FDAClass I · Medical device · Recalled May 13, 2026
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers recall — Intuitive Surgical, Inc.
Hazard: Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
Class I: most serious — reasonable probability of serious health consequences or death.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-1855-2026
- Brand
- Intuitive Surgical
- Classification
- Class I
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Affected products
Companies & origin
- Recalling firm location
- Sunnyvale, CA, United States
- Firm address
- 1266 Kifer Rd, 94086-5304
Identifying details (verbatim from the notice)
- Product codes / lots
- UDI:00886874121931/All serial Numbers
- 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 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
- Firm notified the public via
- E-Mail
- FDA event ID
- 98525
- Recall initiated
- March 11, 2026
- FDA classified
- May 1, 2026
- FDA report date
- May 13, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.
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