Smiths Medical Sterile Eyewash Recall: Infection Risk
Smiths Medical recalls 4 oz sterile eyewash bottles due to leaking containers that lack sterility assurance, posing an infection risk.
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
Medex Cardio-Pulmonary Inc., doing business as Smiths Medical Company, is recalling Sterile Eyewash (sterile isotonic phosphate buffered saline solution) because the containers may leak. This defect means the product lacks sterility assurance and could expose users to infectious agents. The recall affects 22,080 bottles distributed in Iowa and Wisconsin. Read more at govinfonow.com/recall/41261-smiths-medical-sterile-eyewash-recall-infection-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41261-smiths-medical-sterile-eyewash-recall-infection-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-0158-2018
Cite this page
“Smiths Medical Sterile Eyewash Recall: Infection Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41261-smiths-medical-sterile-eyewash-recall-infection-risk. Based on FDA recall #D-0158-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0158-2018%22&limit=1).
Why it’s dangerous
The primary hazard is that the containers are leaking, which compromises the sterility of the solution inside. Because the product lacks sterility assurance, using it could lead to exposure to infectious agents rather than providing safe cleansing.
Who’s affected
Individuals or facilities in Iowa and Wisconsin who purchased the recalled Sterile Eyewash bottles. Users are at risk of exposure to infectious agents if they use the leaking containers.
How to tell if you have this one
Check if you have Sterile Eyewash (sterile isotonic phosphate buffered saline solution) in 4 oz bottles, with 24 units per box. Look for Model Number 32-005583 and Lot A225. The product was manufactured by Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company.
- Brand
Smiths Medical- Category
Drug
All 4 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 II- Status
Terminated- Distribution
IA, WI
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0157-2018 | Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 1 oz. 144 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061 Model Number: 32-005582.; Lot: Z516 | 29,232 1 oz bottle |
| D-0158-2018 | Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 4 oz. 24 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005583; Lot: A225 | 22,080 4 oz bottles |
| D-0159-2018 | Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005585; Lot: A259, A260, EXP 05-26-2018; A301, 06-23-2018; B117, B118, EXP 03-02-2019; C005, EXP 01-09-2020; C219, EXP 05-24-2020; Z521, EXP 10-06-2017 | 130,740 16 oz bottles |
| D-0160-2018 | Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 32 oz. 12 units per box. Manufactured by Medex Cardio-Pulmonary Inc. d.b.a. Smiths Medical Company, 300 Corporate Woods Pkwy, Vernon Hills. Illinois, USA 60061. Model Number: 32-005587; Lot: A257, EXP 05-20-2018; A258, EXP 05-19-2018; B017, EXP 01-12-2019; B116, B119, EXP 05-03-2019; B120, EXP 05-04-2019; B131, EXP 05-05-2019; Z535, EXP 10-13-2017; Z638, EXP 12-19-2017. | 96,828 32 oz bottles |
What to do — step by step
Stop using the product
Do not use the recalled Sterile Eyewash bottles due to the risk of infection from leaking containers.
Check your inventory
Verify if you have Model Number 32-005583 or Lot A225 distributed in Iowa or Wisconsin.
Where it went and when
Where it was distributed
Distributed in Iowa and Wisconsin.
FDA distribution: “IA, WI” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Iowa, Wisconsin.
Recall timeline
FDA terminated this recall 15 months 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 #D-0158-2018 (September 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0158-2018 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.