FDA (Devices) recall action 97217
The FDA (Devices) publishes a recall like this one as 69 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 69 pages.
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
C10-3v Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
OMNI II TEE Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
C9-3v Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
S4-1 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
S8-3 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
X5-1c Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
S3-1 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
L15-7io Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
C6-2 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
C5-2 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
eL18-4 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
X3-1 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
L10-4LAP Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
mL26-8 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
C9-4v Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
S7-2t Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
L12-4 Lumify Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Mini Multi TEE Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
BP10-5ec Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
D2TCD Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
X7-2t Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
D5cwc Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
The L15-7IO Transducer Probe is the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
mC12-3 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
S12-4 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.