Class II — MY01, INC.
| Recalling firm | MY01, Inc. |
|---|---|
| Registered facility | MY01, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is an incorrect version of the needle in the introducer part of devices. The affected Lots were manufactured using needles with a needle trocar geometry which is out of specification and may require a slightly higher push force from the user to penetrate the patient skin. |
| Product | MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001 |
| Quantity | 37 units |
| Distribution | US Nationwide distribution in the states of MD, OH, CA, NY. |
| Initiated | 2021-06-28 |
| Classified | 2021-08-27 |
| Terminated | 2022-07-25 |
| Recall number | Z-2384-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — MY01, INC. (Z-2384-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88396/
Alerts for MY01, Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.