The Recall Desk
ModerateFDA (Devices)·Z-1118-2022·Announced 2022-06-01

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.

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, 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
  • unapproved-device

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.

Related recalls

Same category