SteriTec Steam Biological Test Packs Recalled for Labeling Inaccuracy
SteriTec is recalling specific steam biological test packs 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 specific defect is a labeling inaccuracy regarding readout time rather than a direct safety hazard like contamination or structural failure, fitting the Moderate criteria for minor labeling errors.
Plain-English summary
Steritec Products Mfc. Co., Inc. is recalling Medline Med-Checks BI Test packs with Instant Readout Integrator, specifically SteriTec Product Code PL 200 and Distributor Product Code MDS200500IR. The recall involves 3,535 units of Biological Indicator Lot No. 130401.
The recall was initiated because 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. These products are steam sterilization monitors designed for biological testing of pre-vacuum steam sterilizers.
The affected units were distributed worldwide, including the United States (nationwide), Argentina, Australia, Canada, the British Virgin Islands, the Czech Republic, Italy, and Turkey. Users should stop using the affected test packs and contact the manufacturer or distributor for further instructions.
The recalled product
- Product
- Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a…
- Manufacturer
- Steritec Products Mfc. Co., Inc.
- Hazard
- Affected units
- 3,535
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.:130401
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
Same manufacturer · Steritec Products Mfc. Co., Inc.
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