CLASS II Device recall · Reported 11 Mar 2015 · FDA Enforcement Report

Pessary Kit-cube#2 recalled by CooperSurgical

CooperSurgical is recalling CooperSurgical Pessary Kit-cube#2, 1, distributed nationwide in the US. The recall was initiated on 9 Feb 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot numbers: 144351, 142789

Quantity recalled95 units

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-1239-2015
FDA event ID: 70502
Recalling firm: CooperSurgical, Trumbull, CT
Classification: Class II
Status: Terminated
Recall initiated: 9 Feb 2015
FDA classified: 3 Mar 2015
Reported: 11 Mar 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Surgical Instruments

Timeline

9 Feb 2015	Recall initiated by company
3 Mar 2015	Classified by FDA	+22 days
11 Mar 2015	Published in enforcement report	+8 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 printed on the Milex Pessary Kit packaging label

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

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

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Is Pessary Kit-cube#2, 1 recalled?

Yes. CooperSurgical recalled Pessary Kit-cube#2, 1 on 9 Feb 2015. The recall is Class II and its status is Terminated. Recall number Z-1239-2015.

Why was it recalled?

Incorrect size printed on the Milex Pessary Kit packaging label

Which lots are affected?

Lot numbers: 144351, 142789

Where was it sold?

Nationwide Distribution

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 21 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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