Home / Recalls / Microline Surgical, Inc. / Z-1698-2019

Z-1698-2019 Class II Terminated

Recalled by Microline Surgical, Inc. — Beverly, MA

Recall Details

Product Type
Devices
Report Date
June 12, 2019
Initiation Date
March 22, 2019
Termination Date
July 30, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
115 units

Product Description

TLS2 Thermal Ligating Shears, Catalog Number 132-131D

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.

Distribution Pattern

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

Code Information

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

Other recalls by Microline Surgical, Inc.

  • Z-0663-2025 Class II — Microscissor Tip (Disposable); Microline Catalog #: 3122. (November 5, 2024)
  • Z-1741-2018 Class II — ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115 (November 1, 2017)
  • Z-1740-2018 Class II — ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099 (November 1, 2017)
  • Z-0507-2018 Class II — The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Lapa (July 13, 2017)
  • Z-1986-2014 Class II — Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips Ref 3221 (May 12, 2014)
  • Z-1987-2014 Class II — Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips (Reusable) (May 12, 2014)
  • Z-1635-2014 Class II — Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Num (April 14, 2014)