Gyrus Acmi, Incorporated: Medical Device Recall in 2014 - (Recall #: Z-0419-2015)

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: October 21, 2014

Date Posted: December 3, 2014

Recall Number: Z-0419-2015

Event ID: 69584

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.

Status: Terminated

Product Quantity: 74,792 units

Code Information:

All lots

Distribution Pattern:

Worldwide distribution. US Nationwide, Canada, Vietnam, and Europe

Voluntary or Mandated:

Voluntary: Firm initiated