Z-1814-2015Class II

MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80

Name: Z-1814-2015 MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
Creator: CooperSurgical, Inc.
Published: 2015-05-20
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2015-05-20 / Terminated / root cause: labeling and UDI

FDA source

CooperSurgical, Inc. began a recall of MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80 on 2015-05-20. FDA classified it as Class II and gives the reason as "A diaphragm size 80 labeled box was incorrectly packaged with a size 85". 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-1814-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-20
Posted: 2015-06-18
Terminated: 2016-01-20
Recalling firm: CooperSurgical, Inc.
Product: MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
Product code: HDW Diaphragm, Contraceptive (And Accessories)
Reason for recall: A diaphragm size 80 labeled box was incorrectly packaged with a size 85.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: CooperSurgical notified consignees by letter on 5/18/15 via Fedex with confirmed delivery receipt.. Accounts requested to discontinue use and complete the attached Acknowledgement and Receipt Form for replacement. CooperSurgical provided further instruction on the disposition of the product at the time of replacement If you have any further questions please feel free to contact 203.601.5200. .
Quantity in commerce: 200 units
Distribution: AK, CA, DC, FL, IL, ME, MT, NE, NJ, NM, NY, OK, OR, P A, VA, W A, and WI Foreign: CANADA, ENGLAND, and POLAND
Product codes and lots: Lot 153309

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1814-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1814-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-24	2015-06-18

Product code HDW

K063223Class IIMilex Contraceptive Diaphragm, Omniflex Diaphragms, Arcing Diaphragms, Wideseal DiaphragmsCooperSurgical, Inc. / cleared 2008-01-23

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)