Philips eL18-4 Ultrasound Transducers Recalled for Defective Refurbishment
Philips Ultrasound is recalling Philips eL18-4 Transducers because they were refurbished beyond their useful life, which may affect device performance and patient safety.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA classified this as a Class II recall. The source states the transducers were refurbished beyond their useful life, which is a manufacturing/maintenance defect rather than an acute contamination or hazard with reported injuries. No illnesses or injuries are reported in the source text.
Plain-English summary
Philips Ultrasound, Inc. is recalling the Philips eL18-4 Transducer (Model No. 989605456291 and 989605431531) because the devices were refurbished beyond their useful life.
Approximately 5,230 units have been distributed nationwide in the United States and internationally to Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Nicaragua, Oman, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United Arab Emirates, Venezuela, and Vietnam.
If you have one of these transducers, contact Philips Ultrasound, Inc. immediately for instructions on replacement or repair. Do not continue to use a device that may no longer function reliably.
The recalled product
- Product
- Philips eL18-4 Transducer.
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- device-defect
- refurbishment-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Model No.989605456291
- 989605431531
- UDI: (01)00884838070813(21)B2JXFM
- (01)00884838070813(21)B25L9M
- (01)00884838070813(21)B25LJ0
- (01)00884838070813(21)B25LY7
- (01)00884838070806(21)B29W04
- Serial No. B2JXFM
- B25L9M
- B28MJZ
- B25LJ0
- B25LY7
- B29W04.
Distribution
Distributed nationwide across the United States.
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