Facility

MY01, INC.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3017398927
Establishment type	Manufacture Medical Device
Location	400 De Maisonneuve Boulevard West Montreal Quebec, CA H3A 1L4
Registration status	Active · expires 2026
Parent company	MY01, Inc. (owner-operator 10061277)
Brand names	MY01 Continuous Compartmental Pressure Monitor

Activity by year

Recalls (1)

Devices registered here (1)

Monitor, Pressure, Intracompartmental
Product code LXC (opens in a new tab) · Unclassified · Unknown

Recalls & enforcement

Class IITerminated2021-06-28
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.

All facilities operated by MY01, Inc.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “MY01, INC. (FEI 3017398927) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3017398927-my01-inc/

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