Maquet Medical Systems USA: Medical Device Recall in 2023 - (Recall #: Z-1660-2023)

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 Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701070416

Product Classification:

Class II

Date Initiated: May 18, 2023

Date Posted: June 7, 2023

Recall Number: Z-1660-2023

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: 0 (US)

Code Information:

Model Item No. UDI HMO 10000-USA 701070412 4058863154473 HMO 11000-USA 701070416 4058863154558 All lots

Distribution Pattern:

Nationwide domestic distribution

Voluntary or Mandated:

Voluntary: Firm initiated