Signature Laparoscopic Bullet Tip Grasper Instrument Insulation Defect Recall
Silex Medical is recalling 6 units of the Signature Laparoscopic Bullet Tip Grasper with Rotating Shaft due to incomplete insulation on the shaft near the rotator wheel, which could expose users to electrical hazards.
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: FDA Class II with a risk-of-harm defect (electrical hazard from uninsulated conductor during surgical use). No reported injuries or illnesses are stated in the source, and the hazard is potential rather than realized, keeping the score at High (3) rather than Severe (4).
Plain-English summary
Silex Medical, LLC is recalling 6 units of the Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector (Model/REF Number 5863030) that were distributed nationwide. The defect involves incomplete insulation on the tube; the insulation does not extend fully to the proximal end of the shaft, leaving an exposed (uninsulated) area of the shaft closer to the rotator wheel.
This insulation gap creates a potential electrical hazard during surgical use. The affected units were manufactured under Lot Number M28185, with Serial Numbers 0446, 0447, 0448, 0449, 0450, and 0451, and were distributed to healthcare facilities across 15 states including Florida, California, Texas, New York, Illinois, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, and Hawaii.
Users of this instrument should discontinue use immediately and contact Silex Medical, LLC for instructions regarding the recall and replacement of the affected devices.
The recalled product
- Product
- Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030.
- Manufacturer
- Silex Medical, LLC
- Hazard
- electrical-hazard
- insulation-defect
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 (5)
- 0447
- 0448
- 0449
- 0450
- 0451.
Distribution
Distributed nationwide across the United States.
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