Recall Z-2554-2026— IPG Medical Corporation

Name: FDA recall Z-2554-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-05

Class II · Ongoing

Class II FDA medical device recall by IPG Medical Corporation, initiated 2026-05-05. It names one FDA 510(k) clearance: K232568. Product: Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.. Reason: Software anomaly that causes a false display of error code 5018..

Recalling firm: IPG Medical Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-05-05
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K232568 — IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and AccessoriesIpg Medical Corporation·cleared 2024-03-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.

Reason for recall

Software anomaly that causes a false display of error code 5018.

Data sourced from openFDA. This site is unofficial and independent of the FDA.