The Medicines and Healthcare products Regulatory Agency has issued a Device Safety Information notice advising parents and carers not to use rectal catheters sold for personal use on infants. The products are commonly marketed as gas and colic relievers and can be bought online or in shops without a prescription. For households, the instruction is immediate rather than conditional. The MHRA says products already purchased for infant use should be disposed of, and parents should not recommend them to others.
The regulator's position follows a review of the available evidence alongside expert clinical advice. According to the MHRA, there is not enough evidence to show that these devices work as intended when used for colic, constipation or trapped wind in babies. That finding matters because the intervention is based not on a confirmed pattern of severe harm, but on a judgement that claimed benefit has not been established to a standard that would justify exposing infants to avoidable risk.
The notice is narrowly drawn. It does not apply to rectal catheters used by healthcare professionals in specialist clinical contexts, including conditions such as Hirschsprung's, meconium ileus and gastroschisis. In policy terms, the MHRA is separating supervised clinical use from consumer use in the home. That distinction reduces the risk that a public warning to parents is read as a blanket statement about all rectal catheter use in paediatric care.
Although the MHRA says there have been no confirmed reports of serious injury, it states that the safety profile and clinical benefit of these products remain uncertain. The regulator and its clinical advisers identified two main concerns: first, that use at home could make it harder to spot an underlying condition that needs medical assessment; and second, that insertion could injure the infant's bottom. The latter risk is not presented as minor. The MHRA specifically refers to the possibility of tearing or perforating the inside of the bottom, outcomes that could carry serious consequences even if they have not been confirmed in reported cases to date.
Dr Alison Cave, the MHRA's Chief Safety Officer, said digestive discomfort can be distressing for babies and families, but the evidence base does not support the safety and effectiveness of these devices in infants. The regulator's advice is that parents and carers should seek guidance from a healthcare professional and follow NHS advice if they are worried about a baby's symptoms. That shifts the practical response away from retail devices and towards assessment, particularly where constipation, trapped wind or prolonged unsettled behaviour might be masking a different problem.
For retailers, online marketplaces and anyone involved in product recommendation, the notice creates a clear regulatory signal: infant use should not be presented as a routine or endorsed response to colic or gas-related discomfort. For parents, the message is simpler still: do not use these products in babies, dispose of any already bought, and seek clinical advice where symptoms persist or worsen. The MHRA has also asked for suspected problems to be reported through the Yellow Card scheme. As an executive agency of the Department of Health and Social Care, the regulator is using the reporting route to build the evidence base while drawing a firm precautionary line around consumer use in infants.