Chassis Label — Class II medical device recall Z-2227-2021
Ongoing recall by Carl Zeiss Meditec, Inc., reported 2021-08-18, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Due to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging devic
| Recall number | Z-2227-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Carl Zeiss Meditec, Inc., Dublin, CA, United States |
| Recall initiated | 2021-07-08 |
| Classified | 2021-08-06 |
| Reported by FDA | 2021-08-18 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, GU, 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Quantity | 914 systems |
| Serial numbers | 6000-10004, 6000-10005, 6000-10007, 6000-10008, 6000-10010, 6000-10011, 6000-10012, 6000-10013, 6000-10015, 6000-10016, 6000-10017, 6000-10020, 6000-10021, 6000-10022, 6000-10023, 6000-10024, 6000-10025, 6000-10026, 6000-10028, 6000-10029, 6000-10031, 6000-10032, 6000-10034, 6000-10038, 6000-10039 and 475 more |
| Model numbers | 6000, ENH1 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2227-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.