Gyrus ACMI Falope-Ring Dilator, item 000878-4. The… recallZ-2269-2014 · Gyrus Medical, Inc · initiated Jul 8, 2014
Class II Terminated All recalls posted in August 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Gyrus Medical, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Packaging process control
What the company is doing
Olympus sent a "Medical Device Recall" letter dated July 7, 2014 to affected customers. The letter was addressed to Surgery Department & Risk Management Department. The letter described the product being recalled, problem and actions to be take. Consignees were advised to immediately cease further use of any affected product and to remove and discard it. Customers were to fax the completed questionnaire to 484-896-7128. For questions contact Laura Storms at 484-896-5688 or at [email protected]
Recall details
- Recall number
- Z-2269-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 8, 2014
- Posted by the FDA
- Aug 19, 2014
- Recalling firm
- Gyrus Medical, Inc
- Quantity
- 507 units
- Product code
- KNH
- FDA submissions
- P870076
- Distribution
- Worldwide - US Nationwide Distribution in the states of AL, AR, CA, CO, CT, DE, FL, GA, IA, IL, IN, LA, MD, MI, ,MN, MS, NH, HY, OH,OR, PA, TN TX, UT, VA, WA, WI,and WV. and the country of CANADA.
Product description
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.
Code information (models, lots, serial numbers)
catalog No.: 000878-4, not lot controlled.
Other devices under the same FDA submission
3 devices cleared under P870076 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- FALOPE-RING FRB-30Gyrus ACMI, LLC · Device, Occlusion, Tubal, Contraceptive4 reports
- Falope Ring 005280-901Gyrus ACMI, LLC · Device, Occlusion, Tubal, Contraceptive3 reports
- Falope-Ring 006889-901Gyrus ACMI, LLC · Device, Occlusion, Tubal, Contraceptive1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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