YelloPort Elite - Laparoscopic Port Access System EA512USRecalls & 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 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. Jun 2, 2022Class IICompleted

   There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.

   Z-1396-2022 · Root cause: Process change 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-1852-2022 · Jan 20, 2022 · Open, Classified
  Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.