Z-1239-2015Class II

CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02

Name: Z-1239-2015 CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
Creator: CooperSurgical, Inc.
Published: 2015-02-09
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2015-02-09 / Terminated / root cause: labeling and UDI

FDA source

CooperSurgical, Inc. began a recall of CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02 on 2015-02-09. FDA classified it as Class II and gives the reason as "Incorrect size printed on the Milex Pessary Kit packaging label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1239-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-09
Posted: 2015-03-03
Terminated: 2016-01-15
Recalling firm: CooperSurgical, Inc.
Product: CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
Product code: HHW Pessary, Vaginal
Reason for recall: Incorrect size printed on the Milex Pessary Kit packaging label
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: CooperSurgical sent an Recall Letter dated February 9, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter asked customers to contact CooperSurgical Product Surveillance Department if they had any questions. At CooperSurgical's expense, arrangements were made to replace any of the affected products that customers had on hand. CooperSurgical provided further instruction on the disposition of the product at the time of replacement. Questions contact CooperSurgical 203.601.5200.
Quantity in commerce: 95 units
Distribution: Nationwide Distribution
Product codes and lots: Lot numbers: 144351, 142789

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1239-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1239-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-11	2015-03-03

Product code HHW

K904026Class IIInflat-O-BallMilex Products, Inc. / cleared 1990-10-10

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)