MicroAire Recalls Endotine Transbleph 3.5 Due to Minor Mislabeling
MicroAire is recalling 29 units of Endotine Transbleph 3.5 because the side label lists an incorrect part number.
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 for minor labeling errors, which corresponds to a score of 2 (Moderate) per the rubric.
Plain-English summary
MicroAire Surgical Instruments, LLC has initiated a limited recall of 29 units of the Endotine Transbleph 3.5 (CFD-080-0167), Lot # 285373. The recall is due to minor mislabeling where the front label is correct, but the side label lists an incorrect part number (CFD-080-0177).
The affected product was distributed in the United States and Sweden. This is a Class II recall classified by the U.S. Food and Drug Administration.
Consumers and healthcare providers should stop using the affected units and contact MicroAire Surgical Instruments for instructions on return or replacement.
The recalled product
- Product
- Endotine Transbleph 3.5 (CFD-080-0167)
- Manufacturer
- MicroAire Surgical Instruments, LLC
- Hazard
- Affected units
- 29
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 (2)
- Endotine Transbleph 3.5 (CFD-080-0167)
- Lot # 285373
Distribution
Distribution scope not specified by the agency.
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