FDA Medical devices recall ·
Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft… recall
- Recall number
- Z-1897-2025
- Date
- (initiated January 9, 2024)
- Company / brand
- Silex Medical, LLC
24 Robert Porter Rd Ste B, Southington, CT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model/REF Number: 5863030. UDI-DI: B33158630300. Lot Number: M28185. Serial Numbers: 0446, 0447, 0448, 0449, 0450, 0451.
Distribution
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.
States: California Connecticut Florida Hawaii Iowa Idaho Illinois Michigan Mississippi North Dakota New Jersey Oregon Texas Virginia West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1897-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.