FDA Medical Device Recalls (openFDA)
MY01, INC.: MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
- Recall number
- Z-2384-2021
- Recalling firm
- MY01, INC.
- Product
- MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
- Status
- Terminated
- Initiated
- 2021-06-28
- Posted
- not on file
- Terminated
- 2022-07-25
- 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.
- Root cause
- Under Investigation by firm
- Action
- A Medical Device Advisory Notice dated 6/28/21 was sent to customers. Clinicians Responsibilities/ Actions required: 1. Review this notification for awareness of the contents 2. Identify and quarantine any unused affected products in your inventory for return to MY01 Inc. Contact Customer Success team by phone (+1 (855) 292-6901) or email (help@my01.io) to arrange for your replacements. 3. There are no specific patient monitoring instructions related to this voluntary product removal that are recommended beyond your existing follow up schedule. 4. Complete Attachment 1- Certificate of acknowledgement and email to help@my01.io by 07-Jul-2021. 5. Include a copy of Attachment 1- Certificate of acknowledgement with product to be returned. Please use the return shipping label (to be provided by MY01 Inc.), please return affected product to: Regulatory Affairs and Quality Management MY01 Inc. 400 Maisonneuve Boulevard West, Suite 700, Montreal, Quebec, Canada H3A 1L4 6. Retain a copy of this document and Attachment 1- Certificate of acknowledgement with your records. 7. If you have further questions or concerns after reviewing this notice, please call the customer service team at 1-855-292-6901. Alternatively, your questions may be emailed to: help@my01.io Under 21 CFR 803, manufacturers are also required to report any serious injuries where a product has contributed or may have contributed to the event. Please keep MY01 Inc. informed of any adverse events associated with this by emailing help@my01.io or call +1(855)-292-6901.
- Quantity
- 37 units
- Distribution
- US Nationwide distribution in the states of MD, OH, CA, NY.
- Lot, serial or model codes
- Lot Numbers: 9448532 9448838 9448979 9449000 9449237
- 510(k) numbers
- ["K210525"]
- PMA numbers
- not on file
- Product code
- LXC
- Firm FEI
- 3017398927
- Firm city
- Montreal
- Firm state
- not on file
- Firm country
- Canada
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28