Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

PolypVac 3.5mm Microdebrider Recalled by Laurimed LLC Due to The reciprocation mechanism in the PolypVac Microdebrider may...

Date: April 7, 2014
Company: Laurimed LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Laurimed LLC directly.

Affected Products

PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.

Quantity: 58

Why Was This Recalled?

The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.

Where Was This Sold?

This product was distributed to 11 states: AZ, CA, FL, ID, IL, NC, OR, PA, TX, VT, VA

Affected (11 states)Not affected

About Laurimed LLC

Laurimed LLC has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report