FDA recall, , Low risk
Philips Ultrasound Transducers
Philips ultrasound transducers lack labelling to define their useful life.
Summary by Recall Canary from the FDA notice
What happened
Philips Ultrasound, Inc, of Reedsville, Pennsylvania, recalled multiple ultrasound transducers to provide clarification and labelling to define the useful life of ultrasound transducers in the field. The recall began September 5, 2025, was added to the FDA's Enforcement Report and classified on March 24, 2026, with US Nationwide distribution.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
11 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Philips L12-5 Ultrasound Transducer
- UDI-DI
- 989605412401
- 989605387311
- 989605418552
- 989605408173
- 989605438481
- 989605420231
- 00884838067851
- 00884838067974
Philips 3D6-2 Ultrasound Transducer
- UDI-DI
- 989605326521
- 989605440872
- 989605440871
- 00884838067714
Philips S4-1 Ultrasound Transducer
- UDI-DI
- 989605458221
- 989605458222
- 989605477101
- 00884838085183
- 00884838074231
- 00884838086579
Philips L17-5 Ultrasound Transducer
- UDI-DI
- 989605366371
- 989605388061
Philips Mini Multi TEE Ultrasound Transducer
- UDI-DI
- 989605439241
- 989605439242
- 00884838067547
Philips S5-2 Ultrasound Transducer
- UDI-DI
- 989605368393
- 00884838064638
Philips Omni II TEE Ultrasound Transducer
- UDI-DI
- 989605440792
- 00884838067660
Philips X3-1 Ultrasound Transducer
- UDI-DI
- 989605440742
- 989603002321
- 989605388101
- 989605440741
- 00884838067615
Philips C9-4 Ultrasound Transducer
- UDI-DI
- 989605365021
Philips Omni III TEE Ultrasound Transducer
- UDI-DI
- 989605440701
- 989605440702
- 989605440772
- 989803001561
- 00884838067585
- 00884838067646
Philips X7-2 Ultrasound Transducer
- UDI-DI
- 989605388121
- 989605347571
- 989605347573
- 00884838061729
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Philips Ultrasound, IncReedsville, Pennsylvania
- Hazard
- Labeling error
- Risk
Low risk
Using it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 97643
- Recall numbers
- Z-1618-2026 to Z-1628-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
