The Recall Desk
ModerateFDA (Devices)·Z-1834-2016·Announced 2016-06-08

MicroAire Pneumatic Impactor Recall for Missing Symbol Markings

MicroAire is recalling 20 Pneumatic Impactor units because they are missing required lock and unlock symbol markings.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling defect (missing symbols) with no reported injuries, fitting the criteria for moderate severity.

Plain-English summary

MicroAire Surgical Instruments, LLC is recalling 20 units of the Pneumatic Impactor, General Surgery, With Microaire Hose Connector. The recall was initiated because the suspect instruments were shipped to end users without the required lock and unlock symbol markings.

The affected units were distributed in the United States. The specific serial numbers involved are 1547, 1546, 1545, 1544, 1543, 1542, 1541, 1540, 1539, 1538, 1537, 1536, 1535, 1534, 1533, 1532 for model 2500-100, and 1464, 1463, 1462, 1461 for model 2500-200.

This recall is classified as Class II by the FDA. The source text does not report any illnesses or injuries associated with the missing markings.

The recalled product

Product
Pneumatic Impactor, General Surgery, With Microaire Hose Connector Professional Use, Medical Industry
Affected units
20

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (19)

  • 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

Distribution

Distribution scope not specified by the agency.

Same manufacturer · MicroAire Surgical Instruments, LLC

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