CLASS II ONGOING Device recall · Reported 16 Mar 2022 · FDA Enforcement Report
Cirrus Hd-oct recalled by Carl Zeiss Meditec
Carl Zeiss Meditec is recalling Cirrus Hd-oct, distributed nationwide in the US. The recall was initiated on 14 Jan 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0723-2022
- FDA event ID
- 89524
- Recalling firm
- Carl Zeiss Meditec, Dublin, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Jan 2022
- FDA classified
- 4 Mar 2022
- Reported
- 16 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 14 Jan 2022 | Recall initiated by company | |
| 4 Mar 2022 | Classified by FDA | +49 days |
| 16 Mar 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
Product as listed by the FDA
CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Where it was distributed
U.S Nationwide Distribution.: OH, CA, IN, AR, IA, LA, WI, OK, IL, OR, AL, KY, WY, WA, MN, NE, PA, SD, AZ, PR, TN, GA, FL, DE, NY, NH, TX, MS, MA, NV, UT, WV, ME, CO, AK, NM, KS, MO, MI, MD, ID, CT, NJ, MT, NC, VA, HI, VT, ND, SC, DC, RI
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Is Cirrus Hd-oct recalled?
Yes. Carl Zeiss Meditec recalled Cirrus Hd-oct on 14 Jan 2022. The recall is Class II and its status is Ongoing. Recall number Z-0723-2022.
Why was it recalled?
Optic nerve head angiography scan to be turned off due to its distribution without pre-market clearance.
Which lots are affected?
All instrument serial numbers running running software versions 11.5, 11.5.1 and 11.5.2. with ONH Angiography 4.5x4.5mm Scan
Where was it sold?
U.S Nationwide Distribution.: OH, CA, IN, AR, IA, LA, WI, OK, IL, OR, AL, KY, WY, WA, MN, NE, PA, SD, AZ, PR, TN, GA, FL, DE, NY, NH, TX, MS, MA, NV, UT, WV, ME, CO, AK, NM, KS, MO, MI, MD, ID, CT, NJ, MT, NC, VA, HI, VT, ND, SC, DC, RI
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Carl Zeiss Meditec
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Chassis Label - "Cirrus Hd-oct Rx-Only" Product Label recalled | Carl Zeiss Meditec | Device Malfunction | 52 states |
| Device | CLASS II | The Plex Elite 9000, a Swept-Source Oct [Ss-oct] recalled | Carl Zeiss Meditec | Foreign Material | Nationwide |
| Device | CLASS II | VisuMax Software Version recalled by Carl Zeiss Meditec | Carl Zeiss Meditec | Device Malfunction | Nationwide |
| Device | CLASS II | Zeiss IOLMaster recalled by Carl Zeiss Meditec | Carl Zeiss Meditec | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Zeiss IOLMaster recalled by Carl Zeiss Meditec | Carl Zeiss Meditec | Lead & Heavy Metals | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |