Intuitive Surgical recalls

Intuitive Surgical has 256 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 22 Jul 2026. 79 are still ongoing. 16 were reported in the last 12 months.

Total recalls256since 2012

Last 12 months16reported

Class I10% of total

Ongoing79latest 22 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 39 0Feb 1 0 0May 0 0 0Aug 0 0 0Nov 1 1 3Feb 0 6 2May 1 2 0Aug 0 0

Severity split

Class I 1 0%Class II 254 99%Class III 1 0%

Why intuitive surgical is recalled

Product types

By year

2026156%
20254116%
202421%
202342%
2022104%
202121%
2020208%
201921%
201883%
2017187%

Ongoing intuitive surgical recalls

79 active

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026Device	CLASS II	da Vinci SP Instrument Arm Drape, SP recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
1 Jul 2026Device	CLASS II	Da Vinci ASSY, PSS, SP1098 recalled by Intuitive Surgical	Intuitive Surgical	Device Malfunction	Nationwide
10 Jun 2026Device	CLASS II	Da Vinci 5 Assy,DV5 Tower,IS5000 recalled by Intuitive Surgical	Intuitive Surgical	Device Malfunction	49 states
13 May 2026Device	CLASS I	Intuitive SureForm 30 Gray Reloads Reference Numbers recalled	Intuitive Surgical	Other	49 states
13 May 2026Device	CLASS II	Da Vinci X and Da Vinci Xi da Vinci X, Xi Surgical System recalled	Intuitive Surgical	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	da Vinci S, Si Tenaculum Forceps Instrument recalled	Intuitive Surgical	Device Malfunction	Nationwide

All intuitive surgical recalls, newest first

256 total

Reported	Class	Recall	Company	Reason	Where
22 Jul 2026Device	CLASS II	da Vinci SP Instrument Arm Drape, SP recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
1 Jul 2026Device	CLASS II	Da Vinci ASSY, PSS, SP1098 recalled by Intuitive Surgical	Intuitive Surgical	Device Malfunction	Nationwide
10 Jun 2026Device	CLASS II	Da Vinci 5 Assy,DV5 Tower,IS5000 recalled by Intuitive Surgical	Intuitive Surgical	Device Malfunction	49 states
13 May 2026Device	CLASS I	Intuitive SureForm 30 Gray Reloads Reference Numbers recalled	Intuitive Surgical	Other	49 states
13 May 2026Device	CLASS II	Da Vinci X and Da Vinci Xi da Vinci X, Xi Surgical System recalled	Intuitive Surgical	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	da Vinci S, Si Tenaculum Forceps Instrument recalled	Intuitive Surgical	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	da Vinci S, Si Double Fenestrated Grasper Instrument recalled	Intuitive Surgical	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	da Vinci S and Si Monopolar Curved Scissors Instrument recalled	Intuitive Surgical	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	da Vinci S, Si Grasping Retractor Instrument recalled	Intuitive Surgical	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	da Vinci S, Si Mega Needle Driver Instrument recalled	Intuitive Surgical	Device Malfunction	Nationwide
8 Apr 2026Device	CLASS II	da Vinci S, Si Permanent Cautery Hook Instrument recalled	Intuitive Surgical	Device Malfunction	Nationwide
25 Feb 2026Device	CLASS II	Da Vinci 5 Assy, DV5 Console, IS5000 recalled by Intuitive Surgical	Intuitive Surgical	Device Malfunction	6 states
18 Feb 2026Device	CLASS II	da Vinci 5 Surgeon Console Viewer Display, Assy, DV5 Console, IS5000 recalled	Intuitive Surgical	Other	Nationwide
11 Feb 2026Device	CLASS II	da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System recalled	Intuitive Surgical	Device Malfunction	30 states
21 Jan 2026Device	CLASS II	da Vinci SP, SP Access Port Kit recalled by Intuitive Surgical	Intuitive Surgical	Sterility	Nationwide
31 Dec 2025Device	CLASS II	da Vinci 5, Surgeon Console Column Motor Connector recalled	Intuitive Surgical	Other	Nationwide
19 Mar 2025Device	CLASS II	Da Vinci 5 Assy,DV5 Console,IS5000 Foot Tray Pedals recalled	Intuitive Surgical	Device Malfunction	Nationwide
22 Jan 2025Device	CLASS II	Fenestrated Bipolar Forceps,is4000 recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025Device	CLASS II	Long Bipolar Grasper,is4000 recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025Device	CLASS II	Mega Suturecut Nd,is4000¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025Device	CLASS II	Tenaculum Forceps,is4000¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025Device	CLASS II	Cadiere Forceps,is4000 ¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025Device	CLASS II	Dual Blade Retractor,is4000¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025Device	CLASS II	Tip-up Fenestrated Grasper,is4000¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025Device	CLASS II	Small Grasping Retractor,is4000¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025Device	CLASS II	Cobra Grasper,is4000 recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025Device	CLASS II	Large Suturecut Needle Driver,is4000¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025Device	CLASS II	Micro Bipolar Forceps,is4000 ¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025Device	CLASS II	Medium-large Clip Applier,is4000¿ recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide
22 Jan 2025Device	CLASS II	Potts Scissors, Is4000 recalled by Intuitive Surgical	Intuitive Surgical	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.