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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85782

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 02, 2020
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Baxter Healthcare Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-2474-2020
Recall number
Z-2474-2020
Initiated
June 02, 2020
Classification
Class II
Status
Ongoing
Quantity
60 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
firmware issue

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

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.