Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Flow Coupler Monitor Recalled by Baxter Healthcare Corporation Due to A firmware issue may cause the GEM1020M-2 Flow...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Baxter Healthcare Corporation directly.
Affected Products
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Quantity: 60 units
Why Was This Recalled?
A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.
Where Was This Sold?
This product was distributed to 19 states: AZ, CA, FL, GA, IN, LA, MD, MA, MI, MN, MS, NY, PA, SC, TX, VA, WA, WI, DC
About Baxter Healthcare Corporation
Baxter Healthcare Corporation has 401 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report