Recall Z-1855-2026— Intuitive Surgical, Inc.
Class I · Ongoing
Class I FDA medical device recall by Intuitive Surgical, Inc., initiated 2026-03-11. It names 3 FDA 510(k) clearances: K241638, K222839, K211997. Product: Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06. Reason: Reloads for curved-tipped stapler may potentially produce an incomplete staple line..
- Recalling firm
- Intuitive Surgical, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2026-03-11
- Firm location
- Sunnyvale, CA, United States
510(k) clearances named in this recall
3 on FDA's record- K241638 — 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads
- K222839 — EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System
- K211997 — 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Reason for recall
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
Data sourced from openFDA. This site is unofficial and independent of the FDA.