Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 9, 2020
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
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 …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Invacare Corporation recalled Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorder… - a moderate-severity action.
Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorder… was recalled by Invacare Corporation in December 9, 2020. Reason: Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valv…. Check the official notice for the remedy. Verify recall #Z-0514-2021 with the FDA Devices before acting.
The recall
Invacare Corporation issued this moderate-severity FDA Devices recall-Breakdown of the sound abatement washer, and metal on metal wear inside the Pressure Equalization (P.E.) valv….
- Moderate
- severity level
- 385K units
- affected scope
- Class II
- classification
- December 9, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0514-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0514-2021) was formally reported on December 9, 2020, with the manufacturer initiating the action on October 30, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Invacare Corporation is listed as the recalling firm, operating out of Elyria, OH. Federal records list the affected scope as 384,767 units, a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: 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 explosio… Distribution data in the federal record shows the product reached: Worldwide distribution. US Nationwide, Canada, Australia, China, Germany, Guam, New Zealand, and Northern Mariana Islands. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
384,767 units
Related Recalls
6
3 from same agency
Product description
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0514-2021 |
| Date reported | December 9, 2020 |
| Date initiated | October 30, 2020 |
| Recalling firm | Invacare Corporation |
| Firm location | Elyria, OH |
| Affected scope | 384,767 units |
| Distribution | Worldwide distribution. US Nationwide, Canada, Australia, China, Germany, Guam, New Zealand, and Northern Mariana Islands |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0514-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Invacare Corporation. Units affected: 384,767 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 9, 2020. Severity: Moderate. Recall number: Z-0514-2021.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution. US Nationwide, Canada, Australia, China, Germany, Guam, New Zealand, and Northern Mariana Islands.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0514-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 9, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.