Carl Zeiss Meditec, Inc.

Complete recall history across all FDA and CPSC categories — 10 total recalls

Carl Zeiss Meditec, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (10)

FDA medical device enforcement actions by Carl Zeiss Meditec, Inc.

Date Product Reason Class
Jan 14, 2022 CIRRUS HD-OCT, Models 5000 AngioPlex and 6000 AngioPlex Optic nerve head angiography scan to be turned off due to its distribution wi... Class II
Jul 8, 2021 Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRU... Due to failure to acquire pre-market clearance for its high resolution tomogr... Class II
Dec 6, 2018 VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE)... VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (... Class II
Oct 16, 2018 The PLEX Elite 9000, a Swept-Source OCT [SS-OCT] - Product Usage: The PLEX E... Under certain fault conditions, the existing design may expose the operator t... Class II
Oct 23, 2013 Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, ... The user database delivered for download contained an erroneous value. Specif... Class II
Oct 23, 2013 Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, ... The user database delivered for download contained an erroneous value. Specif... Class II
Apr 18, 2013 Zeiss brand OPMI Pentero C, Surgical microscope and accessories, Model: OPMI ... Carl Zeiss Meditec is conducting a field corrective action for its OPMI Pente... Class II
Oct 25, 2012 INTRABEAM Balloon Applicator Set; 4.0 cm, Carl Zeiss Meditec AG, Oberkochen... A manufacturing defect has been identified which could results in the small t... Class II
Oct 25, 2012 INTRABEAM Balloon Applicator Set; 3.0 cm, Carl Zeiss Meditec AG, Oberkochen... A manufacturing defect has been identified which could results in the small t... Class II
Oct 25, 2012 INTRABEAM Balloon Applicator Set; 3.5 cm, Carl Zeiss Meditec AG, Oberkochen... A manufacturing defect has been identified which could results in the small t... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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