Maquet Compressor Mini Recalled for Excessive Compressed Air Temperature
Maquet is recalling 237 Compressor Mini units because they may deliver compressed air at a temperature higher than specified.
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, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling 237 units of the Compressor Mini. This medical device is intended to provide a supply of dry, filtered compressed air for medical respiratory ventilators or anaesthesia machines in hospital bedside applications.
The recall was initiated because the Compressor Mini may deliver compressed air at a temperature higher than specified. The affected units are identified by part number 6481779.
The product was distributed worldwide, including in the United States, Canada, and Japan. Healthcare providers, physicians, nurses, and technicians who operate these devices should contact Maquet Cardiovascular US Sales, LLC for further instructions on the recall.
The recalled product
- Product
- Compressor Mini To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers, physicians, nurses, and…
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Hazard
- Affected units
- 237
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)
- Part number 6481779
Distribution
Distribution scope not specified by the agency.
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