Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and Recalled by Gyrus Acmi, Incorporated Due to All packages of Falope Ring Band Applicator kits...
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 Acmi, Incorporated directly.
Affected Products
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).
Quantity: 74,792 units
Why Was This Recalled?
All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead to patient infection.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Gyrus Acmi, Incorporated
Gyrus Acmi, Incorporated has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report