Maquet Critical Care AB: Medical Device Recall in 2025 - (Recall #: Z-2013-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Servo-u Ventilator System. Model Number: 6688600.

Product Classification:

Class I

Date Initiated: May 30, 2025

Date Posted: July 9, 2025

Recall Number: Z-2013-2025

Event ID: 97032

Reason for Recall:

Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.

Status: Ongoing

Product Quantity: 874 units

Code Information:

Model Number: 6688600. UDI-DI: 07325710001042. All software versions.

Distribution Pattern:

US Nationwide distribution and Puerto Rico. No international distribution.

Voluntary or Mandated:

Voluntary: Firm initiated