HighFDA (Devices)·Z-1982-2025·Announced 2025-06-25

[pending] UROSKOP Omnia Max. Model Number: 10762473

Pending LLM rewrite. Source: FDA_DEVICE Z-1982-2025.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Model Number: 10762473. UDI Numbers: (01)04056869008981(21)4014
(01)04056869008981(21)4056
(01)04056869008981(21)4049
(01)04056869008981(21)4015
(01)04056869008981(21)4063
(01)04056869008981(21)4022
(01)04056869008981(21)4036
(01)04056869008981(21)4043
(01)04056869008981(21)4024
(01)04056869008981(21)4059
(01)04056869008981(21)4020
(01)04056869008981(21)4032
(01)04056869008981(21)4053
(01)04056869008981(21)4061
(01)04056869008981(21)4060
(01)04056869008981(21)4051
(01)04056869008981(21)4025
(01)04056869008981(21)4037
(01)04056869008981(21)4054
(01)04056869008981(21)4042

Distributed nationwide across the United States.

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