Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electro...
FDA Device Recall #Z-1894-2025 — Class II — January 9, 2024
Recall Summary
| Recall Number | Z-1894-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 9, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Silex Medical, LLC |
| Location | Southington, CT |
| Product Type | Devices |
| Quantity | 10 units |
Product Description
Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862030.
Reason for Recall
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
Distribution Pattern
US Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii.
Lot / Code Information
Model/REF Number: 5862030. UDI-DI: B33158620300. Lot Number: M28182. Serial Numbers: 0709, 0710, 0711, 0712, 0713, 0714, 0715, 0716, 0717, 0718, 0719, 0720
Other Recalls from Silex Medical, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1897-2025 | Class II | Signature Laparoscopic Instruments, Bullet Tip ... | Jan 9, 2024 |
| Z-1895-2025 | Class II | Signature Laparoscopic Instruments, Debakey Gra... | Jan 9, 2024 |
| Z-1896-2025 | Class II | Signature Laparoscopic Instruments, Sharp Tooth... | Jan 9, 2024 |
| Z-1893-2025 | Class II | Signature Laparoscopic Instruments, Dolphin Nos... | Jan 9, 2024 |
| Z-1899-2025 | Class II | Signature Laparoscopic Instruments, Atraumatic ... | Jan 9, 2024 |
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.