# FDA recall Z-2227-2021

> **Carl Zeiss Meditec, Inc.** · Class II · device recall initiated 2021-07-08.

## Product

Chassis Label - "CIRRUS HD-OCT Rx-Only"    Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"

## Reason for recall

Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing the device.

## Distribution

U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY    O.U.S.: N/A

## Key facts

- **Recall number:** Z-2227-2021
- **Recalling firm:** Carl Zeiss Meditec, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-07-08
- **Report date:** 2021-08-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dublin, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2227-2021

## Citation

> AI Analytics. FDA recall Z-2227-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2227-2021. Source: US FDA. Licensed CC0.

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