Device recall: 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D…
Class II FDA enforcement event 90950. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway)
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
DeVilbiss Healthcare LLC started this device recall on 19 Sep 2022. The firm address in the FDA record is in Somerset, PA. FDA put the recall in Class II. FDA event 90950 has 1 product record. The first FDA enforcement report date is 23 Nov 2022. The record gives the status Ongoing.
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 . openFDA export of .
Distribution
In the words of FDA.
US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada.
Recalling firm
DeVilbiss Healthcare LLC, Somerset, PA.
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.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0229-2023 | 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB | 48 units | Class II | Ongoing | 23 Nov 2022 |
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 2022
- 839
- Share of these events in Class II
- 88%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 6
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 9 Mar 2023 | DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR | Device | Class II | 1 |
| 18 Nov 2022 | DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q | Device | Class II | 1 |
| 23 May 2016 | DeVilbiss Model 7305P-D Powered Suction Unit | Device | Class II | 1 |
| 13 May 2014 | DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of pos | Device | Class III | 1 |
| 7 Mar 2013 | DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML D | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0229-2023The 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 90950. https://recallregister.com/fda/ii/90950/. Source: openFDA enforcement reports. Data through .
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:
US Distribution in states of: CA, FL, OH, MI, MN, NY, PA, and TX; and (Foreign) country of: Canada.
- What quantity of product is in FDA event 90950?
- The FDA record gives this quantity:
48 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2022 have the same class?
- 88% of the 839 device events that started in 2022 are in Class II.