[pending] Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosur
Pending LLM rewrite. Source: FDA_DEVICE Z-1894-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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 recalled product
- Product
- Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862030.
- Manufacturer
- Silex Medical, LLC
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 0710
- 0711
- 0712
- 0713
- 0714
- 0715
- 0716
- 0717
- 0718
- 0719
- 0720
Distribution
Distributed nationwide across the United States.
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