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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
- Hazard
- incomplete-staple
- surgical-device-malfunction
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
Distribution scope not specified by the agency.