MHRA Warns Against Infant Gas-Relief Catheters

The UK's Medicines and Healthcare products Regulatory Agency has told healthcare professionals, parents, and carers to stop using rectal catheters sold as gas and colic relievers in babies, for any reason. The Device Safety Information notice, DSI/2026/008, issued 18 August, is a blunt instruction: stop using the devices immediately, and dispose of any unused stock. The products are single-use plastic tubes sold over the counter, without a prescription or clinician sign-off, aimed at soothing an infant's gas, colic, or constipation — and MHRA says there is not enough evidence they work, while their use carries a real risk of masking a more serious condition.

An unregulated-feeling product that is still a medical device

Rectal catheters marketed as gas and colic relievers occupy an unusual space in the UK device market: they are sold like a consumer wellness product — no prescription, no pharmacist consultation, available online and on shop shelves — but they are still medical devices, subject to MHRA's oversight. That gap between how a product is sold and how it is regulated is precisely why a Device Safety Information notice, rather than a manufacturer-issued recall, is the tool MHRA reached for here: the notice reaches parents and carers directly, not just the supply chain, because the people making the purchase decision are rarely the people who would see a recall notice aimed at retailers.

The clinical concern is what the device hides, not just what it does

MHRA's stated rationale has two parts. First, an evidence gap: the agency says there is not enough clinical evidence that these devices work as intended to relieve gas, colic, or constipation in infants. Second, and more serious, a masking risk: because the devices can temporarily relieve symptoms such as gas without addressing what is causing them, their use could delay diagnosis of a serious underlying gastrointestinal condition, including bowel obstruction or volvulus — a twisting of the intestine that is a surgical emergency. A parent who sees a symptom improve after using the device has less reason to seek medical attention, even if the underlying cause is one that needs urgent care. That is the kind of harm that does not show up in a typical device malfunction report, because the device is not malfunctioning; it is working as marketed, and that is the problem.

What happens next

MHRA's notice directs healthcare professionals to dispose of any unused devices in stock, to advise parents and carers not to use products they have already purchased and to dispose of them, and to refer to NICE guidance when managing colic and constipation in infants going forward — a redirection toward established, evidence-based pediatric management rather than an over-the-counter device. Anyone who has had a problem with the devices, or suspects an adverse effect in a child who used one, is asked to report it through the MHRA's Yellow Card scheme, the same reporting channel used for medicine and device safety signals across the UK. The notice does not set a compliance deadline in the way a field safety corrective action might; the instruction is to stop now.