The Recall Desk
HighFDA (Devices)·Z-0604-2020·Announced 2019-12-11

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.

What this means for you

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 m
Manufacturer
Steris Corporation
Category
Medical Device — Sterilizer
Hazard
Affected units
236

Distribution

Distributed nationwide across the United States.

The notice also names 43 states specifically:

Related recalls

Same manufacturer · Steris Corporation

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