Class 2 Medicines : Norgine Pharmaceuticals Limited, Pedmarqsi 80
OFFICIAL-SOURCE RECALL · UNITED KINGDOM
Allurion Gastric Balloon: Updated safety information the risks of Recall: In rare instances, the Allurion
Use the identifiers printed on your item to determine whether this recall may affect the product you own.
CountryUnited KingdomPublishedMay 27, 2026Last updatedMay 27, 2026Official source last checkedSeptember 9, 2026 at 1:48 PM UTC
CHECK THE ITEM YOU OWN
Is your product affected?
- Brand
- See official notice
- Product
- Allurion Gastric Balloon: Updated safety information due to the risks of gastric outlet obstruction, small bowel obstruction and gastric perforation (DSI/2026/004)
- Manufacturer
- See official notice
The barcode may identify the product type, while the recall may apply only to certain lots, dates or variants. Check all identifiers listed in the official recall.
Why this product was recalled
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.
Hazard
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.
What consumers should do
for Healthcare Professionals: remain vigilant and inform patients of the signs and symptoms of gastric outlet obstruction, small bowel obstruction and gastric perforation associated with the Allurion Gastric Balloon act promptly to prevent serious complications, including early referral or review for symptomatic patients familiarise yourself with the new safety information and materials as described in FSN-01-2026 a Patient Information Card should be completed at the initial appointment and given to the patient at the time of device placement essential product and safety information can be accessed in the Physician Guidance Document. This document is available through the Allurion mobile app, the QR code on the Patient Information Card or the link in Table 1 below ensure any device that has not performed as intended and/or is involved in an adverse event is returned to Allurion Technologies Inc. for evaluation. Please report details of the event to Allurion Technologies Inc. at FSN@allurion.com and the MHRA via the Yellow Card Scheme Advice for Healthcare Professionals to Provide to Patients: seek medical attention immediately if you experience symptoms such as severe or persistent
Official recall notice
Allurion Gastric Balloon: Updated safety information due to the risks of gastric outlet obstruction, small bowel obstruction and gastric perforation (DSI/2026/004)
Agency: Medicines and Healthcare products Regulatory Agency
Official publication date: May 27, 2026
Read the official UK_MHRA recall notice →SCAN ONCE. KEEP WATCHING.
Keep an eye on the products at home.
Scan food and household product barcodes, save your items and get notified when a future recall may match.
