Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | High |
| Status | ongoing |
| Recall date | March 11, 2026 |
| Reported | May 13, 2026 |
| Recalling firm | Intuitive Surgical, Inc. |
| Country / region | United States CA |
Hazard
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
Affected products
- Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
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