Device safety informationMHRA
Counterfeits and unbranded copies of LifeVac anti-choking devices may fail safety warning over a malfunction
Anti-choking devices are intended to alleviate choking incidents after Basic Life Support protocols have been attempted and failed. There are numerous counterfeit and unbranded anti-choking devices being sold in the UK online which do not have a valid UKCA or CE mark and may pose a significant risk of worsening choking if used. These devices should not be used in the event of a choking emergency and should be disposed of once identified as counterfeit or non-compliant.
What to do now
Counterfeits and unbranded copies of LifeVac anti-choking devices may stop working properly or fail during use.
- If you use this device at home, do not stop treatment without speaking to the team who supplied it.
- Compare the details on the device or its box with the list here.
- Report problems with medical devices to the MHRA Yellow Card scheme.
Why it matters. A device that fails at the wrong moment can delay treatment or cause injury.
Replacements and support
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices.
If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2024/003). Quoted as issued.
Summary
Anti-choking devices are intended to alleviate choking incidents after Basic Life Support protocols have been attempted and failed.
There are numerous counterfeit and unbranded anti-choking devices being sold in the UK online which do not have a valid UKCA or CE mark and may pose a significant risk of worsening choking if used. These devices should not be used in the event of a choking emergency and should be disposed of once identified as counterfeit or non-compliant.
The risk
Device Details Counterfeit and unbranded anti-choking devices appear similar in design to the LifeVac anti-choking device, and primarily originate from China. No genuine anti-choking devices marketed in the UK are manufactured in China, and therefore products shipped from China should be treated with significant suspicion. Image comparison between genuine and counterfeit anti-choking devices is provided further below in this document .
Advice for healthcare professionals
Actions for users and customers
Check that your anti-choking device is genuine using the provided guidance. Do not use the anti-choking device in the event of a choking emergency if you suspect that the device you have purchased is a counterfeit or unbranded copy of the legitimate LifeVac anti-choking device. This is because the device is not compliant with the UK Medical Device Regulations 2002 and therefore there is a significant risk the device may fail to work or even worsen the situation.
If you identify one or more of the above indicators of a counterfeit or unbranded anti-choking device copy, however are not certain, the MHRA would recommend contacting the legal manufacturer LifeVac Europe Ltd . The manufacturer can verify the legitimacy of the purchased product against their records of authorised distributors and product serial numbers.
The MHRA recommends that purchasers of counterfeit or unbranded anti-choking devices dispose of the device rather than returning the device to the seller due to the risk of resale.
When purchasing anti-choking devices online we advise users to exercise caution. Ensure that you purchase only from reputable sellers; be particularly vigilant for sites using fake reviews to promote their product. Users may check that the device’s manufacturer is registered with the MHRA via our public access database . The MHRA recommends you also refer to our published guidance on buying medical devices for personal use .
If you have previously used one of these counterfeit or unbranded anti-choking devices and it failed to work, please report the incident to LifeVac Europe Ltd and to the MHRA via our Yellow Card scheme website , providing information on where you purchased the device.
Actions for those working in care settings
If anti-choking devices are deployed or available for use in your care provider, you should review these devices against the information provided above in this notice to determine whether these are counterfeits or unbranded devices.
If these devices are found to be counterfeit or unbranded, the guidance in ‘actions for users and customers’ should be followed accordingly.
Actions for healthcare professionals, especially health visitors or those working with parents in the community
There are specific reporting arrangements for healthcare professionals to follow in each region. Healthcare professionals should report incidents:
in Scotland to Incident Reporting & Investigation Centre (IRIC) and their local incident recording system
Open the MHRA notice
Questions
Why has Counterfeits and unbranded copies of LifeVac anti-choking devices been recalled?
Counterfeits and unbranded copies of LifeVac anti-choking devices may stop working properly or fail during use. A device that fails at the wrong moment can delay treatment or cause injury.
How do I know if my product is affected?
The notice describes the affected product rather than listing codes. Compare the product name, pack size and where you bought it with the official notice.
What should I do now?
If you use this device at home, do not stop treatment without speaking to the team who supplied it. Compare the details on the device or its box with the list here.
Who replaces the device?
Device safety notices are mainly aimed at hospitals, clinics and suppliers, who are told how to replace, update or check affected devices. If you use the device at home, the team or company that supplied it is responsible for any replacement or correction.