CLASS II Device recall · Reported 3 Apr 2013 · FDA Enforcement Report

Omniflex Diaphragm - Size recalled by Cooper Surgical

Cooper Surgical is recalling Omniflex Diaphragm - Size 65 (Milex Wide Seal Silicone Vaginal Diaphragm), distributed in 15 states. The recall was initiated on 26 Feb 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 113367

Quantity recalled80 individual diaphragms

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1018-2013
FDA event ID: 64510
Recalling firm: Cooper Surgical, Trumbull, CT
Classification: Class II
Status: Terminated
Recall initiated: 26 Feb 2013
FDA classified: 28 Mar 2013
Reported: 3 Apr 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

26 Feb 2013	Recall initiated by company
28 Mar 2013	Classified by FDA	+30 days
3 Apr 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Incorrect size was printed on the outer product packaging.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

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.

Arizona California Florida Massachusetts Maine Missouri Nebraska New Hampshire New Mexico New York Oklahoma Pennsylvania South Carolina Tennessee Texas

Questions about this recall

Why was it recalled?

Incorrect size was printed on the outer product packaging.

Which lots are affected?

Lot 113367

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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