Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O Recalled by Boston Scientific Corporation Due to Mislabeling
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 Boston Scientific Corporation directly.
Affected Products
AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
Quantity: 52 units
Why Was This Recalled?
Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Boston Scientific Corporation
Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report