StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with…
Medical device recall Z-0050-2025. Published in FDA’s Enforcement Report on Oct 16, 2024.
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 Oct 16, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 38 states named
- 1,801 systems 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?
Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation radiographic images are taken, information may appear flipped when utilizing the system (180 degree flipped). 2. Pop-up Message - when using CT+Fluouroscopy images with a slice spacing thickness greater than 2mm, the system does not display a pop-up message indicating the slice spacing is not optimal.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
1,801 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Number: 9735762 UDI-DI code: 00763000456986 Serial Numbers: 420002290 N06805776 N07323682 N07323683 N07323687 N07326235 N07334454 N07334475 N07338479 N07338480 N07338482 N07338929 N07354639 N07354642 N07354643 N07354644 N07354645…
Every code shown here, 1,998 characters
Product Number: 9735762 UDI-DI code: 00763000456986 Serial Numbers: 420002290 N06805776 N07323682 N07323683 N07323687 N07326235 N07334454 N07334475 N07338479 N07338480 N07338482 N07338929 N07354639 N07354642 N07354643 N07354644 N07354645 N07355155 N07357492 N07357493 N07360505 N07360506 N07362322 N07362323 N07364218 N07364220 N07364221 N07365158 N07365160 N07365163 N07365164 N07369302 N07369307 N07401810 N07401811 N07401812 N07401813 N07407569 N07418140 N07418141 N07426193 N07427592 N07427593 N07427597 N07428130 N07428133 N07428134 N07428190 N07428192 N07428193 N07428195 N07428197 N07429001 N07436071 N07436073 N07436074 N07438127 N07438128 N07441426 N07441431 N07448170 N07448371 N07448372 N07449575 N07460062 N07460064 N07461619 N07465933 N07469095 N07469096 N07469097 N07469100 N07469789 N07470357 N07470358 N07471822 N07471823 N07475369 N07475370 N07482977 N07505369 N07508757 N07511354 N07511355 N07511359 N07516935 N07525093 N07525094 N07525099 N07529455 N07533927 N07533928 N07533929 N07533930 N07533931 N07533932 N07533933 N07534178 N07534179 N07534180 N07534655 N07534660 N07536564 N07540834 N07540836 N07540840 N07546674 N07546675 N07546676 N07546679 N07546680 N07547570 N07549763 N07549764 N07550571 N07550577 N07552479 N07565206 N07565587 N07579210 N07579211 N07579475 N07581415 N07585678 N07587632 N07587633 N07587635 N07587636 N07587637 N07587859 N07587861 N07587862 N07587863 N07590349 N07590350 N07590351 N07594577 N07594578 N07594581 N07595330 N07595342 N07596952 N07598116 N07605593 N07612697 N07618329 N07620549 N07803571 N07803573 N07803575 N07806782 N07807286 N07807287 N07807288 N07807289 N07807290 N07807291 N07807292 N07807293 N07807294 N07818055 N07818056 N07819346 N07819352 N07819353 N07822371 N07822379 N07826933 N07828615 N07844635 N07845660 N07845663 N07845671 N07858648 N07858649 N07858650 N07858651 N07858652 N07861405 N07864096 N07864097 N07864098 N07874891 N07874892 N07874895 N07874896 N07874899 N07882341 N08074937 N08074938 N08078498 N08081904 N08085721…
FDA’s list runs to 18,134 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 - U.S Nationwide distribution including in the states of AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, TN, TX, UT, VA, WA, WI and WV. The countries of Argentina, AUSTRALIA, AUSTRIA, BAHRAIN, BANGLADESH, BELGIUM, Brazil, BULGARIA, CANADA, CHILE, China, Colombia, Costa Rica, CROATIA, CYPRUS, DENMARK, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE, HUNGARY, ICELAND, India, ISRAEL, ITALY, Japan, Jordan, KAZAKHSTAN, KENYA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, Malaysia, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, OMAN, PAKISTAN, PANAMA, Philippines, POLAND, PUERTO RICO, QATAR, Republic of Korea, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, Singapore, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, Turkey, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM.
The states and territories these words name
38 states and territories.
Every one of them
- Alaska
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- New Hampshire
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Pennsylvania
- Puerto Rico
- South Carolina
- 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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Aug 22, 2024.
- FDA classified it on Oct 10, 2024.
- FDA’s Enforcement Report published it on Oct 16, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Navigation, Inc., of Lafayette, CO.
- 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 18,134 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.