CLASS II Device recall · Reported 3 Dec 2014 · FDA Enforcement Report
Disposable Falope-Ring Band Applicator Kits recalled
Gyrus Acmi is recalling Disposable Falope-Ring Band Applicator Kits, distributed nationwide in the US. The recall was initiated on 21 Oct 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-0419-2015
- FDA event ID
- 69584
- Recalling firm
- Gyrus Acmi, Southborough, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Oct 2014
- FDA classified
- 21 Nov 2014
- Reported
- 3 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 21 Oct 2014 | Recall initiated by company | |
| 21 Nov 2014 | Classified by FDA | +31 days |
| 3 Dec 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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).
Where it was distributed
Worldwide distribution. US Nationwide, Canada, Vietnam, and Europe
Questions about this recall
Why was it 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.
Which lots are affected?
All lots
Where was it sold?
Worldwide distribution. US Nationwide, Canada, Vietnam, and Europe
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 26 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 Acmi
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Olympus Diego Elite Console Mdcons recalled by Gyrus ACMI | Gyrus Acmi | Other | Nationwide |
| Device | CLASS II | Diego Elite Turbinate Blades Bipolar Blade straight recalled | Gyrus Acmi | Other | Nationwide |
| Device | CLASS II | Diego Elite Malleable Standard Monopolar Blades Product recalled | Gyrus Acmi | Other | Nationwide |
| Device | CLASS II | Diego Elite Turbinate Blades Bipolar Blade curved recalled by Gyrus ACMI | Gyrus Acmi | Other | Nationwide |
| Device | CLASS II | Diego Elite Turbinate Blades Bipolar Blade curved recalled by Gyrus ACMI | Gyrus Acmi | Other | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |