Signature Laparoscopic Debakey Grasper Instruments Recalled for Insulation Defect
Silex Medical is recalling 8 units of Signature Laparoscopic Debakey Grasper instruments (Model 5862100) due to incomplete insulation on the shaft near the rotator wheel, which could expose the user or patient to electrical contact.
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: This is an FDA Class II recall of a surgical instrument with a potential electrical hazard and risk of injury (electrical contact during use) where no injuries have yet been reported. The hazard is substantive but theoretical; the incomplete insulation creates a risk of harm rather than confirmed illness or injury, placing it at the High severity level.
Plain-English summary
Silex Medical, LLC is recalling Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector, Model/REF Number 5862100. The recall affects 8 units distributed nationwide to Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, and Hawaii.
The defect involves incomplete insulation on the tube, which does not extend fully to the proximal end of the shaft on the instrument. This leaves an exposed (not insulated) area of the shaft closer to the rotator wheel, creating a potential electrical hazard during surgical use.
Affected units are identified by Lot Number M28183 and Serial Numbers 1932 through 1939. The product UDI-DI is B33158621000. Users who possess these instruments should contact Silex Medical, LLC for instructions on replacement or return of the recalled devices. No instructions for home disposal are indicated in this notice.
The recalled product
- Product
- Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862100.
- 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 (7)
- 1933
- 1934
- 1935
- 1936
- 1937
- 1938
- 1939.
Distribution
Distributed nationwide across the United States.
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