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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88396

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 28, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
MY01, INC.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

MY01 Continuous Compartmental Pressure Monitor, Reference Number MY01-0001

Z-2384-2021
Recall number
Z-2384-2021
Initiated
June 28, 2021
Classification
Class II
Status
Terminated
Recalling firm
MY01, INC.
Quantity
37 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Lot Numbers: 9448532 9448838 9448979 9449000 9449237

Distribution pattern

US Nationwide distribution in the states of MD, OH, CA, NY.