Exact FDA event identifier

Event 98563

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

Open FDA event record

Event summary

Timeline bucket: February 04, 2026
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: 3B Medical, 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

React Health PHOENIX 5L Oxygen Concentrator

Z-1815-2026

Recall number: Z-1815-2026
Initiated: February 04, 2026
Classification: Class II
Status: Ongoing
Recalling firm: 3B Medical, Inc.
Quantity: 2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Devices which did not meet internal quality specifications were inadvertently distributed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Storage

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Devices which did not meet internal quality specifications were inadvertently distributed.

Code information

UDI 06934726614439-250623-MZJ5S713971, Serial Number MZJ5S713971; UDI 06934726614439-250623-MZJ5S714009, Serial Number MZJ5S714009

Distribution pattern

US Nationwide distribution in the state of NY.