Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Gyrus ACMI Falope-Ring Dilator Recalled by Gyrus Medical, Inc Due to Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have...
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 Gyrus Medical, Inc directly.
Affected Products
Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30). The Falope-Ring Band Contraceptive Tubal Occlusion Device (TOD) consists of a cylindrical radiopaque silicone band that occludes the lumen of the Fallopian tube when placed over a looped segment of the tube. The FRB-30 (used with the reusable applicators) consists of one reusable Falope-Ring Guide, an instruction manual and 30 procedure kits. Each kit is provided sterile and includes one dilator and two Falope Bands.
Quantity: 507 units
Why Was This Recalled?
Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have been sold as a stand-alone non-sterile component. The dilator is intended to assist placement of the Falope-Ring band on the reusable Falope applicator.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Gyrus Medical, Inc
Gyrus Medical, Inc has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report