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. 989605368393, (01)00884838064638(21)B0C824, Serial No. B0C824.
- 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 S5-2 Ultrasound Transducer is a diagnostic imaging component used with Philips ultrasound systems to emit and receive sound waves for medical imaging.
Why This Is Dangerous
The recall focuses on clarifying labeling to define the transducer’s useful life in field use. It is not described as an immediate operational hazard but affects lifecycle management.
Industry Context
This recall is not identified as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics must verify labeling and lifecycle guidance for the S5-2 transducer. The immediate action is to stop use and seek replacement or guidance according to Philips.
Practical Guidance
How to identify if yours is affected
- 1. Compare your transducer to Model No. 989605368393 and Serial No. B0C824.
- 2. Check for the presence of label or lifecycle information matching the recall.
- 3. If matched, stop use and contact Philips Ultrasound for instructions.
- 4. Follow any provided recall instructions and document actions taken.
Where to find product info
FDA enforcement page for Z-1626-2026 and Philips recall notice.
What timeline to expect
Recall does not specify a timeline for remedy. Follow manufacturer communications for next steps.
If the manufacturer is unresponsive
- Escalate to hospital risk management or the FDA MedWatch program.
- Keep records of outreach attempts and local regulatory guidance.
How to prevent similar issues
- Verify labeling for life expectancy on ultrasound transducers before deployment.
- Maintain a tracking system for device lifecycle and recalls.
- Choose replacement transducers from Philips that comply with current labeling guidelines.
Documentation advice
Keep the recall notice, serial/model numbers, correspondence with Philips, and any replacement instructions as part of your asset records.
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Product Details
Model No. 989605368393; (01)00884838064638(21)B0C824; Serial No. B0C824. Distribution: US Nationwide. Recall date: 2025-09-05. Report date: 2026-04-01. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Model No. 989605368393; Serial No. B0C824
- Distributed nationwide in the US
- Recall date 2025-09-05; Report date 2026-04-01
- Remedy: Stop using; follow manufacturer instructions
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