Sophysa: Medical Device Recall in 2026 - (Recall #: Z-1029-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.

Product Description:

The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor

Product Classification:

Class II

Date Initiated: November 17, 2025

Date Posted: January 14, 2026

Recall Number: Z-1029-2026

Event ID: 98073

Reason for Recall:

Customer complaints of Pressio monitor rebooting.

Status: Ongoing

Product Quantity: 105 units

Code Information:

UDI/DI 03760124132076, All monitors

Distribution Pattern:

US Nationwide distribution in the states of AZ, WI, TX, OR, CA, OK, ID, FL, NJ.

Voluntary or Mandated:

Voluntary: Firm initiated