MHRA warns parents to stop using infant rectal 'gas' catheters and dispose of unused devices

The U.K. medicines and devices regulator has told parents, caregivers and healthcare professionals to stop using all rectal catheters marketed as gas or colic relievers in infants and to throw away any unused devices, in an immediate safety alert issued Tuesday.

In Device Safety Information DSI/2026/008, dated Aug. 18, the Medicines and Healthcare products Regulatory Agency, or MHRA, said: “Do not use rectal catheters in infants, including for colic, gas-related discomfort or constipation. Stop using these products immediately and dispose of any unused devices.” The notice applies to all such products, not a named brand.

The MHRA described the devices as single-use, hollow plastic tubes with a stopper that are inserted into an infant’s rectum and are commonly used by parents and caregivers in an attempt to relieve gas-related discomfort. The agency said the products are sold online and in stores “without a prescription or oversight from a healthcare professional,” making the warning particularly relevant for families using them at home rather than in clinical settings.

The regulator said it does not recommend the products because there is insufficient clinical evidence that they work and because the potential risks are unknown. The MHRA said its review was prompted by concerns raised by stakeholders and healthcare professionals, and that its findings were considered by the independent Interim Devices Working Group, which also raised concerns about possible risks and the lack of evidence of benefit.

Among the risks cited by the agency were possible physical harm, including rectal trauma, perforation, bleeding and pain, especially when the devices are used by people who are not healthcare professionals. The MHRA also warned that using the products could mask symptoms and delay diagnosis of serious gastrointestinal conditions, including bowel obstruction and volvulus, a twisting of the intestine that can become a medical emergency. It also pointed to reports of incorrect reuse, which could increase infection risk.

At the same time, the MHRA stressed that the alert is precautionary. “The MHRA has received no reports of rectal trauma, perforation, bleeding or pain in infants related to the use of rectal catheters,” the safety notice said. Even so, the agency said “significant residual concerns remain,” based on the absence of evidence of benefit and the possibility of harm.

The notice does not amount to a formal recall, and the MHRA said there is no advice for distributors linked to this safety information. But it is an official warning from the U.K. regulator for medicines and medical devices, aimed both at clinicians and at the public.

For healthcare professionals, the MHRA said to cease using the devices, dispose of unused stock, remain alert to the possibility that their use could delay diagnosis of serious gastrointestinal conditions and report incidents through the Yellow Card Scheme, the U.K.’s system for reporting safety concerns involving medicines and medical devices.

For parents and caregivers, the message was straightforward: do not use rectal catheters on children and dispose of any unused devices. The MHRA also pointed families to NHS guidance on colic, which emphasizes noninvasive soothing measures and says remedies are not recommended where there is no evidence they help. Anyone worried about a child’s symptoms should seek advice from a health visitor, NHS 111 or a GP, or call 999 in an emergency.