CLASS II Device recall · Reported 12 Jun 2019 · FDA Enforcement Report

TLS2 Thermal Ligating Shears recalled by Microline Surgical

Microline Surgical is recalling TLS2 Thermal Ligating Shears, distributed in North Dakota, New York. The recall was initiated on 22 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 811099011439; Lot Numbers: 807118, 807119, 807120, 811076

Quantity recalled115 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-1698-2019
FDA event ID: 82708
Recalling firm: Microline Surgical, Beverly, MA
Classification: Class II
Status: Terminated
Recall initiated: 22 Mar 2019
FDA classified: 31 May 2019
Reported: 12 Jun 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

22 Mar 2019	Recall initiated by company
31 May 2019	Classified by FDA	+70 days
12 Jun 2019	Published in enforcement report	+12 days

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

Reason for recall

The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

TLS2 Thermal Ligating Shears, Catalog Number 132-131D

Where it was distributed

The products were distributed to the following US states: ND and NY. The products were distributed to the following foreign countries: Germany, Netherlands.

North Dakota New York

Questions about this recall

Is TLS2 Thermal Ligating Shears recalled?

Yes. Microline Surgical recalled TLS2 Thermal Ligating Shears on 22 Mar 2019. The recall is Class II and its status is Terminated. Recall number Z-1698-2019.

Why was it recalled?

The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.

Which lots are affected?

UDI: 811099011439; Lot Numbers: 807118, 807119, 807120, 811076

Where was it sold?

The products were distributed to the following US states: ND and NY. The products were distributed to the following foreign countries: Germany, Netherlands.

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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