--- title: "Da Vinci ASSY, PSS, SP1098, Part Number: 380601 — FDA record Z-2521-2026 | Is It on Recall" description: "Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would pr" url: https://isitonrecall.com/recall/fda-device-z-2521-2026-da-vinci-assy-pss-sp1098-part-number-380601/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Da Vinci ASSY, PSS, SP1098, Part Number: 380601 — FDA record Z-2521-2026 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 Apr 22, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Da Vinci ASSY, PSS, SP1098, Part Number: 380601 - **Reason**: Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding. - **Classification**: Class II - **Recalling firm**: Intuitive Surgical, Inc. - **Quantity**: 454 - **Agency-reported status**: Ongoing - **Source record identifier**: Z-2521-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2521-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | UDI: 00886874114605. Serial Numbers: 605408, 606848, 612328, 628399, 609353, 614073, 617794, 616769, 10008062, 635659, 631694, 638771, 641430, 694998, 645433, 643209, 954097, 656203, 764644, 656319, 946098, 667190, 666480, 655562, 664662, 680530, 679266, 683974, 674171, 676962, 682694, 686777, 701248, 696877, 688725, 688225, 697922, 700316, 698277, 702699, 709536, 701751, 717804, 705366, 704731, 724178, 703152, 722803, 693262, 736468, 736338, 740359, 742366, 732233, 696089, 724835, 716520, 709987, 728391, 751529, 731765, 672743, 766366, 711517, 735003, 735252, 746457, 746623, 718940, 721722, 691190, 744094, 750174, 738718, 10211920, 759253, 761448, 752536, 812651, 754935, 790597, 811147, 793019, 761000, 812650, 919988, 919987, 913011, 913012, 926423, 759791, 926422, 938794, 771653, 938795, 766365, 963841, 797872, 769736, 794437, 970568, 970562, 977045, 10003059, 957781, 973824, 804588, 10009706, 936269, 10003509, 930240, 936268, 800142, 10003510, 982782, 967667, 10009707, 973355, 944585, 10065786, 935214, 10020729, 10012963, 10020705, 10031145, 10031144, 973825, 10012962, 10036960, 963856, 10711066, 10035476, 795038, 10043635, 944583, 10072852, 10072853, 966079, 10069899, 10076490, 10087446, 10054478, 10080929, 954096, 10130089, 10165287, 942811, 10180162, 10172589, 10103483, 10103484, 10056518, 10092007, 10246370, 10209961, 10183740, 10232634, 504007, 10231116, 10211880, 10194911, 10245457, 10112470, 10189443, 977044, 10238314, 10644376, 10036961, 10274101, 10112471, 10238315, 10172574, 10281524, 10278366, 10252751, 10289629, 10293276, 10261900, 10274102, 10285085, 10281525, 10243796, 10267796, 10278365, 10285084, 10308532, 10318311, 10293274, 10323177, 10322512, 10289630, 10326939, 10293275, 10333333, 10326938, 10492299, 10302474, 10302473, 10368392, 10332310, 10346946, 10354749, 10346943, 10333332, 10346942, 10267795, 10323178, 10295600, 10223509, 10252780, 10396330, 10263730, 10354748, 10337879, 10265272, 10354750, 10384455, 10359960, 10368393, 10366206, 10375031, 10363897, 10396329, 10363898, 10375032, 10375033, 10409934, 10401560, 10409933, 10408268, 10294693, 10408269, 10396331, 10480883, 10499186, 10499185, 10384456, 10502598, 10495654, 10502599, 10505838, 10512168, 10512167, 10512166, 10508290, 10368391, 10556776, 10417803, 10526733, 10417164, 10508289, 10384454, 10492298, 10480878, 10526735, 10526736, 10537191, 10495655, 10526734, 10526732, 530114, 10537202, 10568118, 10308533, 10547839, 10564979, 10550219, 10564978, 10550220, 10550221, 10561240, 10594744, 10575228, 10571615, 10575229, 10583123, 10571614, 10556769, 10583124, 10594746, 10556777, 10564977, 10594743, 10579531, 10613173, 10568117, 10571616, 10615325, 10583126, 10619701, 10594742, 10541679, 10579530, 10561239, 10594745, 10615326, 10590323, 10590322, 10583125, 10615941, 10608089, 10644375, 10604955, 10561241, 10624252, 10647203, 10670710, 10672825, 10624990, 10295599, 10633489, 10622883, 10647201, 10624251, 10686903, 10612973, 10619702, 10672839, 10696000, 10615940, 10659191, 10651445, 10651443, 10682596, 10702363, 10644374, 10653815, 10651444, 10627633, 10686902, 10672840, 10627632, 10695999, 10665125, 10604956, 10480877, 10682597, 10694981, 10633487, 10716881, 10659189, 10728578, 10627631, 10702364, 10734551, 10659190, 10633488, 10734552, 10706206, 650202, 10744259, 10706207, 10766233, 10766236, 10793380, 10759158, 10759159, 10759161, 10763608, 10763609, 10808841, 10766234, 10763611, 10741377, 10759160, 10763610, 10826493, 10776325, 10766235, 10741378, 10744258, 10734553, 10808839, 10808840, 10771126, 10803470, 10793379, 10817400, 10798922, 10803484, 10766232, 10887260, 10830719, 10771125, 10776323, 10815457, 10744257, 10823000, 10776324, 10782092, 10873054, 10879012, 10897582, 10856718, 10889592, 10864698, 10922820, 10912617, 10647204, 10869722, 10889594, 10871773, 10845441, 10859690, 10826495, 10579532, 10782090, 10826494, 10792831, 10883203, 10871774, 10856716, 10856732, 10859689, 10947466, 10798915, 10968849, 10952495, 10957321, 10875232, 10903586, 10927370, 10947464, 10951328, 10981839, 10787962, 10908841, 10908842, 10817401, 10938311, 10933815, 10938312, 10955031, 10927371, 10933816, 10998396, 10927372, 10240354, 10998395, 11004904, 10979952, 10875231, 10912618, 10897581, 10938310, 10991256, 10991257, 10991259, 10895278, 10883202, 10889593, 10912619, 11016764, 11013103 | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide - US Nationwide distribution including in the states of CA, GA, OH, PA, NY, MN, TN, OR, IL, MD, NJ, AL, NV, TX, FL, LA, CT, NC, AZ, IA, MO, WA, MI, WV, WI, KY, KS, VA, OK, MA, IN, CO, SC, SD, MS, NH, UT, ME and the countries of Belgium, Denmark, Sweden, France, Japan, Germany, Israel, Switzerland, South Korea, Czech Republic, Austria, United Kingdom, Italy, Spain, Ireland, Saudi Arabia, Greece, Taiwan, Australia, China, Turkey, Poland, United Arab Emirates, Hong Kong, Romania. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Jul 1, 2026 - **Recall initiation date**: Apr 22, 2026 - **Center classification date**: Jun 22, 2026 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 to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2521-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Intuitive Surgical, Inc. records](https://isitonrecall.com/brand/intuitive-surgical-inc/)