ReNew Microscissor Tip Disposable Recalled Due to Heat Shrink Failure
Microline Surgical is recalling ReNew Microscissor Tip (Disposable) lot 00172110 due to a 2% failure rate where the heat shrink breaks off.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of a surgical instrument where a component failure (heat shrink breaking off) poses a risk of harm, though no injuries have been reported to date.
Plain-English summary
Microline Surgical, Inc. is recalling ReNew Microscissor Tip (Disposable) items from lot 00172110 (Microline Catalog #3122, UDI/DI: 811099010036). The recalled product exhibited a 2% failure rate in which the heat shrink breaks off.
Microscissor tips are precision surgical instruments used in various surgical procedures. A heat shrink component breaking off could affect device performance and safety during use.
The affected lot of 200 units was distributed worldwide, including in Oklahoma and Japan.
The recalled product
- Product
- Microscissor Tip (Disposable); Microline Catalog #: 3122.
- Manufacturer
- Microline Surgical, Inc.
- Hazard
- Affected units
- 200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Microline Catalog #: 3122
- UDI/DI: 811099010036
- Lot Number: 00172110.
Distribution
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