Sterile Water for Irrigation Contamination Recall
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic has been recalled due to presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution. This recall primarily affects healthcare providers and hospitals. Individual consumers are unlikely to have this product.
By RecallRadar Editorial Team
Sourced from FDA. Last verified March 4, 2026.
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Check if you qualifyKey facts
- Date announced
- December 22, 2025
- Source agency
- FDA
This recall involves safety concerns. Take action promptly.
✨ Plain-English Summary
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic has been recalled due to presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution. This recall primarily affects healthcare providers and hospitals. Individual consumers are unlikely to have this product.
Is This Recall Still Active?
Status: Yes - Active
This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.
What's Being Recalled
Quoted source excerpt from the official notice.
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Quick Info
Key facts from the official notice, kept in the article flow for easy cross-checking.
- Brand
- Fda
- Category
- drug
- Source agency
- FDA
- Announced
- December 22, 2025
- Country
- US
- Status
- Active
Who's Affected
Specific models and identifiers listed in the source notice:
Model #1
Lot #: G171359, expiry: 05/31/2027
| # | Model |
|---|---|
| 1 | Lot #: G171359, expiry: 05/31/2027 |
Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.
What You Should Do
Follow the remedy path from the official notice using the exact model and serial details above.
- 1## Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-
- 2Agency: FDA | Category: drug Reason: Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution What to do:
- 3Stop using the product if your lot/model matches.
- 4Check the FDA notice for specifics.
Source & Verification
This page summarizes the official notice and keeps key facts easy to verify.
- Official source
- FDA
- Announced by source
- December 22, 2025
- Last reviewed by RecallRadar
- March 4, 2026
Frequently Asked Questions
Am I affected by this recall?
Check the affected models section on this page. The official notice currently lists Lot #: G171359, expiry: 05/31/2027.
What is the remedy for this recall?
## Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02. Agency: FDA | Category: drug Reason: Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution What to do: 1. Stop using the product if your lot/model matches. 2. Check the FDA notice for specifics. 3. Follow remedy instructions.
Where can I verify recall details?
Use the official source link in this page to confirm dates, eligibility, and next steps: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
Keep browsing with these internal hubs: FDA recall hub and Food & Drug recall hub.
Official Resources
Use these primary sources for final eligibility and claim instructions.
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On this page
Free checker
Check if you qualify
See whether your device may qualify for a free repair or replacement program before you spend money.
Check if you qualifyKey facts
- Date announced
- December 22, 2025
- Source agency
- FDA
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