The Recall Desk

Manufacturer

Carl Zeiss Meditec, Inc.

10 recalls in our database name Carl Zeiss Meditec, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
10
Critical
0
Severe
0
Most recent
2022-03-16

Of the 10 recalls from Carl Zeiss Meditec, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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.

1–10 of 10

  • ModerateFDA (Devices)·Z-0723-2022·2022-03-16

    CIRRUS HD-OCT Optic Nerve Angiography Feature Requires Deactivation

    Carl Zeiss Meditec is recalling CIRRUS HD-OCT Models 5000 and 6000 AngioPlex devices. The optic nerve head angiography feature was distributed without FDA pre-market clearance and must be disabled.

    Product
    CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2227-2021·2021-08-18

    CIRRUS HD-OCT Model 6000 imaging devices recalled for missing FDA pre-market clearance

    Carl Zeiss Meditec is recalling 914 CIRRUS HD-OCT Model 6000 imaging devices. The manufacturer failed to obtain FDA pre-market clearance before selling the devices.

    Product
    Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-0770-2020·2020-01-08

    Carl Zeiss PLEX Elite 9000 Recalled for Electrical Shock Hazard

    Carl Zeiss Meditec is recalling 151 PLEX Elite 9000 Swept-Source OCT devices because a design fault may expose operators to hazardous voltage when contacting the metal enclosure.

    Product
    The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX Elite 9000 Swept-Source OCT [SS-OCT] is a non- contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dime
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0680-2020·2019-12-25

    VisuMax Software Recall for Incorrect Corneal Cut Type During Suction Loss

    Carl Zeiss Meditec is recalling VisuMax software version 2.10.13 because a defect may cause a cap cut instead of a flap cut if suction is lost during treatment.

    Product
    VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision ophthalm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0333-2014·2013-11-27

    Zeiss IOLMaster Recalled for Incorrect Lens Database Value

    Carl Zeiss Meditec is recalling 4,907 IOLMaster devices because an incorrect lens constant in the internal database could lead to the implantation of intraocular lenses with the wrong power.

    Product
    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primari
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0334-2014·2013-11-27

    Zeiss IOLMaster 500 Recalled for Erroneous Lens Database Value

    Carl Zeiss Meditec is recalling 1,201 IOLMaster 500 devices because an incorrect database value for the AMO Sensar AR40E lens could lead to the implantation of lenses with the wrong diopter.

    Product
    Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use prima
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1440-2013·2013-06-12

    Zeiss OPMI Pentero C Surgical Microscope Ceiling Mount Recall

    Carl Zeiss Meditec is recalling six OPMI Pentero C surgical microscopes because broken screws were found in the ceiling mounts during routine inspections.

    Product
    Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI Pentero C, Product Numbers: 302583-9001-000 (PENTERO C), and 305961-0000-00 (Ceiling Mount for PENTERO C), Product Usage: A surgical microscope and accessories is an AC-powered device intended for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0406-2013·2012-11-28

    INTRABEAM Balloon Applicator Set Recalled for Manufacturing Defect

    Carl Zeiss Meditec is recalling INTRABEAM Balloon Applicator Sets due to a manufacturing defect that could cause a small tube to become dislodged.

    Product
    INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0404-2013·2012-11-28

    Carl Zeiss Meditec Recalls INTRABEAM Balloon Applicator Sets

    Carl Zeiss Meditec is recalling 36 INTRABEAM Balloon Applicator Sets due to a manufacturing defect that could cause a small tube to become dislodged.

    Product
    INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0405-2013·2012-11-28

    Carl Zeiss Meditec Recalls INTRABEAM Balloon Applicator Sets Due to Manufacturing Defect

    Carl Zeiss Meditec is recalling 36 INTRABEAM Balloon Applicator Sets because a manufacturing defect could cause a small tube to become dislodged.

    Product
    INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen, Germany INTRABEAM System is intended for radiation therapy treatments.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Carl Zeiss Meditec

German Medical Company

Country
Germany
Founded
2002
Parent company
Carl Zeiss AG

Official website

Source: Wikidata (Q874182), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.