Allurion Gastric Balloon: Updated safety information due to the risks of gastric outlet obstruction, small bowel obstruction and gastric perforation (DSI/2026/004)
UKAllurion Gastric Balloon: Updated safety information due to the risks of gastric outlet obstruction, small bowel obstruction and gastric perforation (DSI/2026/004)
Recalling Firm: MHRA
Grund für den Rückruf / Gefahr
TranslatedIn 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 gas...
Produktbeschreibung & Identifikation
TranslatedIn 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.
Betroffene Produkte
TranslatedAllurion Gastric Balloon: Updated safety information due to the risks of gastric outlet obstruction, small bowel obstruction and gastric perforation (DSI/2026/004)
Additional Source Details
| Field | Value |
|---|---|
| Guid | tag:www.gov.uk,2005:/drug-device-alerts/allurion-gastric-balloon-updated-safety-information-due-to-the-risks-of-gastric-outlet-obstruction-small-bowel-obstruction-and-gastric-perforation-dsi-slash-2026-slash-004 |
| Link | https://www.gov.uk/drug-device-alerts/allurion-gastric-balloon-updated-safety-information-due-to-the-risks-of-gastric-outlet-obstruction-small-bowel-obstruction-and-gastric-perforation-dsi-slash-2026-slash-004 |
| Pub Date | 2026-05-27T14:21:45+01:00 |
| Extracted category | devices |
Consumer Action Protocol: What You Should Do Immediately
Safety StepsInspect the NDC code, batch number, or control number on your medicine bottle or blister packaging to confirm whether your unit is included.
Do not abruptly stop critical prescribed medication without physician advice. Contact your dispensing pharmacist immediately for a safe alternative.
Under statutory consumer protection rules, consumers are entitled to a full refund, certified replacement, or free repair kit without needing the original sales receipt.
If you suffered an injury, illness, or property damage from this product, file an official incident report with regulatory authorities (issuing safety agency).
Your Legal Rights as a Consumer
Recalls are legally binding corrective safety actions overseen by statutory government bodies. Recalling entities are legally prohibited from charging consumers for official safety remedies. If a retailer or dealership refuses your recall remedy, notify the issuing regulatory agency immediately.
Frequently Asked Questions About This Recall
FAQ GuideQ1:What should I do immediately if I own or bought Allurion Gastric Balloon: Updated safety information due to the risks of gastric outlet obstruction, small bowel obst...?
Check the lot number and NDC on your prescription label. For essential medications, consult your doctor or dispensing pharmacist immediately before abruptly stopping your dose.
Q2:Can I get a full refund or free repair for this recall?
Yes. Recalling manufacturers and retail merchants are required under consumer protection regulations to offer a statutory remedy—typically a full refund, certified repair kit, or replacement unit.
Q3:Do I need my original sales receipt to claim a remedy or refund?
In most recall cases, no receipt is required. Because safety recalls are matters of public health and statutory compliance, retailers and manufacturers routinely issue refunds, store credit, or replacement kits upon presentation of the affected product or lot code.
Q4:Where can I verify official information for this safety alert?
This safety alert is aggregated directly from official regulatory agency records (Government Safety Authority). You can click the 'Official Agency Alert' link on this page to view the primary government notice and contact the manufacturer directly.
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Übersicht
- Rückrufendes UnternehmenMHRA
- RisikostufeMedical Device Alert
- DistributionUnited Kingdom
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🚨 SAFETY ALERT: MHRA - Allurion Gastric Balloon: Updated safety information due to the risks of gastric outlet obstruction, small bowel obstruction and gastric perforation (DSI/2026/004) Check if your household is affected: https://therecallfile.com/de/recalls/allurion-gastric-balloon-updated-safety-information-due-to-the-risks-o/UK-MHRA-allurion-gastric-balloon-updated-safety-information-due-to-the-risks-of-gastric-outlet-obstruction-small-bowel-obstruction-and-gastric-perforation-dsi-slash-2026-slash-004
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