# FDA recall Z-0183-2024

> **Carl Zeiss Suzhou Co., Ltd.** · Class II · device recall initiated 2023-08-18.

## Product

OPMI LUMERA 300, REF 6137

## Reason for recall

Surgical microscope for use in ophthalmology may be missing a screw from the suspension arm, which may cause the suspended components to fall from the suspension arm, which may injure any person under the suspended components.

## Distribution

US Nationwide distribution in the states of MD, TX, CA, GA, LA.

## Key facts

- **Recall number:** Z-0183-2024
- **Recalling firm:** Carl Zeiss Suzhou Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-08-18
- **Report date:** 2023-11-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Suzhou, N/A, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0183-2024

## Citation

> AI Analytics. FDA recall Z-0183-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0183-2024. Source: US FDA. Licensed CC0.

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