Z-1018-2013Class II

Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in...

Name: Z-1018-2013 Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in...
Creator: Cooper Surgical, Inc.
Published: 2013-02-26
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2013-02-26 / Terminated / root cause: packaging

FDA source

Cooper Surgical, Inc. began a recall of Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception on 2013-02-26. FDA classified it as Class II and gives the reason as "Incorrect size was printed on the outer product packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1018-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-26
Posted: 2013-03-28
Terminated: 2014-03-04
Recalling firm: CooperSurgical, Inc.
Product: Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm) Model MXWF65 Intended for use in contraception.
Product code: HDW Diaphragm, Contraceptive (And Accessories)
Reason for recall: Incorrect size was printed on the outer product packaging.
Root cause tag: packaging
FDA root cause: Packaging
Action: CSI notified consignees affected by this recall by a Recall Notification letter, dated February 26, 2013, sent via Federal Express with confirmed delivery receipt. The letter identified the affected product, and asked customers to contact the firm's Customer Service Department at 1-800-243-2974, if they had any of the affected lot in their inventory. Customers also have the option of completing the form attached to the letter and faxing it back to 800-262-0105. At CooperSurgical's expense, arrangements will made to replace the affected products that customers have on hand. The firm will provide further instruction and disposition of the product at the time of replacement.
Quantity in commerce: 80 individual diaphragms
Distribution: Worldwide Distribution -- USA, including the states of NE, MA, FL, TN, CA, ME, SC, CA, NH, OK, TX, NM, MO, NY, PA, and AZ, and countries of Germany, Italy, and Canada.
Product codes and lots: Lot 113367

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1018-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1018-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-28

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)