ESAOTE S.P.A. Recalls Endocavity Ultrasonic Probes Due to Potential Liquid Leakage
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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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevice.
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 ↗
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