# FDA recall Z-2384-2021

> **MY01, INC.** · Class II · device recall initiated 2021-06-28.

## Product

MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001

## Reason for recall

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.

## Distribution

US Nationwide distribution in the states of MD, OH, CA, NY.

## Key facts

- **Recall number:** Z-2384-2021
- **Recalling firm:** MY01, INC.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-06-28
- **Report date:** 2021-09-08
- **Termination date:** 2022-07-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Montreal, N/A, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2384-2021

## Citation

> AI Analytics. FDA recall Z-2384-2021. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-2384-2021. Source: US FDA. Licensed CC0.

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