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. 989605412401, 989605387311, 989605418552, 989605408173, 989605438481, 989605420231, UDI: (01)00884838067851(21)B27H7T, (01)00884838067974(21)B0B0B1 +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
Ultrasound transducers are handheld devices used with ultrasound systems to capture diagnostic images. The L12-5 is a specified model in Philips’ range used in medical imaging.
Why This Is Dangerous
The recall focuses on clarifying the labeling related to the device's useful life rather than an acute malfunction. The labeling clarification is intended to prevent improper servicing or use past defined life.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
No injuries reported. Immediate action required to prevent potential misinterpretation of device life and servicing timelines.
Practical Guidance
How to identify if yours is affected
- Identify device labeling for model L12-5 and compare with the affected model numbers and serials listed.
- Cross-check UDI codes provided in the recall with your device labeling.
- If any match, set aside devices and contact Philips for next steps.
Where to find product info
Refer to the FDA enforcement page linked in the recall notice and Philips recall communications.
What timeline to expect
Recall instructions will be provided by Philips. No explicit replacement timeline is given in the notice.
If the manufacturer is unresponsive
- Document all attempts to contact Philips or your healthcare provider.
- Escalate to hospital compliance or device-reprocessing team if needed.
How to prevent similar issues
- Verify labeling and life-span information before servicing or replacing transducers.
- Keep all recall notifications and letters for records.
- Use only Philips-supported channels for recall communications.
Documentation advice
Save the recall letter, note model/serial numbers, and all correspondence with Philips or providers.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Serial Nos. B107H4, B106RJ, B02RKJ
- UDI codes listed in recall
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Safety Guide
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