Device recall: Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains…

Class II FDA enforcement event 69441. Recall start date: 23 Sep 2014. Status in the FDA record: Terminated. Termination date: 18 Jun 2015.

Reason for recall, in the words of FDA

It was determined that a defective sieve bed subassembly enabled zeolite sieve dust from the sieve beds to migrate into the valves of the manifold assembly and muffler causing a reduction in oxygen concentration.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Invacare Corporation started this device recall on 23 Sep 2014. The firm address in the FDA record is in Elyria, OH. FDA put the recall in Class II. FDA event 69441 has 1 product record. The first FDA enforcement report date is 17 Dec 2014. The record gives the status Terminated, with the termination date 18 Jun 2015.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide Distribution -- FL, NJ, GA, RI, PA, MI, CA, MA, IN, WA, CT, VA, NC, MO, AZ, CO, MS, MI, WI, TN, NH, IL, LA, OK, HI, KY, NE, SC, TX, IA, IN, and MS.

Recalling firm

Invacare Corporation, Elyria, OH.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 69441: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0577-2015	Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished device. Intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from…	5,963	Class II	Terminated	17 Dec 2014

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2014: 1,176
Share of these events in Class II: 91%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 26

Other events of the firm

Other FDA enforcement events of Invacare Corporation
Initiated	Product (first record)	Type	Class	Records
22 Jan 2024	Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4)	Device	Class II	1
15 Jun 2023	DOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. Model Number(s): 1654	Device	Class II	1
10 Jun 2022	Invacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)	Device	Class III	1
30 Mar 2022	Invacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2V	Device	Class II	1
12 Nov 2021	Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Mod	Device	Class II	3
30 Oct 2020	Invacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiring supplemental oxygen	Device	Class II	1
16 Nov 2018	Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a Non-AC-Powered patient	Device	Class II	1
25 Apr 2017	Assist Bed Rail - 6632	Device	Class II	1
2 Dec 2016	Bariatric Bed - BAR600IVC	Device	Class II	4
21 Jun 2016	lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare Precise Rx Pediatric	Device	Class II	2

Invacare Corporation: all 26 events

Official channels

FDA enforcement report Z-0577-2015The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 69441. https://recallregister.com/fda/ii/69441/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide Distribution -- FL, NJ, GA, RI, PA, MI, CA, MA, IN, WA, CT, VA, NC, MO, AZ, CO, MS, MI, WI, TN, NH, IL, LA, OK, HI, KY, NE, SC, TX, IA, IN, and MS.
What quantity of product is in FDA event 69441?: The FDA record gives this quantity: 5,963
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2014 have the same class?: 91% of the 1,176 device events that started in 2014 are in Class II.