Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ReShape Integrated Dual Balloon System Recalled by Reshape Medical Inc Due to ReShape Medical is recalling the Integrated Dual Balloon...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Reshape Medical Inc directly.
Affected Products
ReShape Integrated Dual Balloon System, Gen 1, Model No. 01-0013-001, Catalog No. RSM110 product Usage: The ReShape Integrated Dual Balloon System is indicated for weight reduction when used in conjunction with diet and exercise, in obese patients with a Body Mass Index (BMI) of 30 40 kg/m2 and one or more obesityrelated comorbid conditions. It is indicated for use in adult patients who have failed weight reduction with diet and exercise alone.
Quantity: 114 units
Why Was This Recalled?
ReShape Medical is recalling the Integrated Dual Balloon System Gen 1 due to the potential leak of distillation fluid during balloon inflation.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Reshape Medical Inc
Reshape Medical Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report