Maquet Medical Systems USA: Medical Device Recall in 2023 - (Recall #: Z-1656-2023)

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-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 701067859

Product Classification:

Class II

Date Initiated: May 18, 2023

Date Posted: June 7, 2023

Recall Number: Z-1656-2023

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: 24,250 (US)

Code Information:

Model Item No. UDI-DI HMOD 70000-USA 701067840 4058863019000 BEQ-HMOD70000-USA 701067859 4058863019024

Distribution Pattern:

Nationwide domestic distribution

Voluntary or Mandated:

Voluntary: Firm initiated