CLASS II Device recall · Reported 16 Mar 2016 · FDA Enforcement Report

Milex Arcing Diaphragm Size recalled by CooperSurgical

CooperSurgical is recalling Milex Arcing Diaphragm Size 95, distributed in New York, Oregon. The recall was initiated on 16 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot# 130438

Quantity recalled2 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-1054-2016
FDA event ID: 73329
Recalling firm: CooperSurgical, Trumbull, CT
Classification: Class II
Status: Terminated
Recall initiated: 16 Feb 2016
FDA classified: 4 Mar 2016
Reported: 16 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

16 Feb 2016	Recall initiated by company
4 Mar 2016	Classified by FDA	+17 days
16 Mar 2016	Published in enforcement report	+12 days

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

Reason for recall

The products have been identified to contain an incorrect size Diaphragm.

Product as listed by the FDA

Milex Arcing Diaphragm Size 95; Model Number: MXWS95

Where it was distributed

US Distribution to the states of : OR and NY

New York Oregon

Questions about this recall

Is Milex Arcing Diaphragm Size 95 recalled?

Yes. CooperSurgical recalled Milex Arcing Diaphragm Size 95 on 16 Feb 2016. The recall is Class II and its status is Terminated. Recall number Z-1054-2016.

Why was it recalled?

The products have been identified to contain an incorrect size Diaphragm.

Which lots are affected?

Lot# 130438

Where was it sold?

US Distribution to the states of : OR and NY

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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