The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1273-2018·Announced 2018-04-04

Mesa Laboratories Recalls ProSpore Biological Indicators Due to Concentration Defect

Mesa Laboratories is recalling specific lots of ProSpore 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 describes a specification non-conformance without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.

Plain-English summary

Mesa Laboratories Bozeman Manufacturing Facility is recalling 28,930 units of ProSpore Biological Indicators. The affected part numbers are PS-6-50, PS-5-50, PS-4-10, PS-4-50, and 3471. The specific lots involved are PS-673, PS-674, and PS-675.

The recall was initiated because the concentration of bromocresol purple in these lots does not conform to the required specification. This is a Class II recall, indicating a situation that could temporarily cause or contribute to reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The affected products were distributed in the United States, Republic of Korea, Israel, Poland, France, China, Canada, Japan, Singapore, Hong Kong, and Jordan. Users should stop using the affected lots and contact Mesa Laboratories for further instructions.

The recalled product

Product
ProSpore Biological Indicator Part Numbers: PS-6-50, PS-5-50, PS-4-10, PS-4-50, 3471
Manufacturer
Mesa Laboratories Bozeman Manufacturing Facility
Category
Medical Device — Sterilization Indicators
Hazard
Affected units
28,930

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: PS-673
  • PS-674
  • PS-675

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.

See all 2 products in this recall →

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