YelloPort Elite - Laparoscopic Port Access System ET1207503Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05051986012438), received between Jan 17, 2022 and Jan 17, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).

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 ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2022Device Markings/Labelling Problem

  AFTER RECEIPT, THE CUSTOMER FOUND THAT THE DEVICE WAS LABELLED "STERILE R", WITH A DUE DATE, AND DISPOSABLE SYMBOL ON THE LABEL DESPITE NON STERILE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13265044 ↗

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.