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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Manufacturer
- CooperSurgical, Inc.
- 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
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