MY01, INC.: Medical Device Recall in 2021 - (Recall #: Z-2384-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001

Product Classification:

Class II

Date Initiated: June 28, 2021

Date Posted: September 8, 2021

Recall Number: Z-2384-2021

Event ID: 88396

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.

Status: Terminated

Product Quantity: 37 units

Code Information:

Lot Numbers: 9448532 9448838 9448979 9449000 9449237

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated