Class IIReported 2026-02-11

Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;

Reason for Recall

Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor

Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors Ven. bubble sensor defective or Ven. bubble sensor disconnected on the connected medical device. These errors can occur temporarily when the connecting cable is moved or permanently if the connection is fully compromised.

Recall Number

Z-1300-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2026-01-09

Reported

2026-02-11

Distribution

Worldwide Distribution: US (Nationwide) and OUS (International) to countries of: Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, El Salvador, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Korea, Republic of (South Korea), Latvia, Lithuania, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, United States, Uruguay, Uzbekistan, and Vietnam

Code Info

Model Number: 701055720; UDI-DI: 04037691816432; Serial Numbers: All units impacted;

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.