Quick Facts at a Glance
- Recall Date
- March 14, 2025
- Hazard Level
- HIGH
- Brand
- ESAOTE
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- ESAOTE
- Product type
- Endocavity Ultrasonic Probe
- Model numbers
- E 3-12, 120000038, UDI 0805604453891, 241700533C, 241700529C, 241700607C, 241700536C, 241700613C
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 14, 2025
Reported by FDA DEVICE
March 11, 2026
RecallRadar source check
March 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ESAOTE S.P.A. or your healthcare provider for instructions. Notification method: Letter
About This Product
The ESAOTE Endocavity Ultrasonic Probe E 3-12 is used in ultrasound imaging with endocavity applications. Healthcare facilities rely on these probes for diagnostic procedures.
Why This Is Dangerous
A weakness in the probe body can allow liquid to leak from the terminal area near the cable. Liquid exposure can pose electrical and chemical risks during use.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Only 5 units were involved with US distribution in NC and TX. The risk is contingent on usage and exposure to the leaked liquid.
Practical Guidance
How to identify if yours is affected
- Locate the device label for Model E 3-12 and REF 120000038.
- Check UDI 0805604453891 on the device packaging or label.
- If a match is found, stop using the device immediately.
Where to find product info
Recall notices are available through ESAOTE and the FDA enforcement page linked in the recall notice.
What timeline to expect
Typical recall remediation timelines vary; hospitals usually process replacements within weeks. The data does not specify exact timing for refunds or替
If the manufacturer is unresponsive
- Escalate to hospital risk management or biomedical engineering.
- File a formal complaint with ESAOTE and consult your regulatory body if needed.
How to prevent similar issues
- Verify model, REF, UDI, and serial numbers before using ultrasound probes.
- Buy from authorized distributors.
- Schedule routine device recalls checks with biomedical engineering staff.
Documentation advice
Keep recall notice, serial numbers, UDI, and all correspondence. Document the steps taken to remove affected devices from service.
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Product Details
Model: E 3-12 Reference: REF 120000038 UDI: 0805604453891 Serial numbers: 241700533C, 241700529C, 241700607C, 241700536C, 241700613C Where sold: United States, nationwide with distribution to NC and TX When sold: Recall dated 2025-03-14 Estimated quantity: 5 units Price: Unknown
Key Facts
- US distribution in NC and TX
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Safety Guide
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