The Recall Desk
ModerateFDA (Devices)·Z-1119-2022·Announced 2022-06-01

Steris Non-Woven Sponges recalled; product not approved for US distribution

Steris Corporation is recalling 152 cases of Ultra Pure Non-Woven Sponges because the product was not approved for release for US distribution.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The recall is driven by regulatory non-approval for US distribution rather than a specific safety defect, fitting the criteria for voluntary precautionary recalls.

Plain-English summary

Steris Corporation is recalling 152 cases of Ultra Pure Non-Woven Sponges that are non-sterile and 4-ply, with dimensions of 4 inches by 4 inches (Model ENC4100). Each case contains 2,000 sponges packaged in 10 sleeves of 200 sponges each. The recall was initiated because the product was not approved for release for US distribution.

The recalled sponges were distributed nationwide. The affected product is identified by Lot Number 202108.

The recalled product

Product
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
Manufacturer
Steris Corporation
Category
Medical Device — Surgical Supplies
Hazard
  • regulatory-non-approval

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: 202108

Distribution

Distributed nationwide across the United States.

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