Food, drugs, devices › Zeiss, Carl Inc
Device recall: ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000
Zeiss, Carl Inc (Thornwood, NY) initiated this device recall on 24 Jun 2022; FDA lists 1 product record under event 90554, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 4% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 7 Feb 2025. Initiation: voluntary: firm initiated. Zeiss, Carl Inc has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Zeiss, Carl Inc, Thornwood, NY.
Reason for recall
"An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes."
Distribution
"US Nationwide distribution in the state of NY."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1465-2022 | ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000 | 1 US; 2 OUS | Class III | Terminated | 3 Aug 2022 |
Context
Other enforcement events for Zeiss, Carl Inc
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Oct 2019 | Component for Laser Scanning Microscopes (LSM 700, LSM 800 and LSM 900) | Device | Class II | 1 |
| 29 May 2018 | Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope | Device | Class II | 1 |
| 8 May 2018 | Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Mi | Device | Class II | 1 |
| 20 Dec 2013 | Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio I | Device | Class II | 1 |
| 28 May 2013 | Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of c | Device | Class II | 1 |
All 6 events for Zeiss, Carl Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the state of NY."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 7 Feb 2025. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.