Recall archive / FDA device enforcement

StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spin... — FDA record Z-0050-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Aug 22, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: 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.
Reason: 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.
Classification: Class II
Recalling firm: Medtronic Navigation, Inc.
Quantity: 1,801 systems
Agency-reported status: Ongoing
Source record identifier: Z-0050-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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 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Label field

Details supplied by the agency

Lot, code or applicability

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 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N29822158 N29822160 N29822161 N29824309 N29824310 N29824311 N29824500 N29825187 N29825237 N29825261 N29827986 N29830913 N29830919 N29830920 N29830924 N29830925 N29836062 N29836064 N29836065 N29836430 N29836431 N29836433 N29836435 N29836437 N29836438 N29838839 N29838840 N29838841 N29838844 N29838845 N29843734 N29843735 N29843736 N29843737 N29843738 N29843739 N29843740 N29843741 N29843743 N29843744 N29843745 N29845224 N29845225 N29848894 N29849572 N29849573 N29849574 N29849575 N29849652 N29849655 N29849657 N29851124 N29851443 N29851445 N29853878 N29853879 N29853880 N29853881 N29856808 N29856809 N29856812 N29858116 N29858117 N29858122 N29858126 N29858230 N29858231 N29859396 N29859398 N29859400 N29860249 N29861320 N29861321 N29862026 N29862029 N29862030 N29864623 N29867546 N29867547 N29867548 N29867549 N29867586 N29867587 N29867889 N29868014 N29868807 N29868851 N29868852 N29868853 N29868855 N29868857 N29868858 N29869161 N29869162 N29869163 N29871247 N29871248 N29872557 N29872730 N29872737 N29872738 N29873364 N29875639 N29879267 N29881681 N29881682 N29881683 N29882616 N29882804 N29882806 N29882809 N29882815 N29885064 N29885088 N29885089 N29885090 N29885091 N29885092 N29885094 N29885095 N29885096 N29885153 N29885730 N29885732 N29886427 N29886428 N29886429 N29886430 N29886522 N29886523 N29886528 N29890096 N29890097 N29890098 N29890099 N29890100 N29891403 N29891404 N29891405 N29892098 N29896152 N29896153 N29898305 N29898306 N29898307 N29898308 N29898312 N29898372 N29898374 N29898375 N29898376 N29898377 N29898378 N29899351 N29900706 N29900707 N29900708 N29900709 N29900710 N29900711 N29900712 N29900713 N29900970 N29900971 N29900972 N29900973 N29900974 N29900995 N29901101 N29901102 N29901103 N29901971 N29901972 N29901973 N29901974 N29901976 N29901977 N29901978 N29901979 N29903582 N29903715 N29903791 N29903795 N29909843 N29913941 N29913943 N29916480 N29919195 N29921183 N29925864 N29925865 N29925867 N29925868 N29925869 N29925871 N29930372 N29930373 N29930375 N29930376 N29930377 N29930378 N29930379 N29930385 N29930386 N29932139 N29934766 N29934767 N29938110 N29939493 N29943214 N29943215 N29946821 N29946822 N29948628 N29956579 N29956580 N29956581 N29956584 N29956586 N29956587 N29957251 N29957252 N29957253 N29957254 N29960072 N29960078 N29960894 N29960895 N29960896 N29960897 N29960899 N29967249 N29967298 N29967299 N29969352 N29969353 N29975413 N29977065 N29977067 N29977068 N29977070 N29977071 N29980907 N29980908 N29980912 N29980913 N29980914 N29987099 N29987100 N29988801 N29988802 N29988803 N29994603 N29994604 N29994605 N29994607 N29994608 N29994609 N29994610 N29994612 N29998256 N29998258 N30001585 N30001587 N30001588 N30001589 N30001590 N30001591 N30001597 N30003181 N30005600 N30007080 N30007507 N30007508 N30007509 N30007511 N30007522 N30008601 N30008602 N30008604 N30009129 N30009130 N30009134 N30009136 N30018137 N30019272 N30019275 N30019277 N30019278 N30019279 N30019280 N30019281 N30020326 N30020328 N30020330 N30025650 N30026807 N30027807 N30027907 N30027908 N30027909 N30038958 N30038959 N30038960 N30038961 N30038962 N30038963 N30038966 N30043563 N30043564 N30043565 N30043566 N30043567 N30043568 N30046043 N30046048 N30046049 N30046050 N30050854 N30053253 N30053254 N30053255 N30053256 N30054924 N30054925 