Device safety informationMHRA
Rectal catheters sold for personal use (gas and colic relievers) safety warning over a malfunction
Do not use rectal catheters sold for personal use (gas and colic relievers) in infants, including for colic, gas-related discomfort or constipation. Stop using these products immediately and dispose of any unused devices.
What to do now
The MHRA has warned about a fault with Rectal catheters sold for personal use (gas and colic relievers).
- Speak to the clinic, hospital or supplier who gave you the device before changing how you use it.
- Check the model, lot or serial number against the details on this page.
- Any incident involving the device can be reported through the Yellow Card scheme.
Why it matters. A device that fails at the wrong moment can delay treatment or cause injury.
Replacements and support
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next.
Do not throw away a device you rely on until a replacement has been arranged.
From the official notice
Published by the Medicines and Healthcare products Regulatory Agency (DSI/2026/008). Quoted as issued.
Summary
Do not use rectal catheters sold for personal use (gas and colic relievers) in infants, including for colic, gas-related discomfort or constipation. Stop using these products immediately and dispose of any unused devices.
The risk
This Device Safety Information has been updated since its original publication on 18 August 2026 to reflect that the recommendations apply to rectal catheters sold for personal use, and the advice is not applicable to rectal catheters used for specialist medical treatment.
Advice for healthcare professionals
Do not use rectal catheters sold for personal use (gas and colic relievers) in infants, including for colic, gas-related discomfort or constipation. Stop using these products immediately and dispose of any unused devices. The MHRA does not recommend their use because there is insufficient clinical evidence to demonstrate effectiveness, and the potential risks associated with these products are unknown.
Please note this advice is not applicable for rectal catheters that are used for specialist medical treatment for conditions such as Hirschsprung’s, meconium ileus and gastroschisis where parents/caregivers have been trained by healthcare professionals.
Rectal catheters sold for personal use (gas and colic relievers) are single use, hollow, plastic tubes with a stopper that are inserted into the infant’s rectum (bottom) and are commonly used by parents and caregivers to attempt to provide relief from gas-related discomfort.
If parents or caregivers have any concerns about their baby, they should speak to their healthcare professional.
advise parents and caregivers not to use rectal catheters sold for personal use (gas and colic relievers) in infants, including to treat colic, gas, bloating, or constipation and dispose of any unused products
the use of these devices may delay diagnosis of serious gastrointestinal conditions, such as bowel obstruction or volvulus, by temporarily alleviating symptoms like gas without addressing the root cause
the risks of rectal trauma, perforation, bleeding or pain associated with the use of these devices in infants are unknown
please refer to the NICE Clinical Knowledge Summary for information on the management of colic in infants
report any incidents associated with the use of rectal catheters sold for personal use in infants to the MHRA via the Yellow Card Scheme or via local reporting routes. For more detailed reporting instructions please see ‘Reporting advice’ below.
do not use rectal catheters sold for personal use (gas and colic relievers) in your child, including to treat colic, gas, bloating, or constipation and dispose of any unused products
the risks of injury to the infant’s bottom (rectum), bleeding, pain or perforation (a hole in the bowel) associated with use of these devices in infants are unknown
please refer to NHS guidance for the management of colic
Advice for patients
do not use rectal catheters sold for personal use (gas and colic relievers) in your child, including to treat colic, gas, bloating, or constipation and dispose of any unused products
the risks of injury to the infant’s bottom (rectum), bleeding, pain or perforation (a hole in the bowel) associated with use of these devices in infants are unknown
please refer to NHS guidance for the management of colic
if you are concerned about your baby, it’s best to speak to your health visitor, call NHS 111, see a GP, or call 999 in an emergency
if you suspect that your child has had a side effect related to the use of rectal catheters sold for personal use (gas and colic relievers) report it to the MHRA via the Yellow Card website
Open the MHRA notice
Questions
Why has Rectal catheters sold for personal use (gas and colic relievers) been recalled?
The MHRA has warned about a fault with Rectal catheters sold for personal use (gas and colic relievers). 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?
Speak to the clinic, hospital or supplier who gave you the device before changing how you use it. Check the model, lot or serial number against the details on this page.
Who replaces the device?
Speak to the supplier, clinic or hospital that gave you the device. They will know whether yours is affected and what happens next. Do not throw away a device you rely on until a replacement has been arranged.