CLASS II Device recall · Reported 1 Jun 2022 · FDA Enforcement Report

Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2 10 sleeves recalled

Steris is recalling Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2 10 sleeves of 200 / x, distributed nationwide in the US. The recall was initiated on 22 Mar 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 202108

Quantity recalled152 cases

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-1119-2022
FDA event ID: 90050
Recalling firm: Steris, Mentor, OH
Classification: Class II
Status: Terminated
Recall initiated: 22 Mar 2022
FDA classified: 20 May 2022
Reported: 1 Jun 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Hidden Drug Ingredients
Device type: Other Medical Devices

Timeline

22 Mar 2022	Recall initiated by company
20 May 2022	Classified by FDA	+59 days
1 Jun 2022	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

Product not approved for release for US distribution

Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.

Product as listed by the FDA

Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4 in / 10.2 cm x 10.2 cm Model Number: ENC4100

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Product not approved for release for US distribution

Which lots are affected?

Lot Number: 202108

Where was it sold?

Nationwide

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.

Other products in this recall event

1 other product · FDA event 90050

This product is part of a recall event; the main page for the event is Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5 25 sleeves recalled.

Reported	Class	Recall	Company	Reason	Where
1 Jun 2022	CLASS II	Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5 25 sleeves recalled	Steris	Hidden Drug Ingredients	Nationwide

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