Baxter Healthcare Corporation Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Brand
Baxter Healthcare Corporation
Lot Codes / Batch Numbers
Product Code: 5156-00000-011, All Serial numbers
Products Sold
Product Code: 5156-00000-011, All Serial numbers
Baxter Healthcare Corporation is recalling Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only due to A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.
Recommended Action
Per FDA guidance
Synovis Micro Companies Alliance (MCA), Inc., a subsidiary of Baxter International Inc., sent a notification to healthcare providers dated, June 2, 2020 titled, "Urgent Medical Device Recall". The notification was sent to the user level for the GEM1020M-2 Flow Coupler Monitor due to a firmware issue which may cause the monitor to intermittently shut down when a WiFi connection is not established. If a shutdown occurs, the monitor can be manually powered back on and will resume normal operation. Synovis is requesting the return of the monitors to perform a firmware upgrade to resolve the issue. Customers should contact Synovis to arrange for product return for the firmware upgrade and replacement of the product. Customers should complete the Baxter customer reply form and return it to Baxter by scanning and e-mailing it to fca@baxter.com, even if customers do not have any inventory. Customers should return the response form promptly. If customers have distributed the product to other facilities or departments within the institution, a copy of the communication should be forwarded to them. Questions regarding the communication, contact Synovis at 800-510-3318 or 205-941-0111, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, FL, GA, IN, LA, MD, MA, MI, MN, MS, NY, PA, SC, TX, VA, WA, WI, DC
Page updated: Jan 10, 2026