> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Class 1 Recall of Smiths Medical Saline/Water
- URL: https://www.fdaweb.com/class-1-recall-of-smiths-medical-saline-water/
- Published: 2019-02-04T12:00:00.000Z
- Updated: 2026-09-15T01:00:05.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143287

FDA has classified as Class 1 a Smiths Medical recall of its sterile saline and sterile water products for inhalation due to the potential exposure to infectious agents (*bacillus infantis* and *staphylococcus epidermidis*) from damage to the containers used to package the finished products. Product use in patients could result in infection and may require treatment with antibiotics, a [recall notice](https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm630614.htm?ref=fdaweb.com) says. Serious or untreated infections could result in patient death, it says.