Zephyr Endobronchial Valve — Class II medical device recall Z-0235-2024
Ongoing recall by Pulmonx, Corp., reported 2023-11-15, distributed in AR, AZ, CO, FL, IA, IL, MA, MI…. Endobronchial implant devices may have been labeled with a shortened expiration date but they can be used unti
| Recall number | Z-0235-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pulmonx, Corp., Redwood City, CA, United States |
| Recall initiated | 2023-08-31 |
| Classified | 2023-11-06 |
| Reported by FDA | 2023-11-15 |
| Distributed | AR, AZ, CO, FL, IA, IL, MA, MI, NC, NJ, NV, NY, OH, OK, OR, PA, TN, TX, VA, WA, WI, WV |
| Quantity | 144 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00811907030423 |
| Lot numbers | 506590-V7.0 |
| Model numbers | EBV-TS-5.5-LP |
Product
Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
Reason for recall
Endobronchial implant devices may have been labeled with a shortened expiration date but they can be used until the correct expiration date: 08 December 2024.
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-0235-2024. 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.