FDA Device recall Z-2474-2020
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
- FDA Device
- Class II
- ongoing
- Published 2020-07-08
On 2020-07-08 the FDA classified a Class II recall of Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only by Baxter Healthcare, citing A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2474-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-06-02 |
| Published | 2020-07-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Baxter Healthcare |
| Distribution | AZ, CA, DC, FL, GA, IN, LA, MA, MD, MI, MN, MS, NY, PA, SC, TX, VA, WA, WI |
Product
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
Reason
A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connection is not established.
Identifiers
| code_info | Product Code: 5156-00000-011, All Serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2474-2020%22
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