Allurion Gastric Balloon Recall: Updated Safety Information Issued
Areazine synthesizes this MHRA medicine alert directly from MHRA's official public data feed. See our methodology for full source attribution and refresh cadence.
The Allurion Gastric Balloon has been linked to rare risks of gastric outlet obstruction, small bowel obstruction and gastric perforation when it does not transit as intended.
What this MHRA medicine alert tells you, and what most readers miss
This notice was issued by MHRA on June 5, 2026 and geographically references National. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - Medicine Alerts - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, mhra, MedicalDevice.
What Happened
In rare instances, the Allurion Gastric Balloon has not transited through the stomach or bowel as intended, leading to complications such as gastric outlet obstruction, small bowel obstruction and gastric perforation.
Which Products Are Affected
Allurion Gastric Balloon (DSI/2026/004).
What You Should Do
Patients and healthcare professionals should follow the updated safety information provided in the MHRA alert.
Why This Matters
The device has been associated with serious complications including gastric perforation in rare cases.
Source
Original source: MHRA Official Notice ↗
Related Medicine Alerts
All Medicine Alerts →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this MHRA medicine alert: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (825 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to June 5, 2026.
Frequently Asked Questions
Common questions about this MHRA medicine alert.