Smiths Medical Portex 5ml Saline Recall: Risk of Infection from Leaking Containers
Smiths Medical recalls Portex 5ml Normal Saline (0.9%) Unit Dose containers due to leaking containers that could expose users to infectious agents. Affected units have model # UD9005 and lot number B515.
Lower-risk recall
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 Portex 5ml Normal Saline (0.9%) Unit D: containers that may leak, potentially exposing users to infections. This recall affects specific model and lot numbers. Read more at govinfonow.com/recall/73058-smiths-medical-portex-5ml-saline-recall-risk-of-infection-from.
Source Summary by GovInfoNow · govinfonow.com/recall/73058-smiths-medical-portex-5ml-saline-recall-risk-of-infection-from · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0721-2019
Cite this page
“Smiths Medical Portex 5ml Saline Recall: Risk of Infection from Leaking Containers.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73058-smiths-medical-portex-5ml-saline-recall-risk-of-infection-from. Based on FDA recall #Z-0721-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0721-2019%22&limit=1).
Why it’s dangerous
The containers may leak, which could expose users to infectious agents. This lack of sterility assurance means the saline solution might not be safe for medical use, increasing infection risk.
Who’s affected
Healthcare professionals and patients using the Portex 5ml Normal Saline (0.9%) Unit Dose containers with model # UD9005 and lot number B515 are affected. Those handling the product in medical settings are at higher risk.
How to tell if you have this one
Check for model number UD9005 and lot number B515 on the Portex 5ml Normal Saline (0.9%) Unit Dose containers. The product was sold with these specific identifiers.
- Brand
Smiths Medical- Category
Medical device
All 13 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Terminated- Distribution
Worldwide distribution: US (nationwide) to states of: 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, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0710-2019 | Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿; Model # 352 Lot Numbers: A214, A215, Z263, Z532, and Z555 | 70,860 |
| Z-0711-2019 | Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿; Model # 552 Lot Numbers: A054, A089, A090, and Z262 | 57,336 |
| Z-0712-2019 | Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿; Model # 1065 Lot Numbers: B209 and Z225 | 21,876 |
| Z-0713-2019 | Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿; Model # 1565 Lot Number: ¿Y371 | 9,828 |
| Z-0714-2019 | Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿; Model # 0352IMJ Lot Numbers: ¿A457, A597, B157, B236, Z589, Z655, Z656, and Z661 | 128,000 sold to Japan only |
| Z-0715-2019 | Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿; Model # 0552C Lot Number: ¿Z370 | 11,508 Canada only |
| Z-0716-2019 | Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿; Model # 0552IMJ Lot Numbers: ¿Z588 and Z597 | 16,104 Japan only |
| Z-0717-2019 | Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿; Model # HCS00300 Lot Number: ¿Y576 | 16,380 |
| Z-0718-2019 | Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿; Model # HCS00350 Lot Numbers: ¿A055, A056, A057, A058, A103, A176, A455, B530, B531, B532, B533, Z101, Z534, Z553, and Z554 | 235,560 |
| Z-0719-2019 | Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿; Model # R0059 Lot Number: ¿B360 | 102,000 |
| Z-0720-2019 | Portex Unit Dose 15 ml Normal Saline ¿; Model # R0159 Lot Numbers: ¿A661, B067, A526, A536, A569, and B201 | 357,552 |
| Z-0721-2019 | Portex 5ml Normal Saline (0.9%) Unit Dose¿¿¿¿ ¿; Model # UD9005 Lot Number: ¿B515 | 106,000 |
| Z-0722-2019 | Medline Prefilled 550 ml Sterile¿¿ ¿; Model # HCS00550 Lot Numbers: ¿A092, B205, B534, and Z205 | 54,924 |
What to do — step by step
Check Product Details
Verify the model number (UD9005) and lot number (B515) on the container.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 36 states.
FDA distribution: “Worldwide distribution: US (nationwide) to states of: 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, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: 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 6.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class I
- 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-0721-2019 (September 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0721-2019 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.