Class II U.S. Food and Drug Administration

Intuitive Surgical, Inc. Da Vinci 5 Assy, DV5 Console, IS5000 Model/ recall: An error event following the release of a software version for the surgical

Recall published 8 months ago

An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1428-2026
Published
February 25, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Intuitive Surgical, Inc.
Product type
Medical devices
Units affected
12
Distribution
Louisiana, Massachusetts, New York, Pennsylvania, Texas, Virginia
Made in
United States
Lot / code info
UDI-DI: 00886874119747 GTIN: 0886874119747 with software version P1.2.1
UPC codes
0886874119747, 00886874119747

Products covered by this recall

Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery.

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 0886874119747
  • 00886874119747

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Intuitive Surgical, Inc. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: Intuitive Surgical, Inc. — 1266 Kifer Rd, Sunnyvale, CA, 94086-5304

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Intuitive Surgical, Inc. medical devices recalled?

An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor. An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 0886874119747, 00886874119747. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Which states were affected?

The notice lists Louisiana, Massachusetts, New York, Pennsylvania, Texas, Virginia.

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