V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
Medical device recall Z-0772-2018. Published in FDA’s Enforcement Report on Mar 7, 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 Mar 7, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 45 states named in where it went
- 406 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?
Correction to update sterilizer software to prohibit the use of expired sterilant prior to the start of a sterilization cycle.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
406, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial numbers: 031591505 031611402 032941412 031831609 030261761 033161412 030991616 032641604 031451507 031621401 031691412 032941414 032861406 032941415 033141452 032861409 033161411 030231501 033241412 033241413 033241414 030231504…
Every code shown here, 1,996 characters
Serial numbers: 031591505 031611402 032941412 031831609 030261761 033161412 030991616 032641604 031451507 031621401 031691412 032941414 032861406 032941415 033141452 032861409 033161411 030231501 033241412 033241413 033241414 030231504 030231505 030231507 030231509 030231502 033151407 030341528 030441516 030231506 030231508 030341524 030341535 030361549 030361550 030501523 030501524 030501525 030681530 030681532 030341527 030681531 030341532 030341530 030441517 030341533 030441518 032861410 030341529 030501526 032941413 031191508 033181425 030341526 030441519 030441520 030501528 031191511 031271517 031191509 031191510 031341503 031341504 031271520 031271524 031351514 031451508 031351510 031351515 031411503 030341534 031411501 031411502 031451511 031451512 031271518 031591501 031591502 031591509 031591510 031591512 030361552 031451506 031541506 031451503 031541501 031541502 031541505 031541507 031541504 031591503 031591504 030681534 031351513 031591513 031631513 031631512 031631510 032111549 032181502 031631514 031771513 031831519 031771510 031771511 030361551 031701509 032281501 032361504 031771508 031771509 032361501 032401540 032401543 032221503 032221504 032281502 032361502 032361503 031271519 032281503 032281504 031831523 032181504 032401551 031951550 031951552 032401544 032471517 031951553 032681519 032611502 033161412 031271522 032541587 032181501 032611504 032611505 032681520 032681521 031631506 031831518 031831520 031771512 031701503 031591511 031631508 031841503 031841504 031631511 032611503 031951551 031901514 031701507 031901502 031901512 031771506 031631507 031701502 031831522 031841501 032751511 031701504 031701508 031771504 031901510 031951549 031841502 031841505 031901508 032061502 032061505 032061503 032061506 031701501 032111551 032111552 030121604 033521518 030121602 033451528 031451504 032681518 030221608 031541503 031771505 031771507 033521520 033521519 033521521 030221602 030351647 033521522 030141621 030141622 032061504 030221605 030291624…
FDA’s list runs to 4,075 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.
Distributed in 44 states: AL, AK, AZ, AR, CA, CO, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY; Puerto Rico, and the following countries: Algeria, Australia, Azerbaijan, Bahrain, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, Colombia, Costa Rica, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Republic of Korea, Kuwait, Latvia, Malaysia, Mexico, Morocco, Myanmar, Panama, Peru, Philippines, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates, and Vietnam.
The states and territories these words name
45 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Delaware
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Sep 28, 2017.
- FDA classified it on Feb 27, 2018.
- FDA’s Enforcement Report published it on Mar 7, 2018.
- FDA terminated it on Sep 12, 2018.
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: E-Mail.
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 4,075 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.