GEM FLOW COUPLER MONITOR GEM1020M-2Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (K191252); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jun 19, 2023Class IIOpen, Classified

   An issue was identified where the LCD monitor display may not indicate the correct active channel. The issue occurs when the monitor is turned on using battery power, and channel B was selected as the last active channel prior to powering down.

   Z-2208-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Dec 28, 2020Class IIOpen, Classified

   Potential for the battery to lose its ability to be recharged.

   Z-0939-2021 · Root cause: Software design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K191252. One submission often covers many models, so check the product and lot details in each record.

• Z-2474-2020 · Jun 2, 2020 · Open, Classified
  Flow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx Only