Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ProACT Implantation Instrument Set Recalled by Uromedica Inc. Due to Potential issue with the manufacture and inspection of...
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 Uromedica Inc. directly.
Affected Products
ProACT Implantation Instrument Set, is a reusable, steam sterilizable surgical instrument set consisting of a U-Channel Sheath through which the Pro ACT balloon implant is introduced.
Quantity: 11 tool sets
Why Was This Recalled?
Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Uromedica Inc.
Uromedica 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