Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2056-2025·Announced 2025-07-09

Philips L8-4 Ultrasound Transducers Recalled for Refurbishment Beyond Useful Life

Philips Ultrasound is recalling 5,230 L8-4 transducer units that were refurbished beyond their useful life, which may affect device safety and performance. The units were distributed nationwide and internationally.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: This is an FDA Class II recall. The source states the devices were refurbished beyond their useful life, which is a quality/durability issue rather than a known safety hazard with reported injuries or illnesses. No adverse events are reported in the source text.

Plain-English summary

Philips Ultrasound, Inc. is recalling the Philips L8-4 Transducer (Model Nos. 989605440811, 989605440812). According to the FDA, the devices were refurbished beyond their useful life.

Approximately 5,230 units were affected by this recall. The devices were distributed domestically nationwide and internationally to countries including Australia, Canada, China, France, Germany, India, Japan, Mexico, South Korea, the United Kingdom, and others.

Users of affected transducers should contact Philips Ultrasound, Inc. for instructions on return or replacement. Additional information is available from the FDA's Medical Device Recalls database at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=Z-2056-2025.

The recalled product

Product: Philips L8-4 Transducer.
Manufacturer: Philips Ultrasound, Inc
Category: Medical Device — Ultrasound Transducer
Hazard: device-degradation
Affected units: 5,230

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. 989605440811
989605440812
UDI: (01)00884838067684(21)B0LZNN
(01)00884838067684(21)03BPVM
(01)00884838067684(21)02KMFZ
(01)00884838067684(21)02HJDK
(01)00884838067684(21)02FWNQ
(01)00884838067684(21)02KKZT
(01)00884838067684(21)03H7GL
(01)00884838067684(21)02LTKK
(01)00884838067684(21)02H2JM
(01)00884838067684(21)02KKVB
(01)00884838067684(21)038XYV
(01)00884838067684(21)02DLVR
(01)00884838067684(21)02CCM5
(01)00884838067684(21)02LT6G
(01)00884838067684(21)02KMKK
(01)00884838067684(21)02V8VD
(01)00884838067684(21)037Z2B
(01)00884838067684(21)02NK5J

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 21 recalled by Philips Ultrasound, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 21 products in this recall →

Same manufacturer · Philips Ultrasound, Inc

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