FDA Device recall Z-1527-2014
PolypVac 3.5mm Microdebrider
- FDA Device
- Class III
- terminated
- Published 2014-05-07
On 2014-05-07 the FDA classified a Class III recall of PolypVac 3.5mm Microdebrider by Laurimed, citing the reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1527-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-04-07 |
| Published | 2014-05-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Laurimed |
| Distribution | AZ, CA, FL, ID, IL, NC, OR, PA, TX, VA, VT |
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.
Reason
The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.
Identifiers
| code_info | Lot Number: LFG-111813-1; Expiry date: June 2014; LFG020614-01, Expiry date: September 2014. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1527-2014%22
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