FDA recall Z-0663-2025

Microline Surgical, Inc. · Class II · device

Product

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

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

Key facts

Status
Ongoing
Initiation date
2024-11-05
Report date
2024-12-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Beverly, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0663-2025