Intuitive 8 mm SureForm 30 Gray Reloads Incomplete Staple Defect
Intuitive Surgical is recalling Intuitive 8 mm SureForm 30 Gray Reloads (Reference Numbers 48230M-05 and 48230M-06) because they may produce an incomplete staple line during curved-tipped stapler operations.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text indicates an FDA Class I classification. Per the rubric, FDA Class I recalls are never scored below 4, and this product is a surgical stapling device where incomplete staple lines pose risk of adverse surgical outcomes.
Plain-English summary
Intuitive Surgical, Inc. is recalling Intuitive 8 mm SureForm 30 Gray Reloads with Reference Numbers 48230M-05 and 48230M-06. These reloads for curved-tipped staplers may potentially produce an incomplete staple line during use.
The affected devices were distributed throughout the United States and internationally to Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Japan, the Netherlands, Norway, Spain, Sweden, Switzerland, and the United Kingdom. All serial numbers of the recalled product are included in this recall.
Users of the affected reloads should discontinue use and contact Intuitive Surgical, Inc. for guidance on replacement or return of the product. Healthcare facilities using these reloads should verify that they do not have affected units in inventory.
The recalled product
- Product
- Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
- Manufacturer
- Intuitive Surgical, Inc.
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:00886874121931/All serial Numbers
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
- Highda Vinci double fenestrated grasper recalled over broken grip cables
FDA (Devices) · 2026-04-08
Similar recalls
- HighIntuitive Surgical Recalls daVinci XI Sureform 60 Reloads Due to Staple Deployment Issues
FDA (Devices) · 2020-05-13
- HighIntuitive Da Vinci Stapler Instruments Recalled for Potential Staple Deployment Failure
FDA (Devices) · 2022-12-07
- HighIntuitive Surgical Recalls daVinci XI Sureform Stapler Reloads Due to Deployment Defect
FDA (Devices) · 2020-05-13
- HighIntuitive Surgical Needle Driver Recall Due to Grip Cable Failures
FDA (Devices) · 2025-01-22
- HighIntuitive Surgical Recalls da Vinci Xi Stapler Reloads Due to Missing Component
FDA (Devices) · 2018-07-18
- SevereRecall of Covidien Signia Stapler Reloads Due to Safety Interlock Failure
FDA (Devices) · 2021-04-21