Drug recall
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
FDA recall event 98525 · Class I · Intuitive Surgical, Inc.
Key facts
| Event ID | 98525 |
|---|---|
| Recall numbers | Z-1855-2026 |
| Recalling firm | Intuitive Surgical, Inc. |
| Product type | Devices |
| Products | Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06 |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Reloads for curved-tipped stapler may potentially produce an incomplete staple line. |
| Initiation date | Mar 11, 2026 |
| Report date | May 13, 2026 |
| City | Sunnyvale |
| State | CA |
| Country | United States |
| FEI number | 3001675293 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: