Salter Labs Recalls Oxygen Masks Due to Incorrect Labeling
Salter Labs is recalling 584 units of Model No. 8120-7 oxygen masks because the insert label incorrectly identifies the device as a non-rebreather instead of a partial rebreather.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (mis-labeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Salter Labs is voluntarily recalling 584 units of Oxygen Mask, Model No. 8120-7. The recall was initiated because the insert label incorrectly states the device is a non-rebreather, while the case label correctly identifies it as a partial rebreather. The product is a high-concentration partial rebreather with a 7-foot supply tube and elastic strap fixation intended for single-patient use.
The affected units were distributed nationwide in the United States and in Brazil, the United Kingdom, Indonesia, Morocco, Mexico, Norway, Venezuela, and South Africa. The recall covers specific lot numbers: 090213, 090913, 021714, 022414, 042814, 051914, and 052614.
Consumers and healthcare providers should stop using the affected masks and contact Salter Labs for further instructions. This recall is classified as Class II by the FDA, indicating a reasonable probability that the labeling error could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.
- Manufacturer
- Salter Labs
- Hazard
- Affected units
- 584
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 (7)
- Lot numbers: 090213
- 090913
- 021714
- 022414
- 042814
- 051914
- 052614
Distribution
Distributed nationwide across the United States.
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