FDA recall, , High risk
Intuitive 8 mm SureForm 30 Gray Reloads
The reloads may potentially produce an incomplete staple line.
Summary by Recall Canary from the FDA notice
What happened
Intuitive Surgical, Inc. of Sunnyvale, California recalled Intuitive 8 mm SureForm 30 Gray Reloads, Reference Numbers 48230M-05 and 48230M-06, beginning March 11, 2026, because the reloads may potentially produce an incomplete staple line. The FDA added the recall to its Enforcement Report and classified it on May 1, 2026.
The reloads were distributed in US states and in Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Netherlands, Norway, Spain, Sweden, Switzerland, and 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 matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
- UDI-DI
- 00886874121931
- Lot code
- All serial Numbers
Recall details
- Company began the recall
- Sold in
US: Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin OUS: Austria Belgium Denmark Finland France Germany Ireland Italy Japan Netherlands Norway Spain Sweden Switzerland United Kingdom
- Company
- Intuitive Surgical, Inc.Sunnyvale, California
- Hazard
- Device defect
- Risk
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
- Event ID
- 98525
- Recall number
- Z-1855-2026
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
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
