MY01 Continuous Compartmental Pressure Monitor — Class II medical device recall Z-2384-2021
Terminated recall by MY01, INC., reported 2021-09-08, distributed nationwide. There is an incorrect version of the needle in the introducer part of devices. The affected Lots were manufact
| Recall number | Z-2384-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MY01, INC., Montreal, N/A, Canada |
| Recall initiated | 2021-06-28 |
| Classified | 2021-08-27 |
| Reported by FDA | 2021-09-08 |
| Terminated | 2022-07-25 |
| Distributed | Nationwide (US) |
| Quantity | 37 units |
| Reason classes | specification failure |
| Lot numbers | 9448532, 9448838, 9448979, 9449000, 9449237 |
Product
MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2384-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.