FDA Medical Device Recalls (openFDA)
Pulmonx, Corp.: Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
- Recall number
- Z-0235-2024
- Recalling firm
- Pulmonx, Corp.
- Product
- Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
- Status
- Open, Classified
- Initiated
- 2023-08-31
- Posted
- 2023-11-06
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Error in labeling
- Action
- On 8/31/23, correction notices were emailed to customers who were asked to do the following: 1) The affected lot can be used without risk to the patient until 08 December 2024. In addition, this lot was manufactured on 2021-12-08. 2) Check your inventory and keep this letter with any remaining product of the affected lot to support the corrected manufacture and expiration date. 3) Send a response email acknowledging receipt that includes the number of affected devices remaining at your site. Customers with questions can call 650-743-6848.
- Quantity
- 144
- Distribution
- US: TN, WV, AR, PA, VA, NC, IL, IA, MA, NY, NJ, WA, CO, OR, MI, FL, OH, TX, OK, AZ, NV, WI
- Lot, serial or model codes
- UDI: (01)00811907030423(10)506590V70(17)241208, Lot: 506590-V7.0
- 510(k) numbers
- not on file
- PMA numbers
- ["P180002"]
- Product code
- NJK
- Firm FEI
- 3007797756
- Firm city
- Redwood City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28