FDA Class II Recall: Brand Name: Da Vinci 5 Product Name: ASSY,DV5… by Intuitive Surgical, Inc. — Recall Details

Key facts

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- 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 (additional items listed in FDA's full record) -- and the recall number Z-2310-2026. If it matches, stop using or distributing it and contact Intuitive Surgical, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Intuitive Surgical, Inc. and the affected product is described in FDA's record as: 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 (additional items listed in FDA's full record). FDA's stated reason for the recall is: 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.. The recall is tracked under FDA recall number Z-2310-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Intuitive Surgical, Inc.’s FDA history

Argus HQ has recorded 4 total FDA actions tied to Intuitive Surgical, Inc.: 0 warning letters, 4 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (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 (additional items listed.

Has Intuitive Surgical, Inc. had other FDA recalls or enforcement actions?

Yes. Argus HQ has recorded 4 total FDA actions tied to Intuitive Surgical, Inc., including 4 recalls and 0 warning letters.

What is the FDA recall number for this event?

FDA recall number Z-2310-2026.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Related enforcement actions