Unrated Medical device recall · FDA · Published July 8, 2021

Carl Zeiss Meditec recalls Cirrus HD-OCT Model 6000 due to lack of pre-market clearance

Carl Zeiss Meditec recalls Cirrus HD-OCT Model 6000 devices that were sold without proper pre-market clearance for high resolution tomographic imaging. Affected units have specific serial numbers listed in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2227-2021Medical device Carl Zeiss Meditec ›

Recall notice

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

Take action

Contact the company

Recalling firmCarl Zeiss Meditec, Inc.5160 Hacienda Dr · Dublin, CA 94568-7562

✎ GovInfoNow plain-language explainer

Carl Zeiss Meditec has recalled certain Cirrus HD-OCT Model 6000 devices because they were sold without proper pre-market clearance. This recall affects specific units with listed serial numbers and does not involve a safety hazard that could cause injury. Read more at govinfonow.com/recall/62235-carl-zeiss-meditec-recalls-cirrus-hd-oct-model-6000-due.

Source Summary by GovInfoNow · govinfonow.com/recall/62235-carl-zeiss-meditec-recalls-cirrus-hd-oct-model-6000-due · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2227-2021

Cite this page

“Carl Zeiss Meditec recalls Cirrus HD-OCT Model 6000 due to lack of pre-market clearance.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62235-carl-zeiss-meditec-recalls-cirrus-hd-oct-model-6000-due. Based on FDA recall #Z-2227-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2227-2021%22&limit=1).

The Food and Drug Administration announced on July 8, 2021, that Carl Zeiss Meditec, Inc. is recalling its CIRRUS HD-OCT Model 6000 imaging device due to failure to acquire pre-market clearance before commercialization.

How to tell if you have it

Brand: Carl Zeiss Meditec
Product: Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
Model Number: 6000
Material Number/Product Description: 266002-1173-109/SD-OCT 6000 NEW CM ENH1; 266002-1173-110/SD-OCT 6000 REFURB CM ENH1
Serial Numbers: 6000-10007 through 6000-11853 (as listed in record)
Units Affected: 914 systems

The hazard

The device is a high resolution tomographic/biomicroscope imaging unit distributed without required pre-market clearance, according to the FDA.

Context

GovInfoNow's records show Carl Zeiss Meditec has issued three other recalls since October 16, 2018. Other recent recalls of similar products include Edermy PIE PAK Models P2HC-A, P2HC-S, P2HC Recall: Lack of 510K Clearance (January 14, 2026) and Medline Syringes Recall: 510(k) Clearances Rescinded for Safety (February 25, 2026).

How to tell if you have this one

Check for the specific serial numbers listed in the recall notice, which include a range of numbers starting with '6000-'. The product label shows 'CIRRUS HD-OCT Model 6000' with the material number '266002-1173-109/SD-OCT 6000 NEW CM ENH1' or '266002-1173-110/SD-OCT 6000 REFURB CM ENH1'.

Brand
Carl Zeiss Meditec
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Your Device
Look for the serial numbers listed in the recall notice to determine if your device is affected.

Where it went and when

Where it was distributed

Distributed in 50 states and D.C. and Puerto Rico.

FDA 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.:…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 41 days after the firm started it.

Jul 8, 2021Firm started the recall
Aug 6, 2021FDA classified it Class II
Aug 18, 2021Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/62235-carl-zeiss-meditec-recalls-cirrus-hd-oct-model-6000-due">Carl Zeiss Meditec recalls Cirrus HD-OCT Model 6000 due to lack of pre-market clearance (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2227-2021 (July 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2227-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.