Summary
The FDA issued a Class II for Microscissor Tip (Disposable); Microline Catalog #: 3122. by Microline Surgical, Inc.. Reason: A lot of ReNew Microscissor Tips exhibited a 2% rate of failure in terms of the heat shrink breaking off..
Details
Source
Device Recall
External ID
Z-0663-2025
Action Date
2024-12-18
Status
Ongoing
Category
device
Product Description
Microscissor Tip (Disposable); Microline Catalog #: 3122.
Lot/Code Info: Microline Catalog #: 3122; UDI/DI: 811099010036; Lot Number: 00172110.
Quantity Affected: 200 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-11-05
Company
Beverly, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 184 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Microline Surgical, Inc. has 3 FDA actions in our database, including 1 recall and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Microline Surgical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Microline Surgical, Inc. have FDA actions?
Microline Surgical, Inc. has 3 FDA actions in our database, including 1 recall and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0663-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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