Z-1465-2022Class III

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

Name: Z-1465-2022 ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
Creator: Zeiss, Carl Inc
Published: 2022-06-24
License: https://open.fda.gov/license/

Carl Zeiss Microscopy, LLC / initiated 2022-06-24 / Terminated / root cause: manufacturing process

FDA source

Zeiss, Carl Inc began a recall of ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000 on 2022-06-24. FDA classified it as Class III and gives the reason as "An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1465-2022
Classification: Class III
Status: Terminated
Initiated: 2022-06-24
Posted: 2022-07-25
Terminated: 2025-02-07
Recalling firm: Carl Zeiss Microscopy, LLC
Product: ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
Product code: MTX Microscope And Microscope Accessories, Reproduction, Assisted
Reason for recall: An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.
Root cause tag: manufacturing process
FDA 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 in commerce: 1 US; 2 OUS
Distribution: US Nationwide distribution in the state of NY.
Product codes and lots: UDI-DI: 4064897000075 Serial Number: 3859001079

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1465-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1465-2022	Class III	Terminated	Voluntary: Firm initiated	2022-08-03	2022-07-25

Product code MTX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)