RegWardenFDA facility compliance records
Recall

Class II — Maquet SAS

Recalling firmMAQUET (Suzhou) Co., Ltd
Registered facilityMAQUET (SUZHOU) CO., LTD (the firm's only registered facility)
ClassificationClass II
StatusOngoing
ReasonThe potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.
ProductPowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;
Quantity667
DistributionUS Nationwide distribution.
Initiated2026-08-07
Classified2026-09-18
Recall numberZ-3224-2026
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Maquet SAS (Z-3224-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99696/

Not open yet

Alerts for MAQUET (Suzhou) Co., Ltd

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.