FDA recall, , Moderate risk
Intuitive Surgical da Vinci SP Instrument Arm Drape
The da Vinci SP Instrument Arm Drape may detach from the instrument arm, exposing a section and causing procedure delay or conversion.
Summary by Recall Canary from the FDA notice
What happened
Intuitive Surgical, Inc., of Sunnyvale, California, recalled the da Vinci SP Instrument Arm Drape, SP, 1-PACK, because the drape rings at the top of the product may detach from the instrument arm, exposing a section and possibly causing procedure delay or conversion to an alternate minimally invasive approach.
The FDA added the recall to its Enforcement Report on July 10, 2026, and classified it that same day. The recall began on May 12, 2025, and was reported retrospectively. Distribution included US states such as New Jersey, Oregon, New York, and Florida, and countries including Germany, Sweden, and the United Kingdom.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI, lot code and part code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
da Vinci SP Instrument Arm Drape, SP, 1-Pack
- UDI-DI
- 00886874113486
- Part code
- 430013-13
- 430013-15
- Lot code
- 3074LA0500
- 1124LA0200
- 2124LA0400
- 1134LA0700
- 1144LA0500
- 7154LA0200
- 6164LA0800
- 1084LA0300
- 3164LAA800
- 4084LA0500
- 4124LA0600
- 1274LA0500
- 2294LA0200
- 1274LA0400
- 4284LA0800
- 6324LA0200
- 1324LA0300
- 4154LA0400
- 2284LA0100
- 4144LA1300
- 3324LA0500
- 2354LA0500
- 7144LA0500
- 4294LA0700
- 3374LA0400
- 5264LA0700
- 3224LA0500
- 3424LA0200
- 1394LA0100
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of New Jersey, Oregon, New York, Florida, Alabama, South Dakota, Texas, Virginia, West Virginia, Pennsylvania, California, Washington, Connecticut, Massachusetts, Illinois, Oklahoma, Ohio, Michigan, North Carolina, Missouri, Kentucky, Wisconsin, Arizona, Colorado, Georgia, Maryland, South Carolina, Indiana, Nevada, Tennessee, Mississippi, Kansas, Iowa, Utah, Minnesota, Louisiana, Nebraska, Maine and the countries of Germany, Sweden, United Kingdom, Italy, Belgium, Switzerland, Denmark, Japan, South Korea, Hong Kong, Taiwan, France, Ireland, Spain.
- Company
- Intuitive Surgical, Inc.Sunnyvale, California
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98890
- Recall number
- Z-2722-2026
All recalls from Intuitive Surgical, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
