BagEasy 562048Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00709078620485), received between Jan 23, 2025 and Jan 23, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K934310); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 23, 2025Break; Material Fragmentation; Obstruction of Flow; Break; Material Fragmentation; Obstruction of Flow

  THE REPORTED ISSUE: "WHEN MY STAFF WENT TO USE THE AMBU BAG, THEY WERE UNABLE TO SQUEEZE IT. IT WAS LIKE THERE WAS AN OBSTRUCTION NOT ALLOWING THE BAG TO BE SQUEEZED. LATER STAFF SQUEEZED IT AS HARD AS THEY COULD AND HEARD A "POP." THEN THEY WERE ABLE TO SQUEEZE THE BAG NORMALLY. WHEN KRISTIE AND I TOOK THE BAG APART TO INSPECT IT WE FOUND A PLASTIC VALVE RIGHT WHERE THE DEVICE CONNECTS TO THE AIRWAY. YOU COULD TELL THE PLASTIC WAS RIPPED FROM WHERE IT POPPED WHEN THE STAFF SQUEEZED THE BAG REALLY HARD. IT APPEARS THE VALVE WAS SEALED SHUT INSTEAD OF OPENING LIKE IT SHOULD HAVE." THIS HAS BEEN DOCUMENTED AS SINGLE EVENT FOR THE DEVICE, THEREFORE ONLY ONE MDR WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21225444 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K934310. One submission often covers many models, so check the product and lot details in each record.

• Z-2333-2010 · Jun 22, 2010 · Terminated
  BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory support. It can provide positive pressure ventilation or oxygen for the s
• Z-2332-2010 · Jun 22, 2010 · Terminated
  BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory support. It can provide positive pressure ventilation or oxygen for the s