Steris Corporation recalls non-sterile 4-ply sponges not approved for US distribution. Consumers should not use these products as they were not cleared for sale in the United States.
Product not approved for release for US distribution
Steris Corporation is recalling non-sterile 4-ply sponges that were not approved for sale in the United States. These products were distributed under a model number (ENC100) and lot number (202108) but were not cleared by the FDA for US distribution.
These sponges were not approved by the FDA for distribution in the United States. Using products not cleared by the FDA could lead to health risks if they are used in medical or food preparation contexts where safety standards are critical.
Anyone who purchased these sponges from US retailers. The risk is highest for users who might have used them in medical or food preparation settings without verifying FDA approval.
Check for model number ENC100 and lot number 202108 on the packaging. These sponges were sold in cases of 5,000 pieces with 25 sleeves of 200 sponges each.
Look for model number ENC100 and lot number 202108 on the packaging to confirm if your sponges are recalled.
No, these sponges were not approved for US distribution by the FDA and should not be used.
Check for model number ENC100 and lot number 202108 on the packaging. These sponges were sold in cases of 5,000 pieces with 25 sleeves of 200 sponges each.
The recall does not specify a remedy, so contact Steris Corporation directly for guidance.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-1118-2022 — Steris Steris Hello, I own a Steris that is covered by recall Z-1118-2022 from Steris. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
