Intuitive Da Vinci Stapler Instruments Recalled for Potential Staple Deployment Failure
Intuitive Surgical is recalling Da Vinci Xi surgical stapling instruments due to potential staple deployment failure and device fragment generation. No injuries have been reported.
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 a Class II medical device recall of surgical instruments with potential for serious harm during use. However, the source text does not report any injuries or illnesses, and the hazard is characterized as 'potential.' Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Intuitive Surgical, Inc. is recalling specific models of Da Vinci Xi 8mm SureForm 30 curved-tip staplers and reloads used in minimally invasive surgery. The recall affects 960 individual instruments and 7,224 reloads distributed across 23 U.S. states.
The devices are being recalled due to potential staple deployment failure and device fragment generation. These defects could occur during surgical procedures and compromise the intended function of the instruments.
The affected products were distributed to healthcare facilities in Arizona, California, Colorado, Florida, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin. The FDA has not received reports of patient injury or illness related to this issue.
Healthcare providers should immediately cease use of affected instruments and reloads. Facilities should contact Intuitive Surgical for instructions on device return or replacement.
The recalled product
- Product
- INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm…
- Manufacturer
- Intuitive Surgical, Inc.
Distribution
Related recalls
Same manufacturer · Intuitive Surgical, Inc.
See all →- Moderateda Vinci SP Instrument Arm Drape may detach during surgical procedures
FDA (Devices) · 2026-07-22
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- HighDa Vinci 5 tower may unintentionally activate the infrared handheld camera
FDA (Devices) · 2026-06-10
- Highda Vinci X and Xi Surgical Systems Recalled for Manipulator Arm Screw Breakage
FDA (Devices) · 2026-05-13
- SevereIntuitive 8 mm SureForm 30 Gray Reloads Incomplete Staple Defect
FDA (Devices) · 2026-05-13
Similar recalls
- SevereIntuitive Surgical Recalls da Vinci EndoWrist Stapler 30 Instruments
FDA (Devices) · 2016-09-07
- ModerateIntuitive Surgical Recalls da Vinci Xi Stapler Release Kits Due to Instruction Errors
FDA (Devices) · 2017-04-12
- ModerateIntuitive Surgical Recalls da Vinci Xi Stapler Release Kits Due to Instruction Issues
FDA (Devices) · 2017-04-12
- HighIntuitive Surgical Recalls da Vinci Xi Stapler Reloads Due to Missing Component
FDA (Devices) · 2018-07-18
- LowIntuitive Surgical Recalls da Vinci Xi Stapler Release Kits
FDA (Devices) · 2017-04-12
- SevereIntuitive Surgical da Vinci EndoWrist Stapler 45 Recall for Field Failures
FDA (Devices) · 2016-09-07