Recall Z-1855-2026 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
| Date | May 1, 2026 (initiated Mar 11, 2026) |
| Status | Open, Classified |
| Reason | Reloads for curved-tipped stapler may potentially produce an incomplete staple line. |
| Root cause | Under Investigation by firm |
| Action | On 3/17/2026 Intuitive Surgical issued a "urgent Medical Device Recall Notification to affected consignees via E.Mail and FedEx. Intuitive ask consignees to take the following actions: 1. Please identify, discontinue use, and quarantine any affected product(s). Affected product(s) may be returned by calling customer service with quantities and lot numbers to your regional customer service. 2. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 3. Please ensure to include the Recall or FSCA number ISIFA2026-02-R in yo |
| Distribution | 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 Mex |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211997 | 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads Intuitive Surgical, Inc., Dec 10, 2021 |
| K222839 | EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 Syste Intuitive Surgical, Inc., Mar 16, 2023 |
| K241638 | 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 Reloads Intuitive Surgical, Inc., Sep 10, 2024 |