FDA recall Z-1558-2026

Product

CLARITY II Laser System; Model No. 1110200210.

Reason for recall

Reports of devices sparking/popping and potentially burning patients.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.

Key facts

Status

Ongoing

Initiation date

2026-01-27

Report date

2026-03-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Goyang, N/A, Korea (the Republic of)

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1558-2026