Jena, N/A, Germany
Carl Zeiss Meditec AG recalls
5 recalls recorded since 2018, most recently on 1 June 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)2
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 1 June 2026
- Reason
- Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
- Distribution
- Worldwide - US Nationwide distribution in the state and territories of Florida and Puerto Rico. The countries of China, Germany, Ecuador, Spain, France, Malaysia, Philippines, Poland, and Romania.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2649-2026
- Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Ongoing Class II Medical devices
- Recall started
- 16 March 2022
- Reason
- High friction of the slider can cause the device to stick, or not move as intended.
- Distribution
- U.S.: AL, AR, AZ, CA, CT, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NJ, NY, OH, OR, PA, Puerto Rico, SC, TN, TX. UT, VA, WA, and WV O.U.S.: Not provided
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1007-2022
- ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
Terminated Class II Medical devices
- Recall started
- 7 December 2020
- Terminated
- 24 June 2022
- Reason
- When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functionality for patient data transfer, the selection of the patient in the patient list may not match the patient information displayed on the right side of the screen
- Distribution
- U.S.: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, TX, UT, VA, VT, WA, WI, and WV. O.U.S.: Austria, Australia, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, France, United Kingdom,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1133-2021
Terminated Class II Medical devices
- Recall started
- 6 August 2020
- Terminated
- 13 December 2024
- Reason
- Due to the incorrect DC/DC converter being assembled onto the communication board. As a result the effectiveness of the communication board cannot be guaranteed in that the safety function of the board would be insufficient resulting in an increased leakage of current and potentially cause electrical shocks to the user.
- Distribution
- Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD, MI, MN, NC, NE, NJ, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, TX, UT, VA, WA and WY. The countries of Argentina, Austria, Australia, Belgium, Bolivia, C
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0614-2021, Z-0613-2021
- Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values and keratometric characteristics of the human eye. The results are used to assis
- Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device for measuring the refractive power of contact lenses and spectacle lenses and displaying measurement values for sphere, cylinder and prism.
Terminated Class II Medical devices
- Recall started
- 25 June 2018
- Terminated
- 15 January 2021
- Reason
- Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures of the anterior and posterior segments of the eye.
- Distribution
- US: CA (Mountain View and San Jose) A single system. No distributed OUS.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0108-2019
- Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.