FDA recall, , Moderate risk
Thuvera Laser Console
The Thuvera Laser Console has a software anomaly that causes a false display of error code 5018.
Summary by Recall Canary from the FDA notice
What happened
IPG Medical Corporation of Marlborough, Massachusetts, recalled the Thuvera Laser Console, Software Version 2.2, a portable Thulium Fiber Laser, because of a software anomaly that causes a false display of error code 5018. The recall began May 5, 2026, and was added to the FDA's Enforcement Report on June 24, 2026. The product was distributed in Massachusetts, with 198 units affected.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
- UDI-DI
- 00810071230226
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the state of Massachusetts.
- Company
- IPG Medical CorporationMarlborough, Massachusetts
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99064
- Recall number
- Z-2554-2026
- Quantity recalled
- 198 units
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
