CLASS III Device recall · Reported 7 May 2014 · FDA Enforcement Report
PolypVac Microdebrider recalled by Laurimed
Laurimed is recalling PolypVac Microdebrider, distributed in 11 states. The recall was initiated on 7 Apr 2014 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1527-2014
- FDA event ID
- 67950
- Recalling firm
- Laurimed, Redwood City, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 7 Apr 2014
- FDA classified
- 30 Apr 2014
- Reported
- 7 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 7 Apr 2014 | Recall initiated by company | |
| 30 Apr 2014 | Classified by FDA | +23 days |
| 7 May 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Distributed in the states of CA, VT, NC, DO, TX, FL, PA, OR, AZ, IL, ID, and VA.
ArizonaCaliforniaFloridaIdahoIllinoisNorth CarolinaOregonPennsylvaniaTexasVirginiaVermont
Questions about this recall
Is PolypVac Microdebrider recalled?
Yes. Laurimed recalled PolypVac Microdebrider on 7 Apr 2014. The recall is Class III and its status is Terminated. Recall number Z-1527-2014.
Why was it recalled?
The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.
Which lots are affected?
Lot Number: LFG-111813-1; Expiry date: June 2014; LFG020614-01, Expiry date: September 2014.
Where was it sold?
Distributed in the states of CA, VT, NC, DO, TX, FL, PA, OR, AZ, IL, ID, and VA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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