Baxter Healthcare Corporation: Medical Device Recall in 2020 - (Recall #: Z-2474-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only

Product Classification:

Class II

Date Initiated: June 2, 2020

Date Posted: July 8, 2020

Recall Number: Z-2474-2020

Event ID: 85782

Reason for Recall:

A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.

Status: Ongoing

Product Quantity: 60 units

Code Information:

Product Code: 5156-00000-011, All Serial numbers

Distribution Pattern:

U.S. distribution only: VA, GA, MD, PA, DC, WI, LA, MN, FL, IN, MI, AZ, TX, MS, MA, NY, SC, WI, WA, MI, CA.

Voluntary or Mandated:

Voluntary: Firm initiated