FDA recall Z-2620-2025

Stryker Communications · Class II · device

Product

Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034

Reason for recall

Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.

Distribution

US Nationwide distribution in the states of TX, IL, NY, UT, OR, AZ, VT, NY, IL, MN.

Key facts

Status
Ongoing
Initiation date
2025-07-15
Report date
2025-10-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Flower Mound, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2620-2025