Agency classClass IIOur severity:High FDA (Devices)·Z-1209-2022·Announced 2022-06-08

da Vinci Vessel Sealer May Fail to Adequately Seal Tissue

Intuitive Surgical is recalling da Vinci Vessel Sealer instruments worldwide because placing excessive tissue in the instrument jaws can result in an insufficient seal. Surgeons should follow proper technique guidelines when using the device.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a surgical device with potential for operational failure if improper technique is used. No reported illnesses or injuries are mentioned in the source material. Per the severity rubric, risk-of-harm products without reported injuries are scored as High (3).

Plain-English summary

Intuitive Surgical, Inc. is recalling the VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X and da Vinci Xi models worldwide. The recall affects 140,519 boxes containing 843,113 individual units distributed across the United States and 50+ additional countries and regions.

The device can fail to adequately seal tissue if surgeons place excessive tissue in the instrument jaws prior to sealing and transection. An insufficient seal during surgery could compromise the effectiveness of the procedure.

This Class II recall was issued by the FDA. The affected product can be identified by the UDI code 00886874115664 and covers all production lots.

Healthcare facilities and surgeons using these instruments should review proper technique guidelines to ensure appropriate tissue volume is used during sealing procedures. Contact Intuitive Surgical for additional guidance on proper device use.

The recalled product

Product: VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Manufacturer: Intuitive Surgical, Inc.
Category: Medical Device — Surgical Instrument
Hazard: insufficient-seal

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

UDI: 00886874115664. All lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Intuitive Surgical, Inc.

See all →

Moderate
da Vinci SP Instrument Arm Drape may detach during surgical procedures
FDA (Devices) · 2026-07-22
Severe
Da Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
High
Da Vinci 5 tower may unintentionally activate the infrared handheld camera
FDA (Devices) · 2026-06-10
High
da Vinci X and Xi Surgical Systems Recalled for Manipulator Arm Screw Breakage
FDA (Devices) · 2026-05-13
Severe
Intuitive 8 mm SureForm 30 Gray Reloads Incomplete Staple Defect
FDA (Devices) · 2026-05-13

Same hazard · insufficient seal