Lower risk Medical device recall · FDA · Published June 28, 2021

MY01 Pressure Monitor Recall: Incorrect Needle May Require Higher Push Force

MY01 recalls specific model pressure monitors with a faulty needle that may need more force to penetrate skin. Affected units include lot numbers 9448532, 9448838, 9448979, 9449000, 9449237.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2384-2021Medical device MY01 ›

Lower-risk 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.

Take action

Contact the company

Recalling firmMY01, INC.400 De Maisonneuve Blvd W Suite 700 · Montreal, Canada

✎ GovInfoNow plain-language explainer

MY01 recalls certain continuous compartmental pressure monitors due to a faulty needle that may require more force to penetrate skin. This could lead to discomfort or injury during use if the needle is too stiff. Read more at govinfonow.com/recall/62299-my01-pressure-monitor-recall-incorrect-needle-may-require-higher-push.

Source Summary by GovInfoNow · govinfonow.com/recall/62299-my01-pressure-monitor-recall-incorrect-needle-may-require-higher-push · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2384-2021

Cite this page

“MY01 Pressure Monitor Recall: Incorrect Needle May Require Higher Push Force.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62299-my01-pressure-monitor-recall-incorrect-needle-may-require-higher-push. Based on FDA recall #Z-2384-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2384-2021%22&limit=1).

MY01, INC. recalled its MY01 Continuous Compartmental Pressure Monitor (Reference Number MY01-0001) due to an incorrect needle version in the introducer that may require higher push force, according to the FDA on June 28, 2021.

How to tell if you have it

Brand: MY01
Product: MY01 Continuous Compartmental Pressure Monitor
Reference Number: MY01-0001
Lot Numbers: 9448532, 9448838, 9448979, 9449000, 9449237

The hazard

The affected devices contain needles with a trocar geometry that is out of specification. This defect may require the user to apply slightly higher push force to penetrate patient skin.

Context

GovInfoNow's records show MY01, INC. has had other recalls in the past. Other recent recalls of similar products include DeRoyal Myocardial Probe Recall (2026-08-20), ConMed AirSeal 12mm Access Port Recall (2026-05-14), and B. Braun 21GA Winged Infusion Needle Recall (2026-02-02).

How to tell if you have this one

Check the lot number on your device. Affected units include 9448532, 9448838, 9448979, 9449000, and 9449237. The product is a continuous compartmental pressure monitor from MY01, Inc.

Brand
MY01
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Lot Number
Identify the lot number on your device to see if it matches the affected numbers: 9448532, 9448838, 9448979, 9449000, 9449237.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 4 states.

FDA distribution: “US Nationwide distribution in the states of MD, OH, CA, NY.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Maryland, New York, Ohio.

Recall timeline

FDA terminated this recall 13 months after the firm started it.

Jun 28, 2021Firm started the recall
Aug 27, 2021FDA classified it Class II
Sep 8, 2021Published in FDA’s Enforcement Report
Jul 25, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/62299-my01-pressure-monitor-recall-incorrect-needle-may-require-higher-push">MY01 Pressure Monitor Recall: Incorrect Needle May Require Higher Push Force (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2384-2021 (June 28, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2384-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.