AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus,…
Medical device recall Z-2959-2018. Published in FDA’s Enforcement Report on Sep 12, 2018.
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 Sep 12, 2018. 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
- 2889 units 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?
There is the potential for a scenario where a punctured cup of sterilant expires while the system is powered down, upon power-up the unit will not detect the expired cup of sterilant; allowing for subsequent cycles to be run.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems, using VAPROX HC Sterilant, are intended for use in the terminal Sterilization of properly prepared (cleaned, rinsed and dried) metal and nonmetal medical devices in Healthcare Facilities.
2889 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI numbers 00724995151973, 00724995151980, 00724995151997, and 00724995152000, 00724995151997, 00724995154677, 00724995154684, and 00724995154691. Serial numbers: 012320701 012320702 033260705 033250701 033260706 030630806 030730804…
Every code shown here, 1,995 characters
UDI numbers 00724995151973, 00724995151980, 00724995151997, and 00724995152000, 00724995151997, 00724995154677, 00724995154684, and 00724995154691. Serial numbers: 012320701 012320702 033260705 033250701 033260706 030630806 030730804 030770803 030800806 030890801 030910801 030850807 031170801 031540802 031570820 031030803 031690801 031700816 031710847 031500830 031720801 031860805 031540803 031220802 032000818 031650808 031820810 032110802 032240802 032250808 032260801 032290826 032330801 032320808 032270808 032290805 032290825 032330802 032350801 032210820 032380801 032380802 032460801 032460809 032520802 031500819 031850801 032520804 032200804 032460810 032560801 032680807 031770802 032670807 032710803 031500838 032330808 032200805 032560802 032700806 032560804 032750827 032560803 031030802 032750831 032740804 032750832 032820802 032820804 032820803 032820808 032820809 032970828 032820807 032940807 031800802 033010803 033010804 032990805 033080801 033170834 033170833 033110806 033170832 033170835 033290812 032920825 033080802 033120802 033290810 032950811 033170831 033290811 033640813 033080803 033480809 033650803 033650802 033660801 030060912 030060910 030060913 032810803 033530807 033530808 030080911 033120801 033120803 033120804 033240816 033240817 033240818 033240819 030300909 032810805 030130939 030160913 030210902 030220901 030270928 030270929 030280910 030400927 030080909 030080912 030540902 030610909 030480911 030420917 030610902 030440914 030610910 030490906 030490907 030610903 030800809 030700911 030690901 0300800910 030080910 031480807 030900903 031260907 030960922 030830902 030820901 030480910 031060901 030830903 031180902 030770904 030790901 031480941 030720903 030650907 030720901 030720904 031460903 032760810 031620903 031670903 031560904 031700901 031400906 031750914 031820906 031530922 031830904 031750913 030540901 030760923 031830905 032100902 031870904 031970906 031970905 032120901 031380917 031620902 032240909 031100905 031100906 032450914…
FDA’s list runs to 29,028 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) and to countries of: Albania, Algeria, Australia, Austria, Bahrain, Bangladesh, Belgium, Belarus, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Curacao, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, Hungary, Iceland, India, Indonesia, Iran (Islamic Republic of), Iraq, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of Kuwait, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Malta, Mexico, Morocco, Nepal, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Suriname, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, and Vietnam.
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 Jul 26, 2018.
- FDA classified it on Aug 31, 2018.
- FDA’s Enforcement Report published it on Sep 12, 2018.
- FDA terminated it on Mar 30, 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 29,028 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.