ConvaTec Recalls Elongated Adult Non-Rebreather Oxygen Masks
ConvaTec is voluntarily recalling specific lots of elongated adult non-rebreather oxygen masks. The recall was initiated in 2017 and is now terminated.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls without explicit reports of hospitalization or significant injury are categorized as High severity.
Plain-English summary
ConvaTec, Inc. is voluntarily recalling specific lots of Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Product Code 3106-E. The recall was initiated on May 10, 2017, and was terminated on August 27, 2021. The FDA classified this recall as Class II.
The affected product was distributed to various locations in the United States, including California, Connecticut, Florida, Georgia, Illinois, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, Virginia, and Puerto Rico. The product was also distributed internationally to Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam.
The source text does not specify the reason for the recall or the specific hazard associated with the product. Consumers should check their product lot numbers against the list provided in the official recall notice to determine if they are affected.
The recalled product
- Product
- Oxygen Masks, Elongated (Under Chin) Adult High Conc., Non-Rebreather, 7ft O2 Tubing, Check Valve, One Side Valve, FITS-All Conn., Product Code 3106-E
- Manufacturer
- ConvaTec, Inc
- Category
- Medical Device — Oxygen Masks
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- Lot Number 100272
- 100465
- 101132
- 101616
- 101994
- 102398
- 102788
- 102935
- 103192
- 103384
- 103445
- 103851
- 103908
- 104078
- 104902
- 104947
- 105189
- 105441
- 105935
Distribution
Part of a larger recall action
This product is one of 18 recalled by ConvaTec, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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