YelloPort Elite - Laparoscopic Port Access System EA10NHRecalls & reported problems

Summary

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

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K190592); 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. Jan 20, 2022Class IIOpen, Classified

   Laparoscopic devices have a sterile symbol included on labels but devices are non-sterile.

   Z-1852-2022 · Root cause: Process control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K190592. One submission often covers many models, so check the product and lot details in each record.

• Z-1396-2022 · Jun 2, 2022 · Completed
  YelloPort Elite Universal Seal. For use in laparoscopic procedures.