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Recall Observatory FDA recall evidence

Device product

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

Z-0663-2025

November 05, 2024

Class II

Product summary

Firm
Microline Surgical, Inc.
Event
Event 95734
Status
Ongoing
Classification
Class II
Quantity
200 units
Official record key
device-enforcement:Z-0663-2025

Official wording

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

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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