Philips L8-4 Transducer Probe labeling clarification on useful life
Philips Ultrasound is recalling 171,322 L8-4 Transducer Probes to provide clarification and labeling defining the useful life of the ultrasound transducers.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall for a labeling and documentation issue with no reported illnesses or injuries. The hazard is documentation-related rather than a physical safety defect, consistent with the rubric classification of documentation issues as Low severity.
Plain-English summary
Philips Ultrasound, Inc. is recalling 171,322 L8-4 Transducer Probes distributed nationwide in the United States. The recall is being issued to provide clarification and labeling that defines the useful life of ultrasound transducers in the field. Users of affected transducers should review the updated labeling from Philips to understand the defined useful life and follow appropriate maintenance and replacement protocols.
The recalled product
- Product
- L8-4 Transducer Probe
- Manufacturer
- Philips Ultrasound, Inc
- Hazard
- mis-labeling
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 (20)
- Model No. 989605440812
- 989605387331
- 8500-1659-01
- UDI: (01)00884838067684(21)B16YF8
- (01)00884838067684(21)B16YCT
- (01)00884838067684(21)B1LJXF
- (01)00884838067684(21)B1LJXB
- (01)00884838067684(21)B0QY2W
- (01)00884838067684(21)B0NBTB
- (01)00884838067684(21)B2X79D
- (01)00884838067684(21)B1M6RD
- (01)00884838067684(21)B16YF2
- (01)00884838067684(21)B2PFP4
- (01)00884838067684(21)B1M6QR
- (01)00884838067684(21)B2PFPC
- (01)00884838067684(21)B0QY57
- (01)00884838067684(21)B36JJ4
- (01)00884838067684(21)B11679
- (01)00884838067684(21)B0L7X8
- (01)00884838067684(21)B1M6QV
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- HighGE CARESCAPE Telemetry Server may lose patient ECG and oxygen saturation monitoring
FDA (Devices) · 2026-06-03