CLASS II Device recall · Reported 4 Jan 2023 · FDA Enforcement Report

Pilling Wecksorb Cylindrical Sponges recalled by Teleflex

Teleflex is recalling Pilling Wecksorb Cylindrical Sponges, distributed in Illinois, Mississippi, Pennsylvania, Tennessee. The recall was initiated on 28 Sep 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 200400, Lot Number: 22B0395
Quantity recalled1,000 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-0772-2023
FDA event ID
91312
Recalling firm
Teleflex, Morrisville, NC
Classification
Class II
Status
Terminated
Recall initiated
28 Sep 2022
FDA classified
28 Dec 2022
Reported
4 Jan 2023
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

28 Sep 2022Recall initiated by company
28 Dec 2022Classified by FDA+91 days
4 Jan 2023Published in enforcement report+7 days

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

Reason for recall

Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Pilling Wecksorb Cylindrical Sponges

Where it was distributed

Domestic distribution to IL, MS, PA, TN.

IllinoisMississippiPennsylvaniaTennessee

Questions about this recall

Is Pilling Wecksorb Cylindrical Sponges recalled?

Yes. Teleflex recalled Pilling Wecksorb Cylindrical Sponges on 28 Sep 2022. The recall is Class II and its status is Terminated. Recall number Z-0772-2023.

Why was it recalled?

Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised.

Which lots are affected?

Catalog Number: 200400, Lot Number: 22B0395

Where was it sold?

Domestic distribution to IL, MS, PA, TN.

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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