RegWardenFDA facility compliance records
Facility

MAQUET (SUZHOU) CO., LTD

7 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2012: 2 recalls; 2017: 1 recalls; 2018: 2 recalls; 2025: 1 recalls; 2026: 1 recalls2’12’13’14’15’161’172’18’19’20’21’22’23’241’251’26
  • Recalls (7)

Devices registered here (1)

  • Table And Attachments, Operating-Room
    Product code BWN (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4950

Recalls & enforcement

  • Class IIOngoing2026-08-07
    The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.
  • Class IIOngoing2025-07-14
    Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could prevent the device from performing as intended. If the issue occurs, the operating table i…
  • Class IITerminated2018-06-14
    Certain VOLISTA StandOP Surgical Lights have been identified as having a potential light head detachment issue. Improper assembly of the bracket that connects the light head to the axle fork could result in the light head bracket breaking, causing the light head to detach from th…
  • Class IITerminated2018-04-19
    Potential keypad failure on VOLISTA StandOP Surgical Lights.
  • Class IITerminated2017-05-22
    55 kits were distributed after their expiration date of September 2015.
  • Class IITerminated2012-11-02
    There is a potential issue with the screw tension of the extension device 1433.62A1 used with the YUNO table.
  • Class IITerminated2012-05-29
    Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.

Related

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

Cite this record

RegWarden. “MAQUET (SUZHOU) CO., LTD (FEI 3007417753) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007417753-maquet-suzhou-co-ltd/

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