FDA Medical Device Recalls (openFDA)
Zeiss, Carl Inc: ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
- Recall number
- Z-1465-2022
- Recalling firm
- Zeiss, Carl Inc
- Product
- ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
- Status
- Terminated
- Initiated
- 2022-06-24
- Posted
- not on file
- Terminated
- 2025-02-07
- Reason
- An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.
- Root cause
- Process control
- Action
- On June 24, 2022, the firm notified their US customer of the recall via email. The customer was informed that a Zeiss service technician will contact them to arrange a date for performing a corrective action to eliminate the risk. The UDI label will be replaced.
- Quantity
- 1 US; 2 OUS
- Distribution
- US Nationwide distribution in the state of NY.
- Lot, serial or model codes
- UDI-DI: 4064897000075 Serial Number: 3859001079
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MTX
- Firm FEI
- 2431026
- Firm city
- Thornwood
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28