Laparoscopic Instrument (Silex) – Insulation Gap (2024)
Incomplete insulation on a medical instrument can potentially expose a non-insulated area of the shaft.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5860020.
Brand
Silex Medical, LLC
Lot Codes / Batch Numbers
Model/REF Number: 5860020. UDI-DI: B33158600200. Lot Number: M28181. Serial Numbers: 0691, 0692.
Products Sold
Model/REF Number: 5860020. UDI-DI: B33158600200. Lot Number: M28181. Serial Numbers: 0691, 0692.
Silex Medical, LLC is recalling Signature Laparoscopic Instruments, Dolphin Nose Grasper with Rotating Shaft and Monopolar Electrosu due to 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 c. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Silex formally notified customers on 01/09/2024. Instructions to consignees included to inspect all instruments that they received from the affected lots for the defect. If any instruments had the issue, the customers were instructed to send it back to their facility under an RGA.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026