Gyrus Medical, Inc: Medical Device Recall in 2014 - (Recall #: Z-1196-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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).

Product Classification:

Class II

Date Initiated: February 19, 2014

Date Posted: March 19, 2014

Recall Number: Z-1196-2014

Event ID: 67578

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.

Status: Terminated

Product Quantity: 856 units

Code Information:

Lots: MK761655, MK764022, MK767655, MK526401

Distribution Pattern:

US Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated