Quick Facts at a Glance
- Recall Date
- September 5, 2025
- Hazard Level
- HIGH
- Brand
- Philips Ultrasound
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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
- Philips Ultrasound
- Product type
- TEE Ultrasound Transducer
- Model numbers
- Model No. 989605440701, 989605440702, 989605440772, 989803001561, UDI: (01)00884838067585(21)02ZTTT, (01)00884838067585(21)B0X7MD, (01)00884838067585(21)02VWNV, (01)00884838067585(21)02JQPG +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 5, 2025
Reported by FDA DEVICE
April 1, 2026
RecallRadar source check
April 8, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips Ultrasound, Inc or your healthcare provider for instructions. Notification method: Letter
About This Product
The Philips OMNI III TEE Ultrasound Transducer is used in intraprocedural imaging to guide trans esophageal echocardiography. Hospitals and clinics purchase these transducers to perform detailed cardiac assessments during procedures.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Facilities must halt use immediately to align with labeling guidance. There is cost and scheduling impact for device replacement and compliance paperwork.
Practical Guidance
How to identify if yours is affected
- Review the recall notice for the list of affected model numbers and UDIs.
- Check your inventory for any of the listed model numbers or UDIs.
- Isolate affected units from clinical use until guidance is received.
Where to find product info
Recall letter and enforcement notice from the FDA listing the model numbers and UDIs. Original recall URL: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number
What timeline to expect
Refunds or replacements are typically processed within 4-8 weeks after confirmation of eligibility.
If the manufacturer is unresponsive
- Escalate to hospital compliance or procurement.
- File a formal complaint with Philips recall management and document outreach attempts.
How to prevent similar issues
- Verify model numbers and UDIs against recall lists before deployment.
- Maintain an up-to-date inventory of recalled devices and isolate units immediately.
- Implement labeling policies that clearly define life-cycle and replacement guidance.
Documentation advice
Keep a copy of the recall notice, model numbers, UDI data, and all correspondence. Photograph affected units and record serials for records.
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Product Details
Quantity: 75 units. Distribution: US Nationwide distribution. Sold at: Unknown. Sold from: Unknown. Price: Unknown. Models include: Model No. 989605440701, 989605440702, 989605440772, 989803001561 and multiple UDI variants listed in the recall notice.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Product: Philips OMNI III TEE Ultrasound Transducer
- Distribution: US nationwide
- Remedy: Stop using immediately; follow manufacturer instructions
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