Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Irrisept OR Recalled by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company Due to Lack of sterility assurance: leaking containers which could...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company directly.
Affected Products
Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
Quantity: 10,440
Why Was This Recalled?
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Where Was This Sold?
This product was distributed to 36 states: AZ, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NY, NC, OH, OR, PA, SC, TN, TX, UT, VT, VA, WA, WI
About Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company has 18 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report