FDA Medical Device Recalls (openFDA)
Laurimed LLC: 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.
- Recall number
- Z-1527-2014
- Recalling firm
- Laurimed LLC
- Product
- 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.
- Status
- Terminated
- Initiated
- 2014-04-07
- Posted
- 2014-04-30
- Terminated
- 2014-05-14
- Reason
- The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.
- Root cause
- Component design/selection
- Action
- All direct accounts were notified on April 8, 2014 with an Urgent: Medical Device Recall of PolypVac Microdebrider letter, sent by first class mail. The letter identified the affected product, the reason for the recall, and stated that the firm is in the process of implementing corrections. The firm is requesting that all unused lots be returned to them. Replacement devices will sent to customers. In addition, customers are to complete the attached Lot Information sheet. Questions should be directed to bdubois@laurimed.com or 650-587-5296.
- Quantity
- 58
- Distribution
- Distributed in the states of CA, VT, NC, DO, TX, FL, PA, OR, AZ, IL, ID, and VA.
- Lot, serial or model codes
- Lot Number: LFG-111813-1; Expiry date: June 2014; LFG020614-01, Expiry date: September 2014.
- 510(k) numbers
- ["K133133"]
- PMA numbers
- not on file
- Product code
- ERL
- Firm FEI
- 3007209822
- Firm city
- Redwood City
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28