Pulmonx, Corp. 2023-11-15 Health serious FDA
Health · FDA · Recall #FDA-Z-0235-2024
Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP Recall
Issued November 15, 2023 · Pulmonx, Corp.
In November 2023, Pulmonx, Corp. recalled the Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Pulmonx, Corp. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Pulmonx, Corp.
- Category
- Health
- Recall date
- November 15, 2023
- Units affected
- Not reported
- Sold at
- US: TN, WV, AR, PA, VA, NC, IL, IA, MA, NY, NJ, WA, CO, OR, MI, FL, OH, TX, OK, AZ, NV, WI
- Recall number
- FDA-Z-0235-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Pulmonx, Corp. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.