Lower riskDrug recall · FDA · Published December 22, 2025
Baxter Sterile Water for Irrigation Recall: Plastic Particles in Solution
Baxter Healthcare recalls 250mL single-dose sterile water bottles due to plastic particles floating into the solution. This may cause infection or injury during medical use.
“Baxter Sterile Water for Irrigation Recall: Plastic Particles in Solution.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31602-baxter-sterile-water-for-irrigation-recall-plastic-particles-in-solution. Based on FDA recall #D-0296-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0296-2026%22&limit=1).
The FDA announced on Dec. 22, 2025, that Baxter Healthcare Corporation is voluntarily recalling Sterile Water for Irrigation due to the presence of plastic particulate matter. The agency issued recall number D-0296-2026 for the affected single-dose bottles distributed nationwide.
How to tell if you have it
Brand: Baxter Healthcare
Product: Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only
Manufacturer location: Deerfield, IL 60015
NDC: 0338-0004-02
Lot #: G171359
Expiry date: 05/31/2027
Units affected: 125,496 bottles
The hazard
The recall is due to the presence of particulate matter, specifically plastic particles from the bottle rim observed floating into the solution. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Baxter Healthcare Corporation has 187 other recalls on record since Sept. 2, 2015. Other recent recalls of similar products include Baxter PRO+ 40" MRS SURFACE Mattress Recall (Aug. 18, 2026), Baxter 0.9% Sodium Chloride Injection Recall (Aug. 17, 2026), and Baxter Dextrose 2000mL Bags Recall (Aug. 17, 2026). Other recent recalls of similar products include B Braun 3000mL Sterile Saline Bags Recall (April 2, 2026), B Braun Lactated Ringer's Irrigation Bags Recall (April 2, 2026), and B. Braun Medical Sterile Water for Injection Bags (April 2, 2026).
How to tell if you have this one
This product is a 250 mL single-dose plastic bottle labeled 'Sterile Water for Irrigation, Rx Only'. It was manufactured by Baxter Healthcare Corporation in Deerfield, IL with lot number G171359 and expires May 31, 2027.
Brand
Baxter Healthcare
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the lot number G171359 and expiration date of May 31, 2027 on the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 44 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0296-2026 (December 22, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0296-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.