Maquet Medical Systems USA: Medical Device Recall in 2023 - (Recall #: Z-1635-2023)

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:

BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859

Product Classification:

Class II

Date Initiated: May 18, 2023

Date Posted: June 7, 2023

Recall Number: Z-1635-2023

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: 15,880 (US)

Code Information:

UDI-DI: 04058863019024 All lots

Distribution Pattern:

Domestic distribution nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated