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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91112

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

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Event summary

Timeline bucket
November 18, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
DeVilbiss Healthcare LLC

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

DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q

Z-0724-2023
Recall number
Z-0724-2023
Initiated
November 18, 2022
Classification
Class II
Status
Ongoing
Recalling firm
DeVilbiss Healthcare LLC
Quantity
1004315 (US); 414559 (OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling False and Misleading

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components.

Code information

Model 525DS UDI-DI 00885304000846 All Lots Model 525DS-Q UDI-DI 00885304009689 All Lots

Distribution pattern

US Nationwide. Foreign distribution pending.