Da Vinci ASSY, PSS, SP1098, Part Number: 380601
FDA Device Recall #Z-2521-2026 - Class II, April 22, 2026
Recall Summary
| Recall Number | Z-2521-2026 |
| Classification | Class II - Moderate risk |
| Date Initiated | April 22, 2026 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Intuitive Surgical, Inc. |
| Location | Sunnyvale, CA |
| Product Type | Devices |
| 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.
Lot / 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
Other Recalls from Intuitive Surgical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2310-2026 | Class II | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 ... | Apr 24, 2026 |
| Z-2046-2026 | Class II | Brand Name: Da Vinci X and Da Vinci Xi Product... | Apr 2, 2026 |
| Z-1855-2026 | Class I | Intuitive 8 mm SureForm 30 Gray Reloads Refer... | Mar 11, 2026 |
| Z-1355-2026 | Class II | da Vinci 5 Surgeon Console Viewer Display, ASSY... | Dec 30, 2025 |
| Z-1096-2026 | Class II | da Vinci SP, SP Access Port Kit, Large Incisio... | Dec 15, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.