Recall Z-3224-2026— Maquet SAS

Name: FDA recall Z-3224-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-07

Class II · Ongoing

Class II FDA medical device recall by Maquet SAS, initiated 2026-08-07. It names one FDA 510(k) clearance: K070442. Product: PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;. Reason: The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury..

Recalling firm: Maquet SAS
Classification: Class II
Status: Ongoing
Initiated: 2026-08-07
Firm location: Orleans Cedex 2, France

510(k) clearances named in this recall

1 on FDA's record

K070442 — POWERLED SURGICAL LIGHT SYSTEMMaquet S.A.·cleared 2007-03-16

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

PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;

Reason for recall

The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.

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