SPUR® Adult Resuscitator 520611061Recalls & reported problems

Ambu A/S · SPUR II Adult Bag Res, Med Mask, PEEP, Exp Filter · Class 2

All models of SPUR Adult Resuscitator (4)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05707480154074), received between Feb 2, 2026 and Feb 2, 2026 — classified as 1 malfunction.

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Patient problems

Low Oxygen Saturation1

Recent adverse event reports

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

MalfunctionFeb 2, 2026
DURING VENTILATION WITH NURSING AND ANESTHESIA, OXYGEN SATURATIONS CONTINUED TO DECLINE WHEN IT WAS NOTICED THAT AMBU FACE MASK WAS ATTACHED TO WHERE THE PEEP [POSITIVE END EXPIRATORY PRESSURE] VALVE ATTACHES.
Patient problems: Low Oxygen Saturation
MAUDE report 24230208 ↗

Device details

UDI-DI	`05707480154074`
Brand	SPUR® Adult Resuscitator
Model	520611061
Company	Ambu A/S
Product code	BTM · Ventilator, emergency, manual (resuscitator)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jan 30, 2026

Device type (GMDN): Pulmonary resuscitator, manual, single-use

A non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.

Other Ventilator, emergency, manual (resuscitator) devices

Ventlab AF5140MB
Ventlab, LLC · Ventilator, Emergency, Manual (Resuscitator)
1 recall8 reports
Curaplex AF2000
Bound Tree Medical, LLC · Ventilator, emergency, manual (resuscitator)
1 recall6 reports
Ventlab AF5140MBP
Ventlab, LLC · Ventilator, Emergency, Manual (Resuscitator)
1 recall5 reports
Ventlab AF2140MBP
Ventlab, LLC · Ventilator, Emergency, Manual (Resuscitator)
1 recall2 reports
Ventlab AF5142MBP
Ventlab, LLC · Ventilator, Emergency, Manual (Resuscitator)
1 recall2 reports
Ventlab SS3200MB-MMC
Ventlab, LLC · Ventilator, Emergency, Manual (Resuscitator)
1 recall1 report
Ventlab AF2142MC-3
Ventlab, LLC · Ventilator, Emergency, Manual (Resuscitator)
1 recall1 report
Ventlab AF1140MB-P
Ventlab, LLC · Ventilator, Emergency, Manual (Resuscitator)
1 recall1 report

All Ventilator, emergency, manual (resuscitator) devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page