SteriTec EZTest Steam Biological Indicator Recall for Label Inaccuracy
SteriTec is recalling EZTest Steam Biological Indicators because the readout time does not match label claims.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class II, and the hazard is a labeling/specification discrepancy regarding readout time rather than a direct physical or biological hazard causing immediate injury.
Plain-English summary
Steritec Products Mfc. Co., Inc. is recalling 14,900 units of EZTest Steam Biological Indicators, specifically Product Codes EZS and EZS-400, Lot No. S-444. The recall was initiated after Mesa Labs, based in Bozeman, MT, informed SteriTec that the product's readout time is not in specification with the label claims.
The affected biological indicators are self-contained devices intended for monitoring the efficacy of steam sterilization cycles at temperatures of 121°C, 132°C, 134°C, and 135°C. The product has a recommended incubation time of 24 hours. The recall covers units distributed worldwide, including the United States (nationwide) and Argentina, Australia, Canada, the British Virgin Islands, the Czech Republic, Italy, and Turkey.
No specific instructions for consumers or healthcare facilities are provided in the source text regarding how to handle the recalled units.
The recalled product
- Product
- EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam Biological Indicator: Mesa EZTest Steam Biological Indicator is a self contained Biological Indicator intended for monitoring the efficacy of 121¿C, 132¿C, 134¿C and 135¿C steam…
- Manufacturer
- Steritec Products Mfc. Co., Inc.
- Hazard
- Affected units
- 14,900
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 (1)
- Affected Biological Indicator Lot No.: S-444
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Steritec Products Mfc. Co., Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
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