Portex 8503Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10351688431257), received between Feb 11, 2022 and Feb 11, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Alarm System” (1 report).

3 other recalls cover devices cleared under the same FDA submission (K014115); 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 16, 2026.

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.

• MalfunctionFeb 11, 2022Device Alarm System; Device Alarm System

  ADDITIONAL INFORMATION RECEIVED VIA EMAIL STATING THAT THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13515588 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K014115. One submission often covers many models, so check the product and lot details in each record.

• Z-0809-03 · Nov 15, 2002 · Terminated
  Portex 1st Response Adult Manual Resuscitators Ref: 8500P
• Z-0808-03 · Nov 15, 2002 · Terminated
  Portex 1st Response Adult Manual Resuscitators Ref: 8506P
• Z-0810-03 · Nov 15, 2002 · Terminated
  Portex 1st Response Adult Manual Resuscitators Ref: 8503P