Z-0235-2024Class II

Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP

Name: Z-0235-2024 Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
Creator: Pulmonx, Corp.
Published: 2023-08-31
License: https://open.fda.gov/license/

PULMONX, Corp. / initiated 2023-08-31 / Open, Classified / root cause: labeling and UDI

FDA source

Pulmonx, Corp. began a recall of Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP on 2023-08-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0235-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-31
Posted: 2023-11-06
Recalling firm: PULMONX, Corp.
Product: Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
Product code: NJK Valve, Pulmonary
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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
Product codes and lots: UDI: (01)00811907030423(10)506590V70(17)241208, Lot: 506590-V7.0

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0235-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0235-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-15	2023-11-06

Product code NJK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)