Steris Amsco Warming Cabinet Recalled for Incorrect Temperature Labeling
Steris Corporation is recalling Amsco Warming Cabinets because the quick reference magnet displays incorrect Fahrenheit to Celsius conversions and default temperatures.
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 involves a labeling error (incorrect temperature conversions) rather than a direct physical hazard or reported injury, fitting the criteria for moderate severity.
Plain-English summary
Steris Corporation is recalling 2,319 units of the Amsco Warming Cabinet. The recall was initiated because the firm discovered that information printed on the quick reference magnet is incorrect. Specifically, the Fahrenheit to Celsius temperature conversions and the default Warming Cabinet temperature listed on the magnet are wrong.
The affected units have serial numbers ranging from 0428014026 to 0432115014. These devices were distributed worldwide, including nationwide in the United States and in numerous other countries such as Australia, Canada, China, France, India, and Mexico. The cabinets are used to raise the temperature of blankets, linens, and sterile surgical solutions for various healthcare applications.
Consumers and healthcare facilities should stop using the affected warming cabinets and contact Steris Corporation for instructions on how to proceed. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the temperature of blankets, linens and sterile surgical IV/irrigation solutions to an acceptable level for various surgical, obstetrical, emergency, critical care and other healthcare applications.
- Manufacturer
- Steris Corporation
- Category
- Medical Device — Warming Cabinet
- Hazard
- Affected units
- 2,319
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)
- Serial #'s: 0428014026 - 0432115014
Distribution
Distributed nationwide across the United States.
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