ESAOTE S.P.A. Recalls Endocavity Ultrasonic Probes Due to Potential Liquid Leakage

Source: FDA · North Carolina, Texas

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ESAOTE S.P.A. has issued a voluntary recall for five Endocavity ultrasonic probes distributed in North Carolina and Texas due to a casing defect that may allow liquid leakage.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 2, 2026 and geographically references North Carolina, Texas. 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 — FDA Recalls — 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 recall 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.

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What Happened

ESAOTE S.P.A. has initiated a voluntary recall of specific Endocavity ultrasonic probes after identifying a potential structural weakness in the probe body. In a specific production batch, liquid may leak from the terminal part of the casing near the cable connection, potentially compromising the device's integrity.

Which Products Are Affected

The recall involves the Esaote Endocavity ultrasonic probe, Model E 3-12 (REF 120000038). A total of five units are affected by this recall, distributed within the states of North Carolina and Texas.

Identification Details:

  • UDI: 0805604453891
  • Serial Numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C
  • Recall Number: Z-1490-2026

What You Should Do

ESAOTE S.P.A. notified affected customers via letter starting in March 2025. Healthcare facilities and providers in possession of the specific serial numbers listed above should immediately follow the instructions provided in the firm's notification letter regarding the inspection, use, or return of the affected probes. For further information, users should contact the recalling firm, ESAOTE S.P.A., at their Sesto Fiorentino, Italy headquarters or through their authorized U.S. representatives.

Why This Matters

This recall is classified as Class II by the FDA, meaning the use of the defective product may cause temporary or medically reversible adverse health consequences. The leakage of liquid into or out of the probe casing could pose risks during medical procedures.

Source

Information provided by the FDA.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
ESAOTE S.P.A. has issued a voluntary recall for five Endocavity ultrasonic probes distributed in North Carolina and Texas due to a casing defect that may allow liquid leakage.
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 North Carolina, Texas. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.