Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Colpassist Vaginal Positioning Device - Product Usage: intended for use Recalled by Boston Scientific Corporation Due to Potential for pinholes (sterile barrier breach) on the...
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
Colpassist Vaginal Positioning Device - Product Usage: intended for use in general gynecological surgery to assist in the positioning and manipulation of the vagina during the procedure. Material No. M0068318210
Quantity: 4,549 WW
Why Was This Recalled?
Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
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