Endobronchial valve devices recalled for incorrect expiration date labeling
Pulmonx endobronchial valve devices may have been labeled with a shortened expiration date. The devices are usable until December 8, 2024.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II device recall involving a labeling error where the expiration date printed on packaging is shortened compared to the actual usable date. No illnesses, injuries, or product defect has been reported. The hazard is labeling-based rather than product-based.
Plain-English summary
Pulmonx Corporation is recalling Zephyr Endobronchial Valve (EBV) 5.5-LP devices that may have been labeled with a shortened expiration date. The affected lot is 506590-V7.0, which was distributed to healthcare facilities across 22 U.S. states.
The devices were labeled with an expiration date earlier than the actual usable date. The correct expiration date for affected units is December 8, 2024. Healthcare providers should verify the expiration dates on labels and use the correct date when determining product usability.
No illnesses or injuries related to this labeling error have been reported. Patients and healthcare providers with these devices should consult the labeling correction information provided by Pulmonx. Healthcare facilities are advised to check their inventory for lot 506590-V7.0 and update their records with the correct expiration date.
The recalled product
- Product
- Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
- Manufacturer
- Pulmonx, Corp.
- Hazard
- Affected units
- 144
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: (01)00811907030423(10)506590V70(17)241208
- Lot: 506590-V7.0
Distribution
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