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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Manufacturer
- MicroAire Surgical Instruments, LLC
- Hazard
- 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.
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