Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive...
FDA Device Recall #Z-0110-2014 — Class II — October 2, 2013
Recall Summary
| Recall Number | Z-0110-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 2, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Intuitive Surgical, Inc. |
| Location | Sunnyvale, CA |
| Product Type | Devices |
| Quantity | 286 boxes ( 6 instruments per box) for a total of 2,220 affected clinical product |
Product Description
Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port. 2.
Reason for Recall
A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication, warnings and precautions.
Distribution Pattern
Worldwide distribution: US (nationwide) and countries of:Australia, Belgium, France, Italy and United Kingdom. .
Lot / Code Information
Model number 428080-04 All distribution from 3-15-13 to 7-19-13. Batch/Lot # S10130510 S10130325 S10130314 S10130314 S10130415 S10130426 S10130329 S10130228 S10130418 S10130304 S10130418 S10130325 S10130325 S10130408 S10130408 S10130510 S10130415 S10130304 S10130314 S10130415 S10130418 S10130228 S10130329 S10130329 S10130415 S10130426 S10130426 S10130426 S10130408 S10130325 S10130228 S10130325 S10130426 S10130426 S10130418 S10130325 S10130510 S10130408 S10130415 S10130408 S10130228 S10130304 S10130418 S10130415 S10130426 S10130314 S10130426 S10130418 S10130228 S10130228 S10130304 S10130415 S10130415 S10130418 S10130408 S10130329 S10130314 S10130228 S10130228 S10130314 S10130325 S10130415 S10130426 Batch/Lot # S10130426 S10130418 S10130408 S10130325 S10130415 S10130415 S10130415 S10130418 S10130325 S10130325 S10130329 S10130325 S10130314 S10130329 S10130426 S10130314 S10130408 S10130329 S10130426 S10130426 S10130325 S10130415 S10130426 S10130426 S10130325 S10130325 S10130325 S10130329 S10130329 S10130408 S10130415 S10130408 S10130408 S10130415 S10130415 S10130418 S10130426 S10130415 S10130325 S10130408 S10130418
Other Recalls from Intuitive Surgical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1355-2026 | Class II | da Vinci 5 Surgeon Console Viewer Display, ASSY... | Dec 30, 2025 |
| Z-1096-2026 | Class II | da Vinci SP, SP Access Port Kit, Large Incisio... | Dec 15, 2025 |
| Z-1134-2026 | Class II | Brand Name: Ion Endoluminal System Product Nam... | Dec 4, 2025 |
| Z-1428-2026 | Class II | Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/... | Nov 17, 2025 |
| Z-1232-2026 | Class II | Brand Name: Da Vinci Product Name: da Vinci X,... | Nov 7, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.