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
- Ultrasound Transducer
- Model numbers
- Model No. 989605439241, 989605439242, 21381A, UDI: (01)00884838067547(21)B093BQ, (01)00884838067547(21)B0988T, (01)00884838067547(21)02P6MY, (01)00884838067547(21)039M2Q, (01)00884838067547(21)0319CQ +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 Mini Multi TEE Ultrasound Transducer is a specialized probe used in transesophageal echocardiography. It is deployed by clinicians during cardiac imaging procedures.
Why This Is Dangerous
The recall targets labeling intended to define the transducer’s useful life. The issue may lead to misuse if life expectancy is not clearly defined in the labeling.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics with the recalled units must verify identifiers and may need to halt use per recall instructions. The recall involves 11 units across the U.S., which could disrupt certain cardiac imaging workflows.
Practical Guidance
How to identify if yours is affected
- Compare device identifiers to the recall list: model numbers, UDIs, and serial numbers.
- Review labeling to confirm if the device is within scope of the recall.
- Consult procurement records for purchase details and batch information.
Where to find product info
FDA enforcement recall page at the provided link and Philips Ultrasound customer support site.
What timeline to expect
Remedy processing may take weeks. Philips will provide replacement or guidance after confirmation of identifiers.
If the manufacturer is unresponsive
- Document all communications with Philips support.
- Escalate to hospital risk management or procurement if responses are delayed.
How to prevent similar issues
- Verify labeling clearly states device life expectancy before purchase.
- Ask suppliers for updated labeling when procuring ultrasound transducers.
- Keep a log of device identifiers and recall notices for rapid verification.
Documentation advice
Retain recall notice, quotes of any communications, model numbers, serials, and dates of contact with Philips or healthcare providers.
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Product Details
Brand: Philips Ultrasound Product: Mini Multi TEE Ultrasound Transducer Models/Identifiers: 989605439241, 989605439242, 21381A, UDI: (01)00884838067547(21)B093BQ, (01)00884838067547(21)B0988T, (01)00884838067547(21)02P6MY, (01)00884838067547(21)039M2Q, (01)00884838067547(21)0319CQ, (01)00884838067547(21)B01639, Serial No.: 02GXR0, Additional SNs/UDIs: B093BQ, B0988T, 02P6MY, 039M2Q, 0341YT, 0319CQ, 028NZW, 02H0L8, B01639, 039M2M. Quantity recalled: 11 units Sold/distribution: US Nationwide distribution Recall date: 2025-09-05 Status: ACTIVE
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model numbers/Identifiers listed above
- US nationwide distribution
- Remedy: stop use; contact Philips Ultrasound for instructions
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