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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86604

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

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Event summary

Timeline bucket
October 30, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Invacare Corporation

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

Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen Model Numbers: IRC5PO2V (US), IRC5PO2VC (Canada), All World: IRC5PO2VAW, IRC5PO2VAWL2, IRC5PO2VAWL3, IRC5PO2VAWL4, IRC5PO2VAWL5

Z-0514-2021
Recall number
Z-0514-2021
Initiated
October 30, 2020
Classification
Class II
Status
Terminated
Recalling firm
Invacare Corporation
Quantity
384,767 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valve assembly in the concentrator may lead to failure that can result in self-extinguishing fires or cap explosions.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valve assembly in the concentrator may lead to failure that can result in self-extinguishing fires or cap explosions.

Code information

Model numbers: IRC5PO2V from Serial # 14HF039890 to 18JF007415; IRC5PO2VC from Serial # 14IF004028 to 18JF028633; IRC5PO2VAW from serial #17HF030338-18IF018522; IRC5PO2VAWL2 from serial # 18BF007341-18IF024451; IRC5PO2VAWL3 from serial # 17JF002563-19AF008559; IRC5PO2VAWL5 from serial # 18EF003466-18EF003544. DI Number: 00841447100249

Distribution pattern

Worldwide distribution. US Nationwide, Canada, Australia, China, Germany, Guam, New Zealand, and Northern Mariana Islands