Reported Jun 11, 2025 · Ongoing
Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch…
Silex Medical, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Silex Medical, LLC · 24 Robert Porter Rd Ste B · Southington, CT · 06489-1158
Is this the product you have?
- Signature Laparoscopic Instruments, Debakey Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector
- Model/REF Number5862100
- Lot codes and dates
- Model/REF Number5862100
- UDI-DIB33158621000
- Lot NumberM28183
- Serial Numbers
19321933193419351936193719381939
- Amount recalled
- 8 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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