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 Medical, Inc Due to Due to an anomaly in the packaging process...
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 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: 856 units
Why Was This Recalled?
Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. The breach may or may not be easily seen.
Where Was This Sold?
US Distribution.
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