SteriTec EZTest Steam Biological Indicator Recalled for Labeling Inaccuracy
SteriTec is recalling 200 units of EZTest Steam Biological Indicators because the readout time does not match the 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, but the source text identifies the issue as a labeling/specification discrepancy regarding readout time without reporting any injuries, illnesses, or hospitalizations. This aligns with the rubric for moderate severity involving labeling errors or low-risk issues.
Plain-English summary
SteriTec Products Mfc. Co., Inc. is recalling 200 units of the Mesa EZTest Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ. The affected lot number is S-444. These 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 recall was initiated after Mesa Labs, based in Bozeman, MT, informed SteriTec Products, Inc. that the readout time for the EZTest Steam and Smart-Read Biological Indicators is not in specification with the label claims. This discrepancy means the product may not perform as described on its packaging.
The affected products were distributed worldwide, including nationwide in the United States and in Argentina, Australia, Canada, the British Virgin Islands, the Czech Republic, Italy, and Turkey. Users of these biological indicators should stop using the affected lot and contact the distributor or manufacturer for further instructions.
The recalled product
- Product
- Cardinal Steam Biological Indicator, SteriTec Product Code PL 218, Distributor Product Code T40360EZ 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…
- Manufacturer
- Steritec Products Mfc. Co., Inc.
- Hazard
- Affected units
- 200
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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