Carl Zeiss Meditec, Inc. recalls
Every recall we track for Carl Zeiss Meditec, Inc. — 4 in all, from 2018–2022 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
4 recalls since 2017.
All FDA recall records for Carl Zeiss Meditec, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 2 | 0 | 0 | 2 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 1 | 1 |
| 2022 | 0 | 0 | 0 | 1 | 1 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Carl Zeiss Meditec, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Carl Zeiss Meditec, Inc. recalls
4 shown- UnratedMedical device
Carl Zeiss Meditec, Inc. recalls CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
Carl Zeiss Meditec recalls CIRRUS HD-OCT models 5000 AngioPlex and 6000 AngioPlex with unapproved optic nerve head angiography scans. Affected units have specific software versions and serial numbers.
Carl Zeiss MeditecJan 14, 2022 - UnratedMedical device
Carl Zeiss Meditec, Inc. recalls Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
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.
Carl Zeiss MeditecJul 8, 2021 - Use cautionMedical device
Carl Zeiss Meditec, Inc. recalls VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the
Carl Zeiss Meditec recalls VisuMax software version 2.10.13 with activated ReLEx (SMILE) option due to potential incorrect corneal cuts during eye surgery. Affected devices may perform cap cuts instead of flap cuts, risking vision complications.
Carl Zeiss MeditecDec 6, 2018 - Use cautionMedical device
Carl Zeiss Meditec, Inc. recalls The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a
Carl Zeiss Meditec recalls 155 PLEX Elite 9000 Swept-Source OCT devices due to potential hazardous voltage exposure when contacting metal parts near the up/down switch during use.
Carl Zeiss MeditecOct 16, 2018
Carl Zeiss Meditec, Inc. recall questions
How many recalls has Carl Zeiss Meditec, Inc. had?
4 recalls from Carl Zeiss Meditec, Inc. are on record with U.S. safety agencies, from 2018–2022.
What is the most recent Carl Zeiss Meditec, Inc. recall?
Carl Zeiss Meditec, Inc. recalls CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex, dated Jan 14, 2022. Every Carl Zeiss Meditec, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Carl Zeiss Meditec, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Carl Zeiss Meditec, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.