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

FDA Recall #Z-2620-2025 — Class II — July 15, 2025

Recall #Z-2620-2025 Date: July 15, 2025 Classification: Class II Status: Ongoing

Product Description

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.

Recalling Firm

Stryker Communications — Flower Mound, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

40

Distribution

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

Code Information

UDI-DI: 07613327296167 and 07613327651317 REF/Serial Numbers: CH00000001/7000010116, 7000010117, 7000010118, 7000010119, 7000010120, 7000010121, 7000010122, 7000010123, 7000010124, 7000010125, 7000010141, 7000010142, 7000010177, 7000010178, 7000010148, 7000010149, 7000010157, 7000010137, 7000010175, 7000010176, 7000010145, 7000010146, 7000010147, 7000010309, 7000010305, 7000010307, 7000010296, 7000010143, 7000010150, 7000010151, 7000010155. P60034/1000022, 1000023, 1000024, 1000016, 1000017, 1000018, 1000019, 1000020, 1000021

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated