MY01 Continuous Compartmental Pressure Monitor Recalled for Out-of-Specification Needle
MY01, INC. is recalling the MY01 Continuous Compartmental Pressure Monitor (37 units) due to an incorrect needle with out-of-specification trocar geometry. The affected devices may require higher force to penetrate patient skin.
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 3/5 (High).
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: This is a FDA Class II recall for a risk-of-harm medical device where no injuries or illnesses have been reported. The out-of-specification needle geometry poses a potential risk to patients, but the hazard remains theoretical without documented harm.
Plain-English summary
MY01, INC. is recalling the MY01 Continuous Compartmental Pressure Monitor (Reference Number MY01-0001). The recall affects 37 units distributed nationwide in Maryland, Ohio, California, and New York. The affected lot numbers are 9448532, 9448838, 9448979, 9449000, and 9449237.
The recalled devices contain an incorrect version of the needle in the introducer component. The needle trocar geometry does not meet specifications and may require users to apply slightly higher push force to penetrate patient skin than intended.
Healthcare facilities and providers using affected devices should contact MY01, INC. for guidance on device replacement or return. If you have used an affected device and have concerns about your health or the device's performance, please consult your healthcare provider.
The recalled product
- Product
- MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
- Manufacturer
- MY01, INC.
- Affected units
- 37
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 (1)
- Lot Numbers: 9448532 9448838 9448979 9449000 9449237
Distribution
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