Steris Eagle 3000 Sterilizer Recall Due to Incorrect Safety Valve
Steris is recalling 236 Eagle 3000 Small Steam Sterilizers because the preventive maintenance kit may contain an incorrect pressure safety valve.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential safety defect (incorrect pressure safety valve) that could lead to injury, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Steris Corporation is recalling 236 units of the Eagle 3000 Small Steam Sterilizer. The recall is due to a potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for these devices.
The affected sterilizers are designed for use in healthcare facilities to sterilize non-porous and porous materials. The units were distributed nationwide in the United States and in Canada.
Healthcare facilities should check their inventory for the specific serial numbers listed in the recall notice. If a unit is affected, the facility should contact Steris Corporation for instructions on how to proceed.
The recalled product
- Product
- Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 Small Sterilizer is designed for sterilization of certain materials used in healthcare facilities, and are available in two configurations: Gravity designed for sterilization of non-porous, heat- and…
- Manufacturer
- Steris Corporation
- Category
- Medical Device — Sterilizer
- Hazard
- Affected units
- 236
Distribution
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