Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF… recallZ-0419-2015 · Gyrus Acmi, Incorporated · initiated Oct 21, 2014
Class II Terminated All recalls posted in June 2015
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 Acmi, Incorporated 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
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.
FDA root cause category: Process control
What the company is doing
Olympus sent an Urgent Medical Device Recall letter dated October 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Olympus requires you to take the following action: I. Immediately cease any further use of any affected product you have, remove it from your inventory and quarantine it until it is shipped back to us. 2. Call your Olympus customer service representative at 1-888-524-7266 to obtain a Returned Goods Authorization so that you may return the product with no charge to you. Olympus will issue a credit t or replacement to your facility y for any returned product. 3. Please note on the enclosed questionnaire that you have received this information. 4. Fax the completed questionnaire to 484-896-7128 regardless of whether you have any affected inventory at your facility. ln addition, if you may have further distributed this product, please identify your customers, notify them at once of this product recall, and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this recall notification letter.
Recall details
- Recall number
- Z-0419-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 21, 2014
- Posted by the FDA
- Jun 26, 2015
- Recalling firm
- Gyrus Acmi, Incorporated
- Quantity
- 74,792 units
- Product code
- KNH
- FDA submissions
- P870076
- Distribution
- Worldwide distribution. US Nationwide, Canada, Vietnam, and Europe
Product description
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).
Code information (models, lots, serial numbers)
All lots
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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