Philips Ultrasound, Inc

Philips Ultrasound, Inc: 132 FDA recall reports

Every medical device recall the FDA has published for Philips Ultrasound, Inc. The fault, and how the agency graded it.

132Reports
0Class I
102Ongoing
2026-04-01Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

ClassWhat the FDA is saying
Class IThere is a reasonable probability that using this will cause serious harm or death.
Class IIIt may cause temporary or reversible harm. Serious harm is unlikely.
Class IIIIt breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

ClassReports
Class III80
Class II52

By year reported

YearReports
20146
20155
20162
20191
20204
20219
20233
20241
202590
202611
Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Philips S5-2 Ultrasound Transducer

Z-1626-2026  ·  Class III  ·  reported 2026-04-01  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
Philips S5-2 Ultrasound Transducer
Where it went
US Nationwide distribution.
How much
1 unit

Philips S4-1 Ultrasound Transducer

Z-1625-2026  ·  Class III  ·  reported 2026-04-01  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
Philips S4-1 Ultrasound Transducer
Where it went
US Nationwide distribution.
How much
41 units

Philips X3-1 Ultrasound Transducer

Z-1627-2026  ·  Class III  ·  reported 2026-04-01  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
Philips X3-1 Ultrasound Transducer
Where it went
US Nationwide distribution.
How much
17 units

Philips OMNI II TEE Ultrasound Transducer

Z-1623-2026  ·  Class III  ·  reported 2026-04-01  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
Philips OMNI II TEE Ultrasound Transducer
Where it went
US Nationwide distribution.
How much
2 units

Philips L17-5 Ultrasound Transducer

Z-1621-2026  ·  Class III  ·  reported 2026-04-01  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
Philips L17-5 Ultrasound Transducer
Where it went
US Nationwide distribution.
How much
2 units

Philips Mini Multi TEE Ultrasound Transducer

Z-1622-2026  ·  Class III  ·  reported 2026-04-01  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
Philips Mini Multi TEE Ultrasound Transducer
Where it went
US Nationwide distribution.
How much
11 units

Philips OMNI III TEE Ultrasound Transducer

Z-1624-2026  ·  Class III  ·  reported 2026-04-01  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
Philips OMNI III TEE Ultrasound Transducer
Where it went
US Nationwide distribution.
How much
75 units

Philips 3D6-2 Ultrasound Transducer

Z-1618-2026  ·  Class III  ·  reported 2026-04-01  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
Philips 3D6-2 Ultrasound Transducer
Where it went
US Nationwide distribution.
How much
17 units

Philips X7-2 Ultrasound Transducer

Z-1628-2026  ·  Class III  ·  reported 2026-04-01  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
Philips X7-2 Ultrasound Transducer
Where it went
US Nationwide distribution.
How much
5 units

Philips C9-4 Ultrasound Transducer

Z-1619-2026  ·  Class III  ·  reported 2026-04-01  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
Philips C9-4 Ultrasound Transducer
Where it went
US Nationwide distribution.
How much
1 unit

Philips L12-5 Ultrasound Transducer

Z-1620-2026  ·  Class III  ·  reported 2026-04-01  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
Philips L12-5 Ultrasound Transducer
Where it went
US Nationwide distribution.
How much
40 units

TRANSDUCER L12-5 Transducer Probe

Z-2402-2025  ·  Class III  ·  reported 2025-09-03  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
TRANSDUCER L12-5 Transducer Probe
Where it went
US Nationwide distribution.
How much
171,322 units

C6-2 Transducer Probe

Z-2355-2025  ·  Class III  ·  reported 2025-09-03  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
C6-2 Transducer Probe
Where it went
US Nationwide distribution.
How much
171,322 units

L12-5 38mm Transducer Probe

Z-2375-2025  ·  Class III  ·  reported 2025-09-03  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
L12-5 38mm Transducer Probe
Where it went
US Nationwide distribution.
How much
171,322 units

C8-4v Transducer Probe

Z-2358-2025  ·  Class III  ·  reported 2025-09-03  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
C8-4v Transducer Probe
Where it went
US Nationwide distribution.
How much
171,322 units

L9-3 Transducer Probe

Z-2382-2025  ·  Class III  ·  reported 2025-09-03  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
L9-3 Transducer Probe
Where it went
US Nationwide distribution.
How much
171,322 units

X7-2 Transducer Probe

Z-2411-2025  ·  Class III  ·  reported 2025-09-03  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
X7-2 Transducer Probe
Where it went
US Nationwide distribution.
How much
171,322 units

S9-2 Transducer Probe

Z-2399-2025  ·  Class III  ·  reported 2025-09-03  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
S9-2 Transducer Probe
Where it went
US Nationwide distribution.
How much
171,322 units

C8-5 Transducer Probe

Z-2359-2025  ·  Class III  ·  reported 2025-09-03  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
C8-5 Transducer Probe
Where it went
US Nationwide distribution.
How much
171,322 units

mC7-2 Transducer Probe

Z-2384-2025  ·  Class III  ·  reported 2025-09-03  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
mC7-2 Transducer Probe
Where it went
US Nationwide distribution.
How much
171,322 units

C5-2 Lumify Transducer Probe

Z-2354-2025  ·  Class III  ·  reported 2025-09-03  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
C5-2 Lumify Transducer Probe
Where it went
US Nationwide distribution.
How much
171,322 units

X6-1 Transducer Probe

Z-2410-2025  ·  Class III  ·  reported 2025-09-03  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
X6-1 Transducer Probe
Where it went
US Nationwide distribution.
How much
171,322 units

C9-3v Transducer Probe

Z-2362-2025  ·  Class III  ·  reported 2025-09-03  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
C9-3v Transducer Probe
Where it went
US Nationwide distribution.
How much
171,322 units

L12-4 Transducer Probe

Z-2373-2025  ·  Class III  ·  reported 2025-09-03  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
L12-4 Transducer Probe
Where it went
US Nationwide distribution.
How much
171,322 units

BP10-5ec Transducer Probe

Z-2349-2025  ·  Class III  ·  reported 2025-09-03  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
BP10-5ec Transducer Probe
Where it went
US Nationwide distribution.
How much
171,322 units

SCNHD LA L7-4 HDI Transducer Probe

Z-2400-2025  ·  Class III  ·  reported 2025-09-03  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
SCNHD LA L7-4 HDI Transducer Probe
Where it went
US Nationwide distribution.
How much
171,322 units

L8-4 Transducer Probe

Z-2381-2025  ·  Class III  ·  reported 2025-09-03  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
L8-4 Transducer Probe
Where it went
US Nationwide distribution.
How much
171,322 units

7.5MHZ Endo Transducer Probe

Z-2348-2025  ·  Class III  ·  reported 2025-09-03  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
7.5MHZ Endo Transducer Probe
Where it went
US Nationwide distribution.
How much
171,322 units

L10-4LAP Transducer Probe

Z-2370-2025  ·  Class III  ·  reported 2025-09-03  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
L10-4LAP Transducer Probe
Where it went
US Nationwide distribution.
How much
171,322 units

C10-4ec Transducer Probe

Z-2351-2025  ·  Class III  ·  reported 2025-09-03  ·  Ongoing

Why it was recalled
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Product
C10-4ec Transducer Probe
Where it went
US Nationwide distribution.
How much
171,322 units

Showing the 30 most recent of 132. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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