Maquet Medical Systems USA: Medical Device Recall in 2024 - (Recall #: Z-1076-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.

Product Classification:

Class II

Date Initiated: January 16, 2024

Date Posted: February 21, 2024

Recall Number: Z-1076-2024

Event ID: 93849

Reason for Recall:

The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.

Status: Ongoing

Product Quantity: 16520 worldwide; 6657 US

Code Information:

UDI-DI 04058863076355 Lots 3000301222, 3000319782, 3000327602 ***Added 3/21/24*** 3000333098, 3000352360, 3000357174

Distribution Pattern:

Worldwide - US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated