Recall archive / FDA device enforcement
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06 — FDA record Z-1855-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 11, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
- Reason
- Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
- Classification
- Class I
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- Not supplied
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1855-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI:00886874121931/All serial Numbers |
Match all identifying details in the current notice. A brand name alone is not enough.
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
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
Dates in the source
- Report date
- May 13, 2026
- Recall initiation date
- Mar 11, 2026
- Center classification date
- May 1, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.