Home / Recalls / Microline Surgical, Inc. / Z-0663-2025

Z-0663-2025 Class II Ongoing

Recalled by Microline Surgical, Inc. — Beverly, MA

Recall Details

Product Type
Devices
Report Date
December 18, 2024
Initiation Date
November 5, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
200 units

Product Description

Microscissor Tip (Disposable); Microline Catalog #: 3122.

Reason for Recall

A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off.

Distribution Pattern

Worldwide - US Nationwide in the state of OK and the country of Japan.

Code Information

Microline Catalog #: 3122; UDI/DI: 811099010036; Lot Number: 00172110.

Other recalls by Microline Surgical, Inc.

  • Z-1698-2019 Class II — TLS2 Thermal Ligating Shears, Catalog Number 132-131D (March 22, 2019)
  • 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)