Intuitive Surgical, Inc. medical device recall: Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05…
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 98525
- Recall initiated
- Mar 11, 2026
- Classified by FDA
- May 1, 2026
- Posted in Enforcement Report
- May 13, 2026
- Recalling firm
- Intuitive Surgical, Inc.
- Firm location
- Sunnyvale, CA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Reloads for curved-tipped stapler may potentially produce an incomplete staple line.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Mar 11, 2026. FDA classified it 51 days later, on May 1, 2026. Distribution reported by FDA: 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… Intuitive Surgical, Inc. has 105 recalls in our records.
Recalled products (1)
Z-1855-2026 Class I Ongoing
Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06
Codes / lots: UDI:00886874121931/All serial Numbers
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 98525
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.