Steris Recalls Ultra Pure Non-Woven Sponges for Unapproved Distribution
Steris Corporation is recalling 103 cases of Ultra Pure Non-Woven Sponges (Lot 202108) distributed nationwide because the product was released without FDA approval. Customers should discontinue use and contact the manufacturer.
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, injuries, or deaths. The hazard is regulatory non-compliance (lack of FDA approval) rather than a demonstrated product defect.
Plain-English summary
Steris Corporation is recalling Ultra Pure Non-Woven Sponges, 4-ply, non-sterile, 2 inches by 2 inches in size. The recall affects 103 cases (lot number 202108) that were distributed nationwide. The product was released for distribution in the United States without obtaining the required FDA approval.
Medical devices are required to receive FDA clearance or approval before being distributed in the US market. This product does not have such authorization and should not be used or distributed.
Customers who have purchased or received this product should stop using it immediately and contact Steris Corporation for instructions on return or disposal. Healthcare facilities and other end-users should verify they do not have stock of this recalled lot.
The recalled product
- Product
- Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2 in / 5.1 cm x 5.1 cm Model Number: ENC100
- Manufacturer
- Steris Corporation
- Category
- Medical Device
- Hazard
- Affected units
- 103
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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