Recall Z-0663-2025— Microline Surgical, Inc.

Name: FDA recall Z-0663-2025
Creator: U.S. Food and Drug Administration
Published: 2024-11-05

Class II · Ongoing

Class II FDA medical device recall by Microline Surgical, Inc., initiated 2024-11-05. It names one FDA 510(k) clearance: K213127. Product: Microscissor Tip (Disposable); Microline Catalog #: 3122.. Reason: A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off..

Recalling firm: Microline Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-11-05
Firm location: Beverly, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K213127 — ReNew Disposable Scissor TipsMicroline Surgical, Inc.·cleared 2022-03-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.