Medical device recalls

Zeiss, Carl Inc recalls ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000

Recall date
June 24, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1465-2022
FDA classification
Class III
Brand / firm
Zeiss, Carl Inc
Sold / distributed
US Nationwide distribution in the state of NY.

Why it was recalled

An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000

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