Recall Z-1688-2026— Stryker Communications

Name: FDA recall Z-1688-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-23

Class II · Ongoing

Class II FDA medical device recall by Stryker Communications, initiated 2026-02-23. It names one FDA 510(k) clearance: K120392. Product: Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001. Reason: Surgical light assembly may not adequate support the weight of the ceiling cover..

Recalling firm: Stryker Communications
Classification: Class II
Status: Ongoing
Initiated: 2026-02-23
Firm location: Flower Mound, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K120392 — CHROMOPHARE F 628 AND F 528Berchtold GmbH & Co. KG·cleared 2012-02-16

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

Stryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001

Reason for recall

Surgical light assembly may not adequate support the weight of the ceiling cover.

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