Mesa Laboratories Recalls ProSpore Biological Indicators Due to Reduced Resistance
Mesa Laboratories is recalling ProSpore 4 mL Ampoule Biological Indicators because product resistance fell outside label claims within the expiration date.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The issue is a performance deviation (resistance falling outside label claims) rather than a direct contamination or acute injury risk, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Mesa Laboratories Inc is recalling ProSpore 4 mL Ampoule Biological Indicators for steam sterilization, Catalog Number PS-6-50. The recall involves Lot # 637 with an expiration date of 12/2016. The product is intended for use by health care providers to monitor the adequacy of steam sterilization at 121 degrees Celsius.
The recall was initiated because the product resistance has fallen outside of the label claim within the expiration date. This means the biological indicators may not perform as specified on the label, potentially compromising the monitoring of sterilization processes.
The affected product was distributed to healthcare providers in Alabama, Arkansas, California, Florida, Iowa, Missouri, Nebraska, North Carolina, New York, Ohio, and Washington. The product was also distributed internationally, including Mexico and Canada. There was no government or military distribution. Health care providers should stop using the affected product and contact Mesa Laboratories Inc for further instructions.
The recalled product
- Product
- ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. Product Usage: Biological indicator for steam sterilization at 121 deg C intended for use by a health care…
- Manufacturer
- Mesa Laboratories Inc
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)
- Lot # 637
- exp. date 12/2016
Distribution
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