The Recall Desk

Manufacturer

Carl Zeiss Meditec AG

11 recalls in our database name Carl Zeiss Meditec AG as the manufacturing or recalling firm.

What the numbers show

Total
11
Critical
0
Severe
1
Most recent
2026-07-08

Of the 11 recalls from Carl Zeiss Meditec AG we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (9%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–11 of 11

  • ModerateFDA (Devices)·Z-2649-2026·2026-07-08

    Zeiss Intrabeam Spherical Applicator failed manufacturing specifications

    Carl Zeiss Meditec AG is recalling Zeiss Intrabeam Spherical Applicator 1.5 cm units because they failed to meet manufacturing specifications.

    Product
    Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1007-2022·2022-05-04

    ZEISS miLOOP Lens Fragmentation Device Recalled for Slider Friction Issue

    Carl Zeiss Meditec is recalling the ZEISS miLOOP Lens Fragmentation Device due to high friction in the slider mechanism that may cause it to stick or fail to move as intended during cataract surgery.

    Product
    ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
    Category
    Medical Device
    Distribution
    32 states
  • SevereFDA (Devices)·Z-0614-2021·2020-12-23

    Carl Zeiss Meditec VISUREF 150 Recalled for Electrical Shock Risk

    Carl Zeiss Meditec is recalling 132 VISUREF 150 diagnostic instruments due to an incorrect component that may cause electrical shocks to users.

    Product
    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 assist the process of prescribing optical aids such as eyeglasses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0613-2021·2020-12-23

    Carl Zeiss Meditec VISULENS 550 Recalled for Electrical Shock Risk

    Carl Zeiss Meditec is recalling VISULENS 550 refractive power measurement devices due to a defective communication board that may cause electrical shocks.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2019·2018-10-24

    Carl Zeiss IOLMaster 700 Recalled for Incorrect Calibration Settings

    Carl Zeiss Meditec AG is recalling one IOLMaster 700 system because a manufacturing error caused incorrect calibration, leading to inaccurate eye images.

    Product
    Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0001-2018·2017-10-11

    Carl Zeiss INTRABEAM PRS 500 Radiation Therapy Devices Recalled for Calibration Error

    Carl Zeiss Meditec AG is recalling nine INTRABEAM PRS 500 radiation therapy devices because they had incorrect printed calibration values on their certificates.

    Product
    Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0357-2016·2015-12-09

    Carl Zeiss IOL Master 5.5 Software Recall for Incorrect Data

    Carl Zeiss Meditec AG is recalling IOL Master 5.5 software versions 7.5 and 7.7 because printouts and reports may contain incorrect IOL power data.

    Product
    IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ocular measurements and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0358-2016·2015-12-09

    Carl Zeiss IOL Master 500 Software Recall for Incorrect IOL Power Data

    Carl Zeiss Meditec is recalling IOL Master 500 software versions 7.5 and 7.7 because calculation printouts and exported reports may contain incorrect intraocular lens power data.

    Product
    IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 is intended for biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the vi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1049-2015·2015-02-11

    Carl Zeiss Meditec FORUM Archive and Viewer Software Recall

    Carl Zeiss Meditec is recalling FORUM Archive and Viewer software versions 3.1 and 3.2 due to a defect that may lead to misinterpretation of optical coherence tomography data.

    Product
    FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928 (USB drive wi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1153-2014·2014-03-19

    Carl Zeiss VisuMax Laser Keratome Treatment Packs Recalled for Size Mismatch

    Carl Zeiss Meditec AG is recalling VisuMax Laser Keratome treatment packs, Lot M130010, because Size M packs may contain Size S components.

    Product
    Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring
    Category
    Medical Device
    Distribution
    1 state