Mesa Laboratories Recalls SporAmpule Biological Indicators Due to Concentration Issue
Mesa Laboratories is recalling SporAmpule Biological Indicators because the concentration of bromocresol purple does not conform to specification.
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 does not report any hospitalizations, injuries, or illnesses. The hazard is a specification non-conformance without reported harm, fitting the criteria for a moderate severity score.
Plain-English summary
Mesa Laboratories Bozeman Manufacturing Facility is recalling 40,000 units of SporAmpule Biological Indicator Catalog Number SPS5-100. The recall involves lots SPS-696, SPS-697, and SPS-698. The product was distributed in the United States, Republic of Korea, Israel, Poland, France, China, Canada, Japan, Singapore, Hong Kong, and Jordan.
The recall was initiated because the concentration of bromocresol purple in the recalled lots does not conform to specification. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Consumers and healthcare facilities should stop using the affected biological indicators and contact Mesa Laboratories for further instructions or a refund.
The recalled product
- Product
- SporAmpule Biological Indicator Catalog Number SPS5-100
- Manufacturer
- Mesa Laboratories Bozeman Manufacturing Facility
- Hazard
- Affected units
- 40,000
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 (3)
- Lots: SPS-696
- SPS-697
- SPS-698
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Mesa Laboratories Bozeman Manufacturing Facility 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.
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