Steris Corporation recalls non-sterile 4-ply sponges sold in the US due to not being approved for 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 the model number ENC4100 and lot number 202108. The recall is because the sponges were not cleared by the FDA for US distribution.
The sponges were not approved by the FDA for distribution in the United States. This means they do not meet US safety and quality standards. Using these products could pose risks related to improper use or failure to meet regulatory requirements.
Anyone who purchased these sponges from US retailers. The recall applies to products sold with model number ENC4100 and lot number 202108.
Check for model number ENC4100 and lot number 202108 on the packaging. These sponges were sold in cases of 2,000 units with 10 sleeves of 200 sponges each.
Do not use the recalled sponges as they were not approved for US distribution.
The sponges were not approved by the FDA for distribution in the United States.
Model number ENC4100 and lot number 202108.
Look for model number ENC4100 and lot number 202108 on the packaging.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-1119-2022 — Steris Steris Hello, I own a Steris that is covered by recall Z-1119-2022 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.
