Natus Medical Recalls Olympic Pasteurmatic 3000 and 3500 Disinfection Systems
Natus Medical is recalling Olympic Pasteurmatic 3000 and 3500 systems because they do not fully meet current regulatory requirements due to design age and component obsolescence.
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 explicitly states the reason is non-compliance with regulatory requirements due to design age and obsolescence, with no reported injuries, illnesses, or specific safety hazards like fire or shock mentioned. This aligns with a voluntary precautionary recall or minor compliance issue.
Plain-English summary
Natus Medical Incorporated is recalling the Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 systems. These devices are intended for the cleaning and high-level disinfection of respiratory therapy and anesthesia equipment by killing vegetative bacteria and viruses in a hot water bath. The recall involves a total of 275 units, with 97 units distributed in the United States and 178 units distributed internationally.
The recall was initiated because the devices do not fully meet today's regulatory requirements. The firm cited the age of the product design, component and technology obsolescence, and the time required to fully comply with the latest design and development standards as the reasons for the recall. The firm is recalling the devices by disabling them.
Affected units were distributed nationwide in the United States and in various countries including Canada, Mexico, Japan, and India. Users should check their serial numbers against the list provided by the FDA to determine if their unit is affected. If a unit is affected, it should be disabled as directed by the recalling firm.
The recalled product
- Product
- The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended for cleaning and high-level disinfection of respiratory therapy and anesthesia equipment by killing vegetative bacteria and viruses, in a hot water bath at ~160¿ - ~170¿ F for 30 minutes. Catalog…
- Manufacturer
- Natus Medical Incorporated
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 (20)
- 3041
- 3043
- 3045
- 3050
- 3055
- 3062
- 3071
- 3079
- 3083
- 3084
- 3096
- 3100
- 3113
- 3143
- 3153
- 3155
- 3162
- 3165
- 3174
- 3188
Distribution
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