Design Options¿ / Epidural anesthesia kit — Class II medical device recall Z-2003-2023
Ongoing recall by B. Braun Medical, Inc., reported 2023-07-05, distributed nationwide. Kits were assembled with the incorrect Filter Straw.
| Recall number | Z-2003-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical, Inc., Allentown, PA, United States |
| Recall initiated | 2023-06-05 |
| Classified | 2023-06-23 |
| Reported by FDA | 2023-07-05 |
| Distributed | Nationwide (US) |
| Quantity | 3,560 units |
| UPC / GTIN / UDI-DI | 04046955214440, 04046955596102, 04046955596140, 04046964950254 |
| Lot numbers | 0061853751, 0061854949, 0061855133, 0061855598 |
| Model numbers | 552116, 552155, 552177, 552179 |
Product
Design Options¿ / Epidural anesthesia kit (10 count carton)
Reason for recall
Kits were assembled with the incorrect Filter Straw.
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-2003-2023. 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.