Sterile Water Irrigant
FDA Recall NDC 0338-0004
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Sterile Water (NDC 0338-0004). A significant event, classified as Class II, was initiated on Dec 22, 2025 by Baxter Healthcare Corporation. The reported reason for this action was: "Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Dec 22, 2025
Feb 04, 2026
125,496 bottles
Recall Profile & Regulatory Data
Event ID
98178
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Batch or Lot Expiration Information
Lot# : G171359, expiry: 05/31/2027
Affected Packages Involved in this Recall
0338-0003-44Product
0338-0003-46Product
0338-0003-47Product
0338-0004-02Product
0338-0004-03Product
0338-0004-04Product
0338-0004-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
