CLASS II ONGOING Device recall · Reported 11 Jun 2025 · FDA Enforcement Report

Signature Laparoscopic Instruments, Allis Clamp Grasper recalled

Silex Medical is recalling Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar, distributed nationwide in the US. The recall was initiated on 9 Jan 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel/REF Number: 5862030. UDI-DI: B33158620300. Lot Number: M28182. Serial Numbers: 0709, 0710, 0711, 0712, 0713, 0714, 0715, 0716, 0717, 0718, 0719, 0720

Quantity recalled10 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1894-2025
FDA event ID: 96755
Recalling firm: Silex Medical, Southington, CT
Classification: Class II
Status: Ongoing
Recall initiated: 9 Jan 2024
FDA classified: 2 Jun 2025
Reported: 11 Jun 2025
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

9 Jan 2024	Recall initiated by company
2 Jun 2025	Classified by FDA	+510 days
11 Jun 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF Number: 5862030.

Where it was distributed

US Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii.

Nationwide California Connecticut Florida Hawaii Iowa Idaho Illinois Michigan Mississippi North Dakota New Jersey Oregon Texas Virginia West Virginia

Questions about this recall

Is Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar recalled?

Yes. Silex Medical recalled Signature Laparoscopic Instruments, Allis Clamp Grasper with Rotating Shaft and Monopolar on 9 Jan 2024. The recall is Class II and its status is Ongoing. Recall number Z-1894-2025.

Why was it 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.

Which lots are affected?

Model/REF Number: 5862030. UDI-DI: B33158620300. Lot Number: M28182. Serial Numbers: 0709, 0710, 0711, 0712, 0713, 0714, 0715, 0716, 0717, 0718, 0719, 0720

Where was it sold?

US Nationwide distribution in the states of Florida, North Dakota, Illinois, California, Texas, Virginia, Michigan, Connecticut, Oregon, Iowa, Mississippi, New Jersey, Idaho, West Virginia, Hawaii.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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