Smiths Medical Irrisept OR Bottle Recall: Leaking Containers Risk Infection
Smiths Medical recalls Irrisept OR 450ml bottles due to leaking containers that could expose users to infectious agents. Affected units include specific model and lot numbers.
Stop using this now
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Contact the company
What happened, in plain English
Smiths Medical is recalling Irrisept OR 45:00 ml bottles because they may leak, potentially exposing users to infections. This is serious because medical devices must be sterile to prevent health risks. Read more at govinfonow.com/recall/73073-smiths-medical-irrisept-or-bottle-recall-leaking-containers-risk-infection.
Source Summary by GovInfoNow · govinfonow.com/recall/73073-smiths-medical-irrisept-or-bottle-recall-leaking-containers-risk-infection · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0490-2019
Cite this page
“Smiths Medical Irrisept OR Bottle Recall: Leaking Containers Risk Infection.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73073-smiths-medical-irrisept-or-bottle-recall-leaking-containers-risk-infection. Based on FDA recall #Z-0490-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0490-2019%22&limit=1).
Why it’s dangerous
The bottles may leak, which can expose users to infectious agents. This happens because the containers lack proper sterility assurance, meaning they are not sealed correctly to prevent contamination.
Who’s affected
Healthcare professionals using the Irrisept OR product for medical procedures are most at risk. Patients receiving treatments through this device could be exposed to infections if the bottle leaks.
How to tell if you have this one
Check for the model number FB-A-400-107 and lot number 4J006 on the bottle. The product is sold as Irrisept OR, Finished Bottle Assembly 450 ml STEP 1.
- Brand
Smiths Medical- Category
Medical device
What to do — step by step
Stop Using Now
Immediately stop using the Irrisept OR 450 ml bottle if it has the model number FB-A-400-107 and lot number 4J006.
Where it went and when
Where it was distributed
Distributed in 36 states and Puerto Rico.
FDA distribution: “AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, and WI” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 7 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0490-2019 (September 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0490-2019 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.