CLASS II Device recall · Reported 8 Jun 2016 · FDA Enforcement Report
Pneumatic Impactor, General Surgery recalled
MicroAire Surgical Instruments is recalling Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use. The recall was initiated on 11 Mar 2016 and the FDA has classified it as Class II.
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-1834-2016
- FDA event ID
- 73661
- Recalling firm
- MicroAire Surgical Instruments, Charlottesville, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Mar 2016
- FDA classified
- 27 May 2016
- Reported
- 8 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 11 Mar 2016 | Recall initiated by company | |
| 27 May 2016 | Classified by FDA | +77 days |
| 8 Jun 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
MicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumatic Impactor) were shipped to end users and were missing the lock and unlock symbol markings on them.
Product as listed by the FDA
Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry
Where it was distributed
United States
Questions about this recall
Why was it recalled?
MicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumatic Impactor) were shipped to end users and were missing the lock and unlock symbol markings on them.
Which lots are affected?
2500-100 Ser#s 1547,1546,1545,1544, 1543,1542, 1541,1540,1539,1538,1537,1536,1535,1534,1533,1532 2500-200 Ser#s 1464,1463,1462,1461
Where was it sold?
United States
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 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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