InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product…
Medical device recall Z-2700-2020. Published in FDA’s Enforcement Report on Aug 5, 2020.
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 Aug 5, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1283 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?
A recent FDA inspection at the firm identified that the foil test performed during installation of the device does not have clear acceptance criteria.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides sonic irrigation (ultrasonic cavitation) to both interior and exterior of lumened instruments.
1283, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial numbers 11167539801 11167539802 11167539803 01167539804 12167539806 11167440102 01177735903 11167539811 01177735902 01177735901 01177735906 01177735904 01177735905 12167539808 01167539810 02177975001 12167539809 01177736803…
Every code shown here, 1,997 characters
Serial numbers 11167539801 11167539802 11167539803 01167539804 12167539806 11167440102 01177735903 11167539811 01177735902 01177735901 01177735906 01177735904 01177735905 12167539808 01167539810 02177975001 12167539809 01177736803 01177736804 01177736805 01177736806 01177736808 02177975002 01177736807 02177956701 02177956702 02177956703 02177956704 02177956705 03177956706 02177956710 03177956707 03177956708 02177956711 03177956709 03177956901 03177956902 02177956907 03177956903 03177956904 03177956905 03177956906 03177957111 04177957105 04177957106 04177957107 04177957108 04177957109 04177957110 05178203702 05178203703 05178203704 05178203705 05178203701 05178203706 05178203707 05178203708 05178203709 05178203710 06178204001 06178204002 06178204003 06178204004 06178204006 06178204007 06178204009 01177736802 06178204010 04177957112 04178203711 06178460901 06178460902 06178460903 06178460904 06178460905 06178460906 06178460907 0817 87702 01 0817 87702 02 06178460908 06178460909 06178460910 06178460911 06178460912 06178460913 06178460914 06178460915 05178203713 08178478301 06178204011 08178478302 08178478303 06178204012 08178478304 08178478305 08178478306 08178478307 08178478308 06178460917 08178478309 08178478310 08178478311 08178478312 08178478314 08178478315 0917 88031 01 0917 88031 02 0917 88031 03 0917 88031 04 0917 88031 05 0817 87702 04 0817 87702 03 07178460918 09178427701 09178427702 09178427703 09178427704 09178427705 06178204005 09178803106 09178803107 09178803108 09178803109 09178803110 09178427706 09178427707 09178427708 09178427709 09178427710 09178803111 1017 88034 01 08178478317 1017 88034 02 0917 87702 06 09178478318 1017 88034 03 1017 88034 05 1017 88034 06 1017 88034 07 10178427712 0917 87702 07 1017 88034 08 1017 88034 09 1017 88034 10 1017 88034 11 1017 88034 12 1017 88034 13 1017 88034 14 08178478313 1017 88034 15 1217 88033 01 1217 88033 02 1217 88033 03 1217 88033 04 1217 88033 05 1217 88033 06 01188948301 01188948302 10178427713 01188948303…
FDA’s list runs to 15,521 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 and the countries of Canada, Mexico, and United Arab Emirates.
These words name no state.
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 Jun 26, 2020.
- FDA classified it on Jul 24, 2020.
- FDA’s Enforcement Report published it on Aug 5, 2020.
- FDA terminated it on Dec 22, 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 15,521 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
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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.