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. 989605440742, 989603002321, 989605388101, 989605440741, UDI: (01)00884838067615(21)033TVZ, (01)00884838067615(21)02Q8R3, (01)00884838067615(21)02VLZV, (01)00884838067615(21)02WND0 +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
This product is a diagnostic imaging transducer used with Philips ultrasound systems to capture high-frequency ultrasound images.
Why This Is Dangerous
The recall focuses on labeling and defining the device's useful life. There is no described immediate physical hazard in the notice.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals may pause use of affected transducers while labeling updates are issued; no injuries reported.
Practical Guidance
How to identify if yours is affected
- 1. Compare your transducer’s Model No. or UDI to the recall list.
- 2. Check for Serial No. 033TVZ and other identifiers (02Q8R3).
- 3. Quarantine any units that match the recall identifiers.
- 4. Contact Philips Ultrasound or your facility's risk management for guidance.
Where to find product info
FDA recall page and Philips Ultrasound customer service information.
What timeline to expect
The recall does not specify a replacement or refund timeline.
If the manufacturer is unresponsive
- File a report with your hospital risk management.
- Escalate to FDA recall enforcement if manufacturer delays guidance.
- Document all communications and responses.
How to prevent similar issues
- Verify labeling lifecycles before procurement.
- Request updated labeling documentation from suppliers.
- Maintain a tracking system for device IDs and lifecycles.
Documentation advice
Keep the recall notice, model/UDI identifiers, serial numbers, correspondence with Philips, and dates of any actions taken.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- US Nationwide distribution
- UDI codes and Serial No. 033TVZ included
- Recall issued 2025-09-05; Report date 2026-04-01
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.