RegWardenFDA facility compliance records
Recall

Class II — Pulmonx, Corp.

Recalling firmPulmonx, Corp.
Registered facilityPULMONX, Corp. (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonEndobronchial implant devices may have been labeled with a shortened expiration date but they can be used until the correct expiration date: 08 December 2024.
ProductZephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
Quantity144
DistributionUS: TN, WV, AR, PA, VA, NC, IL, IA, MA, NY, NJ, WA, CO, OR, MI, FL, OH, TX, OK, AZ, NV, WI
Initiated2023-08-31
Classified2023-11-06
Recall numberZ-0235-2024
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Pulmonx, Corp. (Z-0235-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93179/

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