Sterile Eyewash (Smiths Medical) – Sterility Risk (2017)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Lot Codes / Batch Numbers
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
Products Sold
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
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company is recalling Sterile Eyewash (sterile isotonic phosphate buffered saline solution), 16 oz. 12 units per box. Manu due to Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IA, WI
Page updated: Jan 7, 2026