Quick Facts at a Glance
- Recall Date
- September 5, 2025
- Hazard Level
- HIGH
- AI Risk Assessment
- LOW
- Brand
- Philips Ultrasound
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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. 989605458221, 989605458222, 989605477101, UDI: (01)00884838085183(21)B25VV3, (01)00884838085183(21)B21XVK, (01)00884838085183(21)B1ZJVG, (01)00884838085183(21)B2D31R, (01)00884838085183(21)B21XXK +12 more
- Sold at
- Unknown
- 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 S4-1 ultrasound transducer is used in medical imaging to obtain diagnostic ultrasound images. Hospitals and clinics rely on such transducers daily for patient care.
Why This Is Dangerous
The hazard relates to labeling clarifications about the useful life of the transducer, not an explicit functional defect or immediate patient harm in the notice.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The recall affects hospital equipment inventories and requires immediate stop-use actions and adherence to manufacturer instructions to ensure proper lifecycle management.
Practical Guidance
How to identify if yours is affected
- 1) Compare your inventory against the listed model numbers and UDIs.
- 2) Check packaging for S4-1 designation and any labeling updates from Philips.
- 3) Cross-check with your recall communications from Philips or the FDA page.
Where to find product info
FDA recall page for Z-1625-2026 and Philips recall notices.
What timeline to expect
Remediation timelines vary by facility; manufacturers typically coordinate replacements or updates within weeks to months.
If the manufacturer is unresponsive
- Escalate with hospital procurement and regulatory affairs
- Document all requests and responses
- Contact FDA consumer product safety Office if manufacturer is unresponsive.
How to prevent similar issues
- Maintain up-to-date labeling and lifecycle records for ultrasound transducers
- Implement standard operating procedures for lifecycle management
- Verify future device labeling and lifecycle information at receipt
Documentation advice
Document inventory checks, correspondence with Philips, and any remediation actions taken.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 41 total units recalled
- Class III recall
- Distribution: United States nationwide
- UDIs span multiple codes listed in recall data
- Regulatory status: ACTIVE
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Safety Guide
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