Steris recalls specific sterilization indicator packs from June to August 2021 due to potential temperature excursions affecting product effectiveness. Affected items include Celerity and Verify models with model numbers LCB053, PCC006, S3069, LCB044, LCB049, and LCB035.
Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
Steris is recalling certain sterilization indicator packs that were shipped between June 1, 2021, and September 30, 2021. These products may have been exposed to temperatures that could reduce their effectiveness, which is critical for medical sterilization processes.
The sterilization indicators may have been exposed to higher temperatures during shipping or storage between June 2021 and August 2021. This could reduce their ability to accurately show when sterilization is complete, potentially leading to unsafe medical procedures if the indicators fail.
Healthcare facilities that received these sterilization indicator packs between June 1, 2021, and September 30, 2021. Staff using these products for medical sterilization are most at risk if the indicators fail to properly signal sterilization effectiveness.
Check for model numbers LCB053, PCC006, S3069, LCB044, LCB049, or LCB035 on the packaging. These products were shipped between June 1, 2021, and September 30, 2021, and may have been affected by temperature excursions.
Identify the model number on the packaging to confirm if it is one of the recalled items (LCB053, PCC006, S3069, LCB044, LCB049, or LCB035).
Ensure the product was shipped between June 1, 2021, and September 30, 2021, as these are the affected timeframes.
Steris is recalling these sterilization indicator packs because they may have been exposed to higher temperatures during shipping or storage between June 2021 and August 2021, which could reduce their effectiveness.
The affected model numbers are LCB053, PCC006, S3069, LCB044, LCB049, and LCB035.
The recall does not specify a remedy, so no action is required beyond checking if your product is affected and verifying the shipping dates.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-1793-2022 — Steris Steris Hello, I own a Steris that is covered by recall Z-1793-2022 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.
