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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Hazard
- Affected units
- 152
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.
Part of a larger recall action
This product is one of 2 recalled by Steris Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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