PolypVac 3 — Class III medical device recall Z-1527-2014
Terminated recall by Laurimed LLC, reported 2014-05-07, distributed in AZ, CA, FL, ID, IL, NC, OR, PA…. The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure
| Recall number | Z-1527-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Laurimed LLC, Redwood City, CA, United States |
| Recall initiated | 2014-04-07 |
| Classified | 2014-04-30 |
| Reported by FDA | 2014-05-07 |
| Terminated | 2014-05-14 |
| Distributed | AZ, CA, FL, ID, IL, NC, OR, PA, TX, VA, VT |
| Quantity | 58 |
| Lot numbers | LFG-111813-1, LFG020614-01 |
| Model numbers | FG-000016 |
| Expiration dates | 2014-06-20, 2014-09-20 |
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 for recall
The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1527-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.