Maquet Medical Systems USA: Medical Device Recall in 2023 - (Recall #: Z-1657-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 701067891 HMO 51000-USA 701067895

Product Classification:

Class II

Date Initiated: May 18, 2023

Date Posted: June 7, 2023

Recall Number: Z-1657-2023

Event ID: 92006

Reason for Recall:

Product packaging may exhibit small pinholes which may not be visible to the unaided eye, compromising the sterile barrier of the packaging. Exposure to non-sterile device may result in inflammation, infection, sepsis, and ischemia.

Status: Ongoing

Product Quantity: 1,784 (US)

Code Information:

Model Item no. UDI-DI BEQ-HMO 50000-USA 701067905 4058863019079 HMO 50000-USA 701067891 4058863019055 HMO 51000-USA 701067895 4058863019185 All lots

Distribution Pattern:

Nationwide domestic distribution

Voluntary or Mandated:

Voluntary: Firm initiated