SteriTec Steam Biological Indicators Recalled for Labeling Inaccuracy
SteriTec is recalling 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. The hazard is a labeling/specification discrepancy regarding readout time, which is a minor labeling error or low-risk contamination issue without reported injuries or illnesses.
Plain-English summary
SteriTec Products Mfc. Co., Inc. is recalling 8,200 units of Medline Steam Biological Indicators, specifically the SteriTec Product Code PL 353 and Distributor Product Code MDS200525. The affected product is the Mesa EZTest Steam Biological Indicator, which is intended for monitoring the efficacy of steam sterilization cycles at 121°C, 132°C, 134°C, and 135°C.
The recall was initiated because Mesa Labs, based in Bozeman, MT, informed SteriTec that the product's readout time is not in specification with the label claims. This discrepancy affects the accuracy of the biological indicator's performance monitoring.
The affected lot number is S-444. The 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 should stop using the affected biological indicators and contact the recalling firm for further instructions.
The recalled product
- Product
- Medline Steam Biological Indicators, SteriTec Product Code PL 353, Distributor Product Code MDS200525 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
- 8,200
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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