Respiratory care breathing circuits recalled for incorrect expiration date labeling
S & MOHR AMERICA recalled approximately 1,320 abm Respiratory Care Standard Breathing Circuits due to incorrect expiration dates printed on product labels. The manufacturing date was printed where the expiration date should appear.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: FDA Class III recall involving a labeling error (manufacturing date printed as expiration date). No illnesses or injuries reported. Per the severity rubric, Class III recalls are typically scored 1–2; this minor labeling error is scored as Moderate.
Plain-English summary
This recall involves abm Respiratory Care Standard Breathing Circuits with Face Mask in four sizes (Toddler, Child/Adult Small, Adult Large, and Adult Medium). Approximately 1,320 masks are affected. The manufacturer, S & MOHR AMERICA, S.A. DE C.V., initiated this recall due to incorrect expiration dates printed on the product labels.
The issue stems from a labeling error in which the manufacturing date was printed where the expiration date should appear. The correct expiration date for affected products is July 22, 2027. Affected lot numbers include SM6002.2207.12 (Toddler), SM6003.2507.12 (Child/Adult Small), SM6001.2207.12 (Adult Large), and SM6004.2607.12 (Adult Medium). The affected products were distributed nationwide, with distribution reported in Minnesota.
Healthcare facilities and consumers who have received these products should verify they have the correct expiration date information and contact the manufacturer with questions regarding the proper expiration dates for their products.
The recalled product
- Product
- abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Breathing Circuit with Face Mask - Child/Adult Small REF BC21088 abm Respiratory Care Standart Breathing Circuit with Face Mask - Adult Large REF BC21273…
- Manufacturer
- S & MOHR AMERICA, S.A. DE C.V.
- Affected units
- 1,320
Distribution
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