FDA DevicesClass I
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230...
Published: May 13, 2026Recall ID: Z-1855-2026Category: devicesCountry: US
Reason for Recall / Hazard
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
Product Description & Identification
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Affected Products
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Additional Source Details
| Field | Value |
|---|---|
| City | Sunnyvale |
| State | CA |
| Event id | 98525 |
| Address 1 | 1266 Kifer Rd |
| Code info | UDI:00886874121931/All serial Numbers |
| Postal code | 94086-5304 |
| Report date | 20260513 |
| Product type | Devices |
| Reason for recall | Reloads for curved-tipped stapler may potentially produce an incomplete staple line. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260311 |
| Initial firm notification | |
| Center classification date | 20260501 |
Overview
- Recalling FirmIntuitive Surgical, Inc.
- StatusOngoing
- Risk LevelClass I
- DistributionUS: 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 Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin OUS: Austria Belgium Denmark Finland France Germany Ireland Italy Japan Netherlands Norway Spain Sweden Switzerland United Kingdom