Z-2521-2026 Class II Ongoing
FDA device recall Z-2521-2026 was initiated by Intuitive Surgical, Inc. on April 22, 2026 and is designated Class II. Reason for recall: 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 … The recall status is ongoing. Affected quantity: 454.
Recall Details
- Product Type
- Devices
- Report Date
- July 1, 2026
- Initiation Date
- April 22, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 454
Product Description
Da Vinci ASSY, PSS, SP1098, Part Number: 380601
Reason for Recall
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.
Distribution Pattern
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.
Code Information
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