CLASS II Device recall · Reported 8 Nov 2017 · FDA Enforcement Report

Alcon Custom Pak recalled by Alcon Research

Alcon Research is recalling Alcon Custom Pak, distributed in Missouri, New York, Wisconsin. The recall was initiated on 8 Aug 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes2033459H, 2034186H, 2034491H

Quantity recalled33 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-0053-2018
FDA event ID: 77965
Recalling firm: Alcon Research, Houston, TX
Classification: Class II
Status: Terminated
Recall initiated: 8 Aug 2017
FDA classified: 27 Oct 2017
Reported: 8 Nov 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

8 Aug 2017	Recall initiated by company
27 Oct 2017	Classified by FDA	+80 days
8 Nov 2017	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

Alcon is initiating a medical device recall, after receiving notification from a supplier of a recall for x-ray detectable sponges. The one product referenced in the supplier recall notification, is used within Alcon Custom Paks.

Product as listed by the FDA

Alcon Custom Pak

Where it was distributed

States in the US - WI, NY, MO

Missouri New York Wisconsin

Questions about this recall

Is Alcon Custom Pak recalled?

Yes. Alcon Research recalled Alcon Custom Pak on 8 Aug 2017. The recall is Class II and its status is Terminated. Recall number Z-0053-2018.

Why was it recalled?

Which lots are affected?

2033459H, 2034186H, 2034491H

Where was it sold?

States in the US - WI, NY, MO

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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