N30054926 N30055150 N30058285 N30067119 N30067124 N30067131 N30073492 N30073495 N30073498 N30073499 N30384001 N30384007 N30389701 N30389702 N30389703 N30389704 N30389705 N30389706 N30389708 N30389709 N30389710 N30391935 N30391936 N30391937 N30391938 N30396657 N30396658 N30396660 N30396662 N30399399 N30399400 N30402628 N30402629 N30414351 N30414352 N30416387 N30416389 N30416390 N30416392 N30416393 N30416394 N30416395 N30416396 N30416397 N30416398 N30416400 N30420851 N30422271 N30422272 N30422273 N30422275 N30422276 N30422278 N30422279 N30422280 N30422909 N30429440 N30431709 N30431713 N30431719 N30431723 N30431724 N30443160 N30448807 N30448820 N30449284 N30449286 N30449287 N30450675 N30450676 N30450677 N30451163 N30451175 N30451176 N30462308 N30462309 N30462772 N30466851 N30466857 N30466858 N30466861 N30466865 N30466866 N30467500 N30469301 N30469302 N30469304 N30469307 N30469310 N30469313 N30469316 N30469317 N30469320 N30469321 N30469322 N30471330 N30471331 N30471332 N30471333 N30471334 N30471335 N30471336 N30471337 N30471338 N30471339 N30471340 N30471341 N30471342 N30471343 N30471454 N30475008 N30475010 N30480378 N30480380 N30480382 N30480383 N30480384 N30480385 N30480386 N30480387 N30480388 N30480391 N30480392 N30480393 N30480394 N30483897 N30490874 N30490875 N30490877 N30490882 N30490883 N30490884 N30490885 N30490886 N30490887 N30490889 N30492389 N30492391 N30492393 N30492394 N30492396 N30497753 N30497764 N30504364 N30504366 N30504367 N30504377 N30504378 N30508880 N30508881 N30508884 N30508885 N30508890 N30508894 N30510249 N30513601 N30513602 N30513604 N30513606 N30513614 N30513618 N30513620 N30513622 N30513624 N30513625 N30513626 N30513627 N30519272 N30519274 N30519277 N30526707 N30526708 N30530249 N30534707 N30536928-1 N30536930-1 N30537285 N30537286 N30537287 N30537288 N30537289 N30537290 N30537291 N30537297-1 N30537298 N30537299 N30537301 N30537302 N30541201 N30541202 N30541203 N30541204 N30541208 N30544661 N30544671 N30545717 N30545718 N30549518 N30549519 N30549520 N30549521 N30549522 N30549528 N30549536 N30549537 N30549538 N30549540 N30558744 N30569641 N30572111 N30572117 N30573154 N30574297 N30577598 N30577600 N30584145 N30584146 N30584149 N30584150 N30586194 N30586196 S8 N30586197 N30593951 N30593961 N30598453 N30598455 N30598460 N30598463 N30598464 N30598465 N30598469 N30609087 N30609088 N30609089 N30609090 N30609091 N30609092 N30609094 N30610354 N30610355 N30610356 N30610357 N30610822 N30610823 N30613055 N30613056 N30613057 N30613058 N30613629 N30614065 N30614066 N30614067 N30614068 N30614069 N30614071 N30614072 N30614952 N30614955 N30614956 N30614957 N30614958 N30617616 N30617624 N30617629 N30619777 N30619779 N30619780 N30619781 N30619791 N30619792 N30629829 N30629830 N30629831 N30633466 N30633467 N30636361 N30645242 N30645243 N30645248 N30645250 N30650691 N30650692 N30650694 N30650696 N30655264 N30655265 N30655267 N30655268 N30655269 N30655270 N30655275 N30655276 N30655277 N30660153 N30660155 N30660156 N30660157 N30660158 N30660159 N30660160 N30660161 N30660164 N30662349 N30663086 N30663087 N30663088 N30663089 N30663091 N30663092 N30663093 N30663094 N30666234 N30666235 N30666236 N30666238 N30666239 N30666240 N30666241 N30676054 N30681929 N30681937 N30681943 N30681944 N30681945 N30681946 N30681947 N30681949 N30681950 N30682922 N30682951 N30682952 N30682953 N30682954 N30682955 N30682956 N30682957 N30682958 N30685584 N30685585 N30685586 N30685587 N30685588 N30685758 N30685759 N30685760 N30685761 N30685762 N30685763 N30685765 N30685766 N30685771 N30693296 N30693297 N30693298 N30695288 N30695289 N30695401 N30695402 N30695403 N30695404 N30695405 N30695406 N30695407 N30695408 N30695410 N30695411 N30695412 N30695413 N30695414 N30695417-1 N30695419 N30695420 N30701887 N307018...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

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.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Oct 16, 2024
Recall initiation date: Aug 22, 2024
Center classification date: Oct 10, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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