Maquet Medical Systems USA: Medical Device Recall in 2023 - (Recall #: Z-1637-2023)

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. 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-1637-2023

Event ID: 92003

Reason for Recall:

1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

Status: Ongoing

Product Quantity: 0 (US)

Code Information:

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

Distribution Pattern:

Domestic distribution nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated