Steris Endo Cleaning Indicator Recalled Due to Temperature Excursion
Mckesson Medical-Surgical is recalling Steris Endo Cleaning Indicator VERIFY RESITEST devices due to temperature excursions that occurred on January 8, 2024. The temperature drop could cause the indicator to produce incorrect or delayed test results.
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 or injuries. The hazard is theoretical—temperature excursions could increase the probability of incorrect or delayed test results, but this is a precautionary recall of already-affected units with no direct injury reports.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling the Steris Endo Cleaning Indicator VERIFY RESITEST device due to a temperature excursion that occurred on January 8, 2024. A mechanical failure in a walk-in refrigerator caused storage temperatures to fall below the validated range of 35.6-46.4°F (2-8°C) for up to 60 minutes. This temperature excursion could increase the probability that the indicator will produce an incorrect test result or delayed test result.
The recall affects 25 units that were distributed nationwide in Arizona, Pennsylvania, and Texas. Affected devices are identified by Catalogue Number LCC101 and UDI/DI 10724995220072.
The recalled product
- Product
- Steris Corporation Endo Cleaning Indicator VERIFY" RESITEST"
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- incorrect-test-result
- delayed-test-result
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 (2)
- Catalogue Number: LCC101
- UDI/DI: 10724995220072
Distribution
Distributed nationwide across the United States.
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