Gyrus ACMI Disposable Falope-Ring Band Applicator Kits — Class II medical device recall Z-0419-2015
Terminated recall by Gyrus Acmi, Incorporated, reported 2014-12-03, distributed nationwide. All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging th
| Recall number | Z-0419-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gyrus Acmi, Incorporated, Southborough, MA, United States |
| Recall initiated | 2014-10-21 |
| Classified | 2014-11-21 |
| Reported by FDA | 2014-12-03 |
| Terminated | 2017-03-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, VN |
| Quantity | 74,792 units |
| Reason classes | microbial contamination, sterility |
| Model numbers | 005280-901, 006889-901 |
Product
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).
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0419-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.