The Recall Desk
HighFDA (Devices)·Z-1727-2015·Announced 2015-06-17

CooperSurgical Ally Uterine Positioning System Recalled for Injury Risk

CooperSurgical is recalling five Ally Uterine Positioning System units because the design may expose users to injury to fingers or body parts.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

CooperSurgical, Inc. is recalling five units of the Ally Uterine Positioning System (Ally UPS). This device is used for mounting, positioning, and holding uterine manipulators during gynecological laparoscopic procedures.

The recall was initiated because the design of the device may expose users to injury to fingers or body parts. The affected units have serial numbers 020015, 020021, 020023, 020043, and 020051.

The recalled products were distributed in the states of California, Illinois, North Carolina, and New York. Users should stop using the device and contact the manufacturer for instructions on return or replacement.

The recalled product

Product
Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators during gynecological laproscopic procedures Model: Ally UPS
Hazard
Affected units
5

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Serial Numbers: 020015
  • 020021
  • 020023
  • 020043
  • 020051

Distribution

Distributed in 4 states: