Intuitive Surgical, Inc.: 134 recalls on record

Recalls filed with 1 agency: FDA (134).

First recall on record: August 8, 2012. Most recent: July 22, 2026.

Risk classification: Class I: 1 · Class II: 132 · Class III: 1

Most recent recalls

DateAgencyProduct
July 22, 2026FDAda Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15Z-2722-2026
July 1, 2026FDADa Vinci ASSY, PSS, SP1098, Part Number: 380601Z-2521-2026
June 10, 2026FDABrand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746…Z-2310-2026
May 13, 2026FDABrand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Mo…Z-2046-2026
May 13, 2026FDAIntuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06Z-1855-2026
April 8, 2026FDABrand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, S…Z-1701-2026
April 8, 2026FDABrand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Me…Z-1698-2026
January 21, 2026FDAda Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1…Z-1096-2026
December 31, 2025FDAda Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part Num…Z-0964-2026
January 22, 2025FDA8MM,MEGA SUTURECUT ND,IS4000 REF 471309Z-0880-2025
January 22, 2025FDA8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 ¿ REF 470033Z-0851-2025
January 22, 2025FDA8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401Z-0870-2025
January 22, 2025FDA8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205Z-0859-2025
January 22, 2025FDA8MM,LONG TIP FORCEPS,IS4000 REF 471048Z-0872-2025
January 22, 2025FDA8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006Z-0849-2025
January 22, 2025FDA8MM,RESANO FORCEPS,IS4000 ¿ REF 470181Z-0857-2025
January 22, 2025FDA8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000¿ REF 470246Z-0862-2025
September 4, 2024FDAIon Endoluminal System, REF: 380748-65Z-2720-2024
April 17, 2024FDAPatient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098Z-1518-2024
March 22, 2023FDAPatient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surg…Z-1262-2023
November 2, 2022FDAda Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon C…Z-0133-2023
June 8, 2022FDAVESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vin…Z-1209-2022
May 4, 2022FDAda Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Cu…Z-0999-2022
December 2, 2020FDABox Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to n…Z-0489-2021
June 17, 2020FDASTAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product U…Z-2328-2020

Questions about this company

How many recalls does Intuitive Surgical, Inc. have?
Recalert has 134 U.S. recalls on record for Intuitive Surgical, Inc., published between August 8, 2012 and July 22, 2026.
What was the most recent Intuitive Surgical, Inc. recall?
FDA recall Z-2722-2026, published July 22, 2026: da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Which agencies have handled Intuitive Surgical, Inc. recalls?
Intuitive Surgical, Inc. appears as the recalling firm in recalls from: FDA (134).

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