Anesthesia IV Set utilized in gravity IV administration sets and pump… — Class II medical device recall Z-0609-2026
Ongoing recall by B Braun Medical Inc, reported 2025-12-03. Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and t
| Recall number | Z-0609-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B Braun Medical Inc, Bethlehem, PA, United States |
| Recall initiated | 2025-10-29 |
| Classified | 2025-11-26 |
| Reported by FDA | 2025-12-03 |
| Countries outside the US | CA, DE, GT, SG |
| Quantity | 36,552 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04046964991264, 04046964991271 |
| Model numbers | 490477 |
Product
Anesthesia IV Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. IV ADMIN SET W/15 DROPS/ML, 134 IN.; Catalog Number: 490477.
Reason for recall
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
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-0609-2026. 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.