The Recall Desk

Manufacturer

MY01, INC.

1 recall in our database name MY01, INC. as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2021-09-08

Of the 1 recalls from MY01, INC. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • HighFDA (Devices)·Z-2384-2021·2021-09-08

    MY01 Continuous Compartmental Pressure Monitor Recalled for Out-of-Specification Needle

    MY01, INC. is recalling the MY01 Continuous Compartmental Pressure Monitor (37 units) due to an incorrect needle with out-of-specification trocar geometry. The affected devices may require higher force to penetrate patient skin.

    Product
    MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001
    Category
    Medical Device
    Distribution
    Distributed nationwide