da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,
FDA device recall Z-1096-2026 · posted 2026-01-15 · Open, Classified
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Access Port System tray may develop cracks potentially resulting in a sterility breach.
- Action taken
- 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.
- Root cause
- Packaging change control
- Status
- Open, Classified
- Product code
- NAY
- Quantity affected
- 41,526 units
- Distribution
- Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Ma
- Date initiated
- 2025-12-15
- Date posted
- 2026-01-15
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories (K202571) | Intuitive Surgical, Inc. | 2020-11-12 |