TLS2 Thermal Ligating Shears recalled over fire hazard

Recall date

March 22, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Microline Surgical, Inc. recalls TLS2 Thermal Ligating Shears, Catalog Number 132-131D

Recall number

Z-1698-2019

FDA classification

Class II

Brand / firm

Microline Surgical, Inc.

Sold / distributed

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

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

TLS2 Thermal Ligating Shears, Catalog Number 132-131D