Z-1727-2015Class II

Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine...

Name: Z-1727-2015 Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine...
Creator: CooperSurgical, Inc.
Published: 2015-05-18
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2015-05-18 / Terminated / root cause: design

FDA source

CooperSurgical, Inc. began a recall of Ally Uterine Positioning System (Ally UPS) used in the mounting and positioning and holding of uterine manipulators during gynecological laproscopic procedures... on 2015-05-18. FDA classified it as Class II and gives the reason as "Design of device may expose user to injury to fingers or body parts". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1727-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-18
Posted: 2015-06-08
Terminated: 2015-08-07
Recalling firm: CooperSurgical, Inc.
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
Product code: LKF Cannula, Manipulator/Injector, Uterine
Reason for recall: Design of device may expose user to injury to fingers or body parts
Root cause tag: design
FDA root cause: Device Design
Action: CooperSurgical initiated the recall on May 18, 2015 via Fedex with confirmed delivery receipt. The letter identified the affected product and asked users to discontinue use and complete the Acknowledgement and Receipt Form to schedule a replacement. Questions contact 203.601.5200.
Quantity in commerce: 5 units
Distribution: Distributed in the states of CA, IL, NC, and NY.
Product codes and lots: Serial Numbers: 020015;020021;020023; 020043;020051

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1727-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1727-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-08

Product code LKF

K141523Class IIAlly UpsCooperSurgical, Inc. / cleared 2014-11-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)