Eagle 3000 Sterilizer, small steam sterilizer
Medical device recall Z-0604-2020. Published in FDA’s Enforcement Report on Dec 11, 2019.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 11, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 43 states named
- 236 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (PM) kit for the 3000 Small Sterilizers.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
236, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Serial Numbers: 11729306 R813159712 R832721203 12539208 R812130301 R811500201 R812179701 R813490404 13469106 R813510301 11349304 R812689903 R812430409 13399103 R810790402 100981005 R812629901 106978007 R832880701 R810120405…
Every code shown here, 1,991 characters
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 R810569302 10019309 105185002 R812930301 R813410501 10849312 107080008 132387005 R811690211 R813410502 11239318 106880005 110686003 R813330001 11298909 R811460405 10949203 R812330602 R810870601 13299213 R812290605 10919208 R813190104 R813349502 R812780503 R812559801 R811370104 10299103 R830271201 R810950607 R831730801 10859201 10389102 R811049906 13149002 R812629204 R811370103 13179211 11149202 R811570601 R811050303 R810029702 12819205 11119205 R810670602 R811550403 R830370702 12749205 11129204 109783015 R812490104 10449306 R831561001 11049203 R831370701 13239203 12299303 R831521001 11439120 R831650702 11169410 R811980101 106585015 11309303 R810770203 12679203 R812570107 R812769701 R811240001 R810669607 10449304 R812570108 R812969401 13099205 R810119905 13219410 R811400212 R812819402 12949203 R832190701 R812099802 12959004 R811989501 R811790503 13019214 12729303 13549211 R831860802 R812020501 R813370405 R812989905 R813250109 R812109713 10549307 R811320302 R812350105 11269307 R812169704 10639305 R813280401 R812079001 R813570402 R810390208 R810690306 R831860801…
FDA’s list runs to 2,470 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution - US Nationwide distribution in the states of AL AR AZ CA CO DE FL GA HI IA ID IL IN KS LA MD ME MI MN MO MS MT NC NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV, and country of Canada.
The states and territories these words name
43 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Louisiana
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 22, 2019.
- FDA classified it on Dec 5, 2019.
- FDA’s Enforcement Report published it on Dec 11, 2019.
- FDA terminated it on May 6, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Steris Corporation, of Mentor, OH.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,470 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.