Steris Corporation recalls Endo Cleaning Indicator VERIFY" RESITEST" due to temperature excursions in refrigerators causing potential incorrect or delayed test results. Affected units sold in the U.S. from January 2024.
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.
Steris Corporation is recalling Endo Cleaning Indicator VERIFY" RESITEST" devices because refrigerators they were stored in experienced temperature drops below safe levels, which could lead to incorrect or delayed test results. This affects medical facilities using these indicators for critical testing.
The indicators were stored in walk-in refrigerators that experienced mechanical failures on January 8, 2024. This caused temperatures to drop below the safe range of 35.6-46.4°F (2-8°C) for up to 60 minutes, potentially leading to incorrect or delayed test results.
Medical facilities that use Steris Endo Cleaning Indicator devices for critical testing are most at risk. The recall applies to units sold in the U.S. starting January 2024.
Check for the Steris Endo Cleaning Indicator VERIFY" RESITEST" with Catalogue Number LCC101. The UDI/DI number 10724995220072 is also associated with this product.
Verify the product's Catalogue Number (LCC101) and UDI/DI number (10724995220072) to confirm if it is affected.
The recall is due to temperature excursions in walk-in refrigerators that caused the indicators to be stored at unsafe temperatures, potentially leading to incorrect or delayed test results.
The safe temperature range is 35.6-46.4°F (2-8°C). The indicators were stored below this range for up to 60 minutes.
Look for the Steris Endo Cleaning Indicator VERIFY" RESITEST" with Catalogue Number LCC101 and UDI/DI number 10724995220072.
We’ve drafted a message you can send Steris to request your refund or repair — edit it as you like.
Subject: Recall Z-1313-2024 — Steris Steris Hello, I own a Steris that is covered by recall Z-1313-2024 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.
