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RecallWatchMedical Device Safety
Class IIOngoingZ-1096-2026

Intuitive Surgical, Inc. recalls da Vinci SP

Intuitive Surgical, Inc.Sunnyvale, CA, United StatesReported Jan 21, 2026 · 5 months ago
Legal News Analyst ·

Reason for recall

Access Port System tray may develop cracks potentially resulting in a sterility breach.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)REF
    UDI 00886874119549REF 430073
    151 affected lots
    U80240110K10250114K10250305K10250306K10250313K10250414K10250424K10250514
    +143 moreK10250522K10250619K10250626K10250629K10250630K10250710K10250716K10250717K10250731K10250804K10250806K10250828K10250904K11250113K11250807K11250821K11250828K11250911K12250821U10241101U10241115U10250108U10250207U10250210U10250307U10250310U10250313U10250321U10250325U10250331U10250414U10250425U10250506U10250509U10250521U10250528U10250604U11241101U11241121U11241210U11250123U11250219U11250404U11250425U11250521U12250219U80231207U80231219U80240118U80240125U80240201U80240222U80240306U80240319U80240402U80240411U80240417U80240523U80240617U80240620U80240806U80240812U80240905U80240911U80241017U80241025U81231219U81240118U81240125U81240306U81240319U81240402U81240411U81240417U81240617U81240620U81240627U81240806U81240905U81240911U8223121943007500886874119556U81240125U80240201U80240222U80240125U81240215U81240208U80240208U81240201U81240229U80240326U80240529U80240229U81240222U80240711U81240606U80240606U80240812U80240731U80240917U10241107U80241003U10241217U10250123U10250305U10250219U10250102K10250313U10250414U10250423K10250529K10250522U10250529K10250701K10250702K10250717K11250814K10250807K11250813K10250605U80240611K10250327U80240425U10250312K10250515K11250515U10250318U80240724U10250115U10250326U80240130U80240627K10250113K11250529K10250723U80240717U80240215U10250501K10250403U10250515K12250904

What the firm is doing

On December 15, 2025, Intuitive Surgical Inc. issued a Urgent: Medical Device Recall Notification via mail and email. Intuitive asked consignees to take the following actions: 1. Follow the warning provided in the SP Access Port Kit User Manual Addendum 2. Identify Affected Product: Please inspect the product label to confirm the Part Number and Lot Number. 3. If the product label indicates a Lot Number within the affected range specified, proceed with the following actions 4 and 5 below. 4. Quarantine affected inventory: Immediately segregate and quarantine all affected units to prevent clinical use. 5. Return affected product. 6. Forward this notice to all individuals within your organization who need to be aware. 7. Complete the attached Acknowledgement Form immediately and return it to Intuitive via fax or email as instructed on the form. 8. Please retain a copy of this letter, place a copy with your affected system, and keep the acknowledgement form for your files. 9. Please inform Intuitive of any Adverse Events*/Serious Incidents** or quality problems. 10. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

DistributionShow details

Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Poland, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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