The Recall Desk
ModerateFDA (Devices)·Z-1160-2023·Announced 2023-03-01

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.

What this means for you

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 abm
Manufacturer
S & MOHR AMERICA, S.A. DE C.V.
Hazard
  • label-error
  • expiration-date-mislabeling

Distribution

Distributed nationwide across the United States.