The Recall Desk
HighFDA (Devices)·Z-1890-2020·Announced 2020-05-13

Intuitive Surgical Recalls daVinci XI Sureform Stapler Reloads Due to Deployment Defect

Intuitive Surgical is recalling 22,752 daVinci XI Sureform 60 reloads worldwide because a manufacturing variation may prevent adjacent staples from deploying, potentially causing an incomplete staple line.

What this means for you

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: The recall is classified as FDA Class II. The hazard involves a risk of harm (air leak or anastomotic leak requiring additional intervention) in a medical device, but the source text does not report any specific illnesses, injuries, or fatalities, fitting the criteria for a High severity score.

Plain-English summary

Intuitive Surgical, Inc. is recalling 22,752 units of the daVinci XI Sureform 60 reload, 60 mm Green 6-Row, 4.6 mm (REF 48360G-08). The affected products are sterile, ethylene oxide-sterilized surgical stapler reloads intended for use with da Vinci Surgical Systems for resection, transection, or creation of anastomoses in general, thoracic, gynecologic, urologic, and pediatric surgery.

The recall was initiated because the firm identified a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples. This defect could result in an incomplete staple line. An incomplete staple line could potentially lead to an air leak or an anastomotic leak, which may require an additional procedural intervention.

The affected products were distributed worldwide, including nationwide in the United States and in specific countries such as Australia, the Czech Republic, Denmark, Finland, France, Germany, Italy, Japan, Luxembourg, the Netherlands, Norway, South Korea, Spain, Switzerland, and the United Kingdom. The recall covers specific lot numbers, including T10180511, T10180718, T10180821, T10180822, T10180906, T10180913, T10180925, T10181008, T10190204, T10190208, T10190213, T11180816, and T11190219. Healthcare providers and facilities should check their inventory for these specific lot numbers and contact the manufacturer for instructions on returning the affected devices.

The recalled product

Product
daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI: 00886874113844, Rx Only, Sterile EO - Product Usage: are intended to be used with da Vinci Surgical Systems for resection, transection, and, or creation of anastomoses in General, Thoracic, Gynecologi
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Stapler Reload
Hazard
Affected units
22,752

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 (13)

  • Lot numbers: T10180511
  • T10180718
  • T10180821
  • T10180822
  • T10180906
  • T10180913
  • T10180925
  • T10181008
  • T10190204
  • T10190208
  • T10190213
  • T11180816
  • T11190219

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

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 →

Related recalls

Same manufacturer · Intuitive Surgical, Inc.

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Same hazard · incomplete staple line

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