Z-1897-2025 Class II Ongoing
FDA device recall Z-1897-2025 was initiated by Silex Medical, LLC on January 9, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 11, 2025
- Initiation Date
- January 9, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030.
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.
Code Information
Model/REF Number: 5863030. UDI-DI: B33158630300. Lot Number: M28185. Serial Numbers: 0446, 0447, 0448, 0449, 0450, 0451.