Z-0439-2013Class II

Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch...

Name: Z-0439-2013 Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch...
Creator: Cooper Surgical, Inc.
Published: 2012-10-31
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2012-10-31 / Terminated / root cause: design

FDA source

Cooper Surgical, Inc. began a recall of Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 The intended use of the RUMI Arch is in an operative endoscopy (laparoscopy) where a... on 2012-10-31. FDA classified it as Class II and gives the reason as "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". 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-0439-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-31
Posted: 2012-11-26
Terminated: 2014-03-04
Recalling firm: CooperSurgical, Inc.
Product: Cooper Surgical RUMI Arch, Reusable Uterine Manipulator Handle Ref: UMH700 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 code: LKF Cannula, Manipulator/Injector, Uterine
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
Root cause tag: design
FDA root cause: Device Design
Action: CooperSurgical issued notification on October 31, 2012, to all affected customers Fed X . The notification identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return units for replacement. Customers with questions should contact Customer Serivce at 1-203-601-9818 or 800-243-2974. Customers were asked to fill out the attached Replacement of Recalled Product Form and fax it to 1-800-262-0105. For questions regarding this recall call 203-601-9818.
Quantity in commerce: 1215 total
Distribution: 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.
Product codes and lots: All serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0439-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0439-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-05	2012-11-26
Z-0440-2013	Class II	Terminated	Voluntary: Firm initiated	2012-12-05	2012-11-26

Product code LKF

K932115Class IIRowden Uterine Manipulator Injector and RumiBlairden Precision Instruments, Inc. / cleared 1994-06-24

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)