CLASS II Device recall · Reported 27 Aug 2014 · FDA Enforcement Report
Gyrus ACMI Falope-Ring Dilator recalled by Gyrus Medical
Gyrus Medical is recalling Gyrus ACMI Falope-Ring Dilator, distributed nationwide in the US. The recall was initiated on 8 Jul 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2269-2014
- FDA event ID
- 68768
- Recalling firm
- Gyrus Medical, Osseo, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Jul 2014
- FDA classified
- 19 Aug 2014
- Reported
- 27 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 8 Jul 2014 | Recall initiated by company | |
| 19 Aug 2014 | Classified by FDA | +42 days |
| 27 Aug 2014 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide AlabamaArkansasCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIowaIllinoisIndianaLouisianaMarylandMichiganMinnesotaMississippiNew HampshireOhioOregonPennsylvania
Questions about this recall
Is Gyrus ACMI Falope-Ring Dilator recalled?
Yes. Gyrus Medical recalled Gyrus ACMI Falope-Ring Dilator on 8 Jul 2014. The recall is Class II and its status is Terminated. Recall number Z-2269-2014.
Why was it 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.
Which lots are affected?
catalog No.: 000878-4, not lot controlled.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Gyrus Medical
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Gyrus Acmi recalled by Gyrus Medical | Gyrus Medical | Sterility | Nationwide |
| Device | CLASS II | Gyrus ACMI Disposable Falope-Ring Band Applicator Kits recalled | Gyrus Medical | Sterility | MN |
| Device | CLASS II | Gyrus Acmi recalled by Gyrus Medical | Gyrus Medical | Sterility | Nationwide |
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