CLASS III Device recall · Reported 3 Aug 2022 · FDA Enforcement Report
Zeiss Axio Observer 5 microscope recalled by Zeiss, Carl
Zeiss, Carl is recalling Zeiss Axio Observer 5 microscope, Product material no. 431006-9901-000, distributed nationwide in the US. The recall was initiated on 24 Jun 2022 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1465-2022
- FDA event ID
- 90554
- Recalling firm
- Zeiss, Carl, Thornwood, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 Jun 2022
- FDA classified
- 25 Jul 2022
- Reported
- 3 Aug 2022
- Type
- Voluntary: Firm initiated
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 24 Jun 2022 | Recall initiated by company | |
| 25 Jul 2022 | Classified by FDA | +31 days |
| 3 Aug 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.
Product as listed by the FDA
ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
Where it was distributed
US Nationwide distribution in the state of NY.
Questions about this recall
Is Zeiss Axio Observer 5 microscope, Product material no. 431006-9901-000 recalled?
Yes. Zeiss, Carl recalled Zeiss Axio Observer 5 microscope, Product material no. 431006-9901-000 on 24 Jun 2022. The recall is Class III and its status is Terminated. Recall number Z-1465-2022.
Why was it recalled?
An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.
Which lots are affected?
UDI-DI: 4064897000075 Serial Number: 3859001079
Where was it sold?
US Nationwide distribution in the state of NY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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