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U.S. Department of Health and Human Services

Class 2 Device Recall Signature Laparoscopic Instruments

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 Class 2 Device Recall Signature Laparoscopic Instrumentssee related information
Date Initiated by FirmJanuary 09, 2024
Date PostedJune 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1897-2025
Recall Event ID 96755
510(K)NumberK914910 
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
ProductSignature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5863030.
Code Information Model/REF Number: 5863030. UDI-DI: B33158630300. Lot Number: M28185. Serial Numbers: 0446, 0447, 0448, 0449, 0450, 0451.
Recalling Firm/
Manufacturer		 Silex Medical, LLC
24 Robert Porter Rd Ste B
Southington CT 06489-1158
For Additional Information ContactEsteban Lara
1-860-6213223
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Process control
ActionSilex 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.
Quantity in Commerce6 units
DistributionUS Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = GEI
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