061803499, 0061806173, 0061822333, 0061836578, 0061849109, 0061850836, 0061899902, 0061936119, 0061936368, 0061936369, 0061940584 |
| Model numbers | V6215 |
Product
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.
Reason for recall
Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air vent, which is common to air eliminating filters.
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-2176-2025. 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.