Gyrus ACMI Disposable Falope-Ring Band Applicator Kits — Class II medical device recall Z-1196-2014
Terminated recall by Gyrus Medical, Inc, reported 2014-03-19. Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, it is possibl
| Recall number | Z-1196-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gyrus Medical, Inc, Osseo, MN, United States |
| Recall initiated | 2014-02-19 |
| Classified | 2014-03-13 |
| Reported by FDA | 2014-03-19 |
| Terminated | 2015-04-14 |
| Quantity | 856 units |
| Reason classes | sterility, packaging |
| Lot numbers | MK526401, MK761655, MK764022, MK767655 |
| 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
Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. The breach may or may not be easily seen.
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-1196-2014. 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.