FDA Device recall Z-2384-2021
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
- FDA Device
- Class II
- terminated
- Published 2021-09-08
On 2021-09-08 the FDA classified a Class II recall of MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001 by My01, citing 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 spec….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2384-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-28 |
| Published | 2021-09-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | My01 |
| Distribution | US |
Product
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
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.
Identifiers
| code_info | Lot Numbers: 9448532 9448838 9448979 9449000 9449237 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2384-2021%22
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