Flow Coupler Monitor — Class II medical device recall Z-2474-2020
Ongoing recall by Baxter Healthcare Corporation, reported 2020-07-08, distributed in AZ, CA, DC, FL, GA, IN, LA, MA…. A firmware issue may cause the GEM1020M-2 Flow Coupler Monitor to intermittently shut down when a WiFi connect
| Recall number | Z-2474-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2020-06-02 |
| Classified | 2020-06-30 |
| Reported by FDA | 2020-07-08 |
| Distributed | AZ, CA, DC, FL, GA, IN, LA, MA, MD, MI, MN, MS, NY, PA, SC, TX, VA, WA, WI |
| Quantity | 60 units |
| Reason classes | software |
Product
Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2474-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.