Sterile Water Irrigant Facing Ongoing Shortage: Manufacturer Availability and Recovery Updates

Source: FDA · United States

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The FDA has reported a current shortage of Sterile Water Irrigant, with supply levels varying significantly across major manufacturers including Baxter and Otsuka ICU Medical.

What this FDA drug-shortage notice tells you, and what most readers miss

This notice was issued by FDA on February 11, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — Drug Shortages — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA drug-shortage notice is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (drug-shortage, fda, medication, Sterile Water Irrigant) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.

What's in Shortage

Sterile Water Irrigant (Brand Name: STERILE WATER) is currently listed in a shortage status by the FDA. This medication is an irrigant used across several therapeutic categories, including Gastroenterology, Pediatrics, and other medical applications.

Which Manufacturers Are Affected

Availability varies by manufacturer and specific product presentation:

  • B. Braun Medical Inc.: Currently has product Available (NDC 0264-2101-10 and 0264-2101-00). For inquiries, contact 800-227-2862.
  • Otsuka ICU Medical LLC: Reports Limited Availability and Unavailable status for various presentations. Products are distributed by ICU Medical and some are currently allocated to contracted customers only. Recovery dates are currently To Be Determined (TBD). Contact: 1-866-829-9025 or ProductAvailability@icumed.com.
  • Baxter Healthcare: Reports both Limited Availability and Unavailable status for 100 mL presentations. The estimated recovery date for these products is April 2026. Contact: 888-229-0001.

Why There's a Shortage

The FDA has categorized the reason for this shortage as "Other." No further specific details regarding the cause were provided in the source data.

What Patients Should Do

If you or a family member rely on Sterile Water Irrigant, please consider the following steps:

  • Consult Your Healthcare Provider: Speak with your doctor or specialist regarding your treatment plan and any necessary adjustments.
  • Speak with Your Pharmacist: Pharmacists can provide the most up-to-date information on local stock and potential alternatives.
  • Contact Manufacturers: If you have specific questions about product availability, you may use the contact information provided above.

Disclaimer: This article is for informational purposes only. Patients should always consult with their healthcare provider or pharmacist for medical advice and treatment options.

Source

Information provided by the FDA Drug Shortage Database. Initial Posting Date: 04/28/2023
Last Updated: 02/06/2026

Original source: FDA Official Notice ↗

All Drug Shortages →

Frequently Asked Questions

Common questions about this FDA drug-shortage notice.

What is this FDA drug-shortage notice about?
The FDA has reported a current shortage of Sterile Water Irrigant, with supply levels varying significantly across major manufacturers including Baxter and Otsuka ICU Medical.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more Drug Shortages updates?
Browse the full Drug Shortages feed on Areazine at areazine.com/drug-shortages/ for the latest updates from FDA and other agencies.