Summary
The FDA issued a Class II for Da Vinci ASSY, PSS, SP1098, Part Number: 380601 by Intuitive Surgical, Inc.. Reason: Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pi.
Details
Source
Device Recall
External ID
Z-2521-2026
Action Date
2026-07-01
Status
Ongoing
Category
device
Product Description
Da Vinci ASSY, PSS, SP1098, Part Number: 380601
Lot/Code Info: 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
Quantity Affected: 454
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
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-22
Company
Sunnyvale, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 252 device recalls issued in the same week, part of 389 device-related FDA actions this month.
Intuitive Surgical, Inc. has 124 FDA actions in our database, including 74 recalls and 50 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Intuitive Surgical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Intuitive Surgical, Inc. have FDA actions?
Intuitive Surgical, Inc. has 124 FDA actions in our database, including 74 recalls and 50 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2521-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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