FDA Device recall Z-0604-2020
Eagle 3000 Sterilizer, small steam sterilizer
- FDA Device
- Class II
- terminated
- Published 2019-12-11
On 2019-12-11 the FDA classified a Class II recall of Eagle 3000 Sterilizer, small steam sterilizer by Steris, citing potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0604-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-22 |
| Published | 2019-12-11 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Steris |
| Distribution | US |
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 moisture stabile goods, and sterilization of items intended for immediate use. Prevacuum designed for fast, efficient sterilization of porous, heat- and moisture-stabile materials, in addition to the same sterilization capabilities as a Gravity sterilizer.
Reason
Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers.
Identifiers
| code_info | Product Serial Numbers: 11729306 R813159712 R832721203 12539208 R812130301 R811500201 R812179701 R813490404 13…Product Serial Numbers: 11729306 R813159712 R832721203 12539208 R812130301 R811500201 R812179701 R813490404 13469106 R813510301 11349304 R812689903 R812430409 13399103 R810790402 100981005 R812629901 106978007 R832880701 R810120405 R812789806 R811830206 R813500402 R810629201 R811050302 R812439601 R832291101 13369306 104286006 R813020412 R812360406 R831140901 101085003 R831380701 R813210405 R810410302 R833420901 R812820601 R810350503 R810140502 R812050102 R831391002 R833220902 12448403 R810290504 R813450203 11029301 R810819305 R813539903 10319205 R810580403 R1683042006 R812379902 107887005 R811730502 R811829803 10079311 R810590201 R810210203 R811540503 R812599701 R811490303 R810570201 10219406 R812430502 R812280003 R811310001 10219310 10459406 R812530502 12929207 R810089901 R832791102 10359401 R811110501 R831740901 R811760202 128887017 10459408 R810550502 10369307 10599202 130187010 10309307 R810740501 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0604-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.