Skip to content
RecallWatchMedical Device Safety
Class IIOngoingZ-2310-2026

Intuitive Surgical, Inc. recalls Brand Name: Da Vinci 5 Product Name: ASSY

Intuitive Surgical, Inc.Sunnyvale, CA, United StatesReported Jun 10, 2026 · 1 month ago
Legal News Analyst ·

Reason for recall

Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A Product Description: Preface: This report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system. Product Description: The NIR handheld camera system is compatible for use with the da Vinci¿ 5 system to aid in surgery. The components of the NIR handheld camera system include a camera control unit and a light source, NIR handheld camera, and additional components that together, connect to the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from the NIR handheld camera system is displayed on the Tower monitor. Component: Yes, the SOCK is the component and integrated into the dV5 system
    UDI 00886874119662
    400 affected lots
    38074600886874119662D531324470653-011008007100800810080091008010
    +392 more10080111008012100801310080151008016100801710080201008021100802210080241008100100810110081021008104100810510081071008108100810910081121008113100811410081151008116100811710089971008998100990210100291010033101003410100361010272101029610102971010318101031910104491010450101045110104961010497101049810104991010501101058110106181010619101062010106211010633101063410106351010636101063810106401010642101064310106441010645101064610113331011334101133510113361011337101133810113401011362101136310113641011366101137010113711011372101137410113771011378101137910113801011381101138210113831011384101138610113881011389101139010113911011392101139310113941011395101139610120561012057101205810120591012060101206210120631012064101206510120661012068101206910120701012071101207310120751012076101207810120791012080101208110120821012084101208510122841012998101299910130011013002101300310130041013005101300710130081013009101301010130111013012101301310130151013017101301910131081013109101311010131111013112101311310131141013115101311610131171013118101311910131201013121101312210131241013125101312610131271013129101313010131321013491101349210134931013494101349610134971014027101402810140291014030101403110140321014034101403610140371014038101403910141401014143101414610141471014149101415010141511014152101415310141541014155101415610141581014159101416010141631014164101416510141661014167101416810141691014170101417110141731014174101417510141771014178101457410145751014576101457710145781014580101458110145821014583101458410145851014586101458710145891014590101459110145921014594101459510145961014597101459810145991014600101460110146021014603101460410146051014606101460710146081014609101461010146111014612101461310146151014616101461810146191014622101462310146241014721101472210147231014724101472510147261014727101472810147291014730101473110152471015248101525010152511015252101525310152541015255101525610152571015258101525910152601015261101526210152631015264101526610158541015855101611010161111016112101611310161141016115101611710161181016119101612010161221016123101612410161251016126101612710161281016129101613010161361016137101613810161391016140101614110161421016143101614410161501016151101615210161531016154101615510164751016478101647910164801016481101648210164831016484101660110166021016603101660410166051016606101660710166081016791101718110171821017327101732810173291017330101733110173321017333101733410173361017337101733810173401017341101734310173451017346101734710173481017545101754710175491017550101755210175531017555101755610175571017558101756010175611017562101756510175661017569101757010175711017572101757310178671017871101787310178741017875101787810178791017880101788210178841017887101788810178901017891101789310178941017895101789610178981017899101790010179021017903

What the firm is doing

On 04/24/2026, the firm emailed an "Urgent Medical Device Correction" Letter to customers informing them that Intuitive has identified a condition in which the NIR modes may remain active unintentionally when attempting to turn off visible white light illumination during normal clinical workflow transitions, when switching from the handheld camera to the robotic endoscope and may result in thermal injury if the distal end of the light guide (detached) or assembled laparoscope contacts the patient, user, or sterile drapes while NIR mode is active. Customer Actions required for Continued Use of dV5 Systems Equipped with the NIR Handheld Camera: "Prior to each use, ensure that the NIR Handheld Camera Light Source indicators remain visible to operating room staff so that the laser status can be confirmed. Position the dV5 Tower Monitor and other equipment so the Light Source indicators are not obstructed from view. "The Tower Monitor should be positioned to avoid obstructing the Light Source indicators to maintain clear visibility of the CCU during use. Monitor positioning may vary based on Operating Room configuration. Refer to the Near Infrared Handheld Camera System User Manual (PN 557076-02) for additional setup guidance. "The indicators include: - LASER ON status indicator -Laser symbol on the LCD display -Green-colored button backlights "Prior to placing the device on the patient or sterile drapes, confirm that the Light Source is in Standby Mode, as indicated by white-colored button backlights and Standby on the LCD display. "Press and hold the green up arrow button on the Camera Head for approximately 2.5 seconds to deactivate the light source. "Be aware of the following Cautions stated in the Handheld Camera Light Guide IFU (Schoelly s reference: TPA801-460-01; Intuitive s reference: PN 557072-01): For questions/support, Clinical Sales Rep or Intuitive Customer Service at the numbers listed below: "North and South America: (800) 876-1310, Option 3 (4 am

DistributionShow details

U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: Australia, Belgium, France, Germany, Italy, Japan, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, South Korea, Spain, Switzerland, and United Kingdom

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

More Class II recalls