Carl Zeiss Meditec AG
Complete recall history across all FDA and CPSC categories — 10 total recalls
Carl Zeiss Meditec AG 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 AG
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 16, 2022 | ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during catar... | High friction of the slider can cause the device to stick, or not move as int... | Class II |
| Dec 7, 2020 | IOLMaster 700 | When using software 1.90.2.09 or 1.90.8.06 and using modality worklist functi... | Class II |
| Aug 6, 2020 | Carl Zeiss Meditec Ag VISULENS 550 REF 2268-038 - Product Usage: is a device ... | Due to the incorrect DC/DC converter being assembled onto the communication b... | Class II |
| Aug 6, 2020 | Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnosti... | Due to the incorrect DC/DC converter being assembled onto the communication b... | Class II |
| Jun 25, 2018 | Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMa... | Calibration setting was incorrectly entered during manufacturing causing the ... | Class II |
| Aug 30, 2017 | Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the... | The device had an incorrect printed calibration value on the calibration cert... | Class II |
| Oct 27, 2015 | IOL Master 5.5: Software versions 7.5 and 7.7; Ophthalmic: used to obtain ... | IOL Master software versions 7.5 and 7.7 calculation printouts and exported r... | Class II |
| Oct 27, 2015 | IOL Master 500: Software versions 7.5 and 7.7; Ophthalmic: IOL Master 500 ... | IOL Master software versions 7.5 and 7.7 calculation printouts and exported r... | Class II |
| Jan 22, 2015 | FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3... | Software defect in the FORUM Viewer versions 3.1 and 3.2 which may lead to mi... | Class II |
| Feb 3, 2014 | Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured b... | Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain ... | 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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