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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95818

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

Open FDA event record

Event summary

Timeline bucket
December 09, 2024
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD

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

JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L

Z-0795-2025
Recall number
Z-0795-2025
Initiated
December 09, 2024
Classification
Class I
Status
Ongoing
Quantity
6,520

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Oxygen concentrator may melt or catch on fire during use.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Oxygen concentrator may melt or catch on fire during use.

Code information

UDI-DI: 00092237623152. Serial Number Ranges: JA2311000001-JA2311000740, JA2311000741-JA2311001480, JA2311001481-JA2311002220, JA2311002221-JA2311002960, JA2311002961-JA2311003700, JA2312000001-JA2312000740, JA2312000741-JA2312001480, JA2312001481-JA2312002080, JA2401000001-JA2401000740.

Distribution pattern

US: OH