Eagle 3000 Sterilizer — Class II medical device recall Z-0604-2020
Terminated recall by Steris Corporation, reported 2019-12-11, distributed nationwide. Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for th
| Recall number | Z-0604-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2019-10-22 |
| Classified | 2019-12-05 |
| Reported by FDA | 2019-12-11 |
| Terminated | 2020-05-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 236 |
| Serial numbers | 10019309, 10019310, 10079311, 100981005, 101085003, 101680009, 10219310, 10219406, 10299103, 10309307, 10319205, 10359401, 10369307, 10389102, 104286006, 10429201, 10449304, 10449306, 10459406, 10459408, 105185002, 10549307, 10569310, 10599202, 10639305 and 211 more |
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 for recall
Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0604-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.