Cooper Surgical, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0440-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Cooper Surgical Advincula Arch , Reusable Uterine Manipulator Handle Ref: UMH750 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a uterus is present and where positioning of the uterus, fallopian tubes and ovaries is desirable. These types of surgeries include laparoscopic tubal ligation, and/or operative laparoscopy

Product Classification:

Class II

Date Initiated: October 31, 2012

Date Posted: December 5, 2012

Recall Number: Z-0440-2013

Event ID: 63681

Reason for Recall:

Excessive pressure exerted on the uterine tip when attached to the Arch may, under certain circumstances, cause the internal steel rod of the tip to protrude through the cleaning hole on the shaft of the handle

Status: Terminated

Product Quantity: 1215 total

Code Information:

Arch handles with a serial number less than 1204001, or between 1111001 0 and 1111 0069

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Czech Republic, Germany, Italy, Spain, France, United Kingdom, Japan, New Zealand, South Korea, Saudi Arabia, Sweden, Singapore, Slovenia, and Taiwan.

Voluntary or Mandated:

Voluntary: Firm initiated