Miramar Labs Recalls miraDry System for Labeling Update on Lubricant Use
Miramar Labs is recalling 277 miraDry Systems to update labeling that reminds users to use only approved lubricants in a thin layer to prevent burns and blisters.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential burns and blisters) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Miramar Labs, Inc. is recalling 277 units of the miraDry System, which consists of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. The device is intended for the treatment of primary axillary hyperhidrosis and the permanent removal of underarm hair. The recall affects all units with code MN-MD4000-MC and was distributed nationwide.
The recall is an update to the labeling for the miraDry Console. The updated labeling reminds users to only use approved lubricants in a thin layer to prevent potential burns and blisters. The source text does not report any specific illnesses or injuries associated with this recall.
Consumers who have this device should check their labeling and follow the updated instructions to ensure they are using only approved lubricants in a thin layer. The recall is classified as Class II by the FDA.
The recalled product
- Product
- miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories. General and Plastic Surgery: The miraDry System is intended for the treatment of primary axillary hyperhidrosis and was recently cleared for t
- Manufacturer
- Miramar Labs, Inc.
- Hazard
- Affected units
- 277
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)
- MN-MD4000-MC
- all units
Distribution
Distributed nationwide across the United States.
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