CLASS II ONGOING Device recall · Reported 15 Nov 2023 · FDA Enforcement Report
Zephyr Endobronchial Valve (EBV) 5.5-LP recalled by Pulmonx
Pulmonx is recalling Zephyr Endobronchial Valve (EBV) 5.5-LP, distributed in 22 states. The recall was initiated on 31 Aug 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0235-2024
- FDA event ID
- 93179
- Recalling firm
- Pulmonx, Redwood City, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Aug 2023
- FDA classified
- 6 Nov 2023
- Reported
- 15 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 31 Aug 2023 | Recall initiated by company | |
| 6 Nov 2023 | Classified by FDA | +67 days |
| 15 Nov 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
Where it was distributed
US: TN, WV, AR, PA, VA, NC, IL, IA, MA, NY, NJ, WA, CO, OR, MI, FL, OH, TX, OK, AZ, NV, WI
ArkansasArizonaColoradoFloridaIowaIllinoisMassachusettsMichiganNorth CarolinaNew JerseyNevadaNew YorkOhioOklahomaOregonPennsylvaniaTennesseeTexasVirginiaWashington
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI: (01)00811907030423(10)506590V70(17)241208, Lot: 506590-V7.0
Where was it sold?
US: TN, WV, AR, PA, VA, NC, IL, IA, MA, NY, NJ, WA, CO, OR, MI, FL, OH, TX, OK, AZ, NV, WI
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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