Maquet Cardiopulmonary Gmbh: Medical Device Recall in 2025 - (Recall #: Z-2193-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.

Product Classification:

Class II

Date Initiated: June 27, 2025

Date Posted: August 6, 2025

Recall Number: Z-2193-2025

Event ID: 97097

Reason for Recall:

Device does not comply with the labeling requirements of international standard IEC 60601-1.

Status: Ongoing

Product Quantity: 7,754 units

Code Information:

Model No. 701033599; UDI: 4037691257860.

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Australia, New Zealand, Canada, Hong Kong, India, Israel, Japan, Singapore, South Korea, Taiwan, Thailand, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain, Sweden, Turkey, Reunion, Romania, Russian Federation, Switzerland, Ukraine, United Kingdom, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Mexico, Paraguay, Peru, Uruguay, Bahrain, Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Oman, Pakistan, Qatar, Saudi Arabia, South Africa, United Arab Emirates, Yemen.

Voluntary or Mandated:

Voluntary: Firm initiated