Genicon, Inc.
Complete recall history across all FDA and CPSC categories — 18 total recalls
Genicon, 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 (18)
FDA medical device enforcement actions by Genicon, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 17, 2020 | A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usag... | Device malfunction causing the applier to jam, and clip loading failures. | Class II |
| Aug 25, 2020 | Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigat... | The product design incorporating a motor driven impeller pump powered by one ... | Class II |
| Aug 21, 2018 | Genicon GENILook Model 200-005-251, 5mm diameter, 150mm length (one cannula, ... | There is potential for the plastic optical tip to become detached from the me... | Class II |
| Aug 21, 2018 | Genicon Natura Model 210-005-052, 5mm diameter, 70mm length (two cannula, thr... | There is potential for the plastic optical tip to become detached from the me... | Class II |
| Aug 21, 2018 | Genicon GENILook Model 200-105-152, 5mm diameter, 100mm length (2 cannula) - ... | There is potential for the plastic optical tip to become detached from the me... | Class II |
| Aug 21, 2018 | Genicon GENILook Model 200-105-251, 5mm diameter, 150mm length (1 cannula) - ... | There is potential for the plastic optical tip to become detached from the me... | Class II |
| Aug 21, 2018 | Genicon GENILook Model 200-105-252, 5mm diameter, 150mm length (2 cannula) - ... | There is potential for the plastic optical tip to become detached from the me... | Class II |
| Aug 21, 2018 | Genicon Natura Model 210-005-151; 5mm diameter, 100mm length (one cannula, th... | There is potential for the plastic optical tip to become detached from the me... | Class II |
| Aug 21, 2018 | Genicon Natura Model 210-005-251, 5mm diameter, 150mm length (one cannula, th... | There is potential for the plastic optical tip to become detached from the me... | Class II |
| Aug 21, 2018 | Genicon Natura Model 210-005-051; 5mm diameter, 70mm length (one cannula, thr... | There is potential for the plastic optical tip to become detached from the me... | Class II |
| Aug 21, 2018 | Genicon GENILook Model 200-005-153; 5mm diameter, 100mm length (three cannula... | There is potential for the plastic optical tip to become detached from the me... | Class II |
| Aug 21, 2018 | Genicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Pr... | There is potential for the plastic optical tip to become detached from the me... | Class II |
| Aug 21, 2018 | Genicon GENILook Model 200-005-151, 5mm diameter, 100mm length (one cannula, ... | There is potential for the plastic optical tip to become detached from the me... | Class II |
| Aug 21, 2018 | Genicon GENILook Model 200-105-151, 5mm diameter, 100mm length (one cannula) ... | There is potential for the plastic optical tip to become detached from the me... | Class II |
| Aug 21, 2018 | Genicon Natura Model 210-005-152, 5mm diameter, 100mm length (two cannula, th... | There is potential for the plastic optical tip to become detached from the me... | Class II |
| Aug 21, 2018 | Genicon GENILook Model 200-005-152, 5mm diameter, 100mm legnth (2 cannula, th... | There is potential for the plastic optical tip to become detached from the me... | Class II |
| Jun 27, 2018 | Genicon EZee Single Use Specimen Retrieval Bag - Product Usage: This device i... | Genicon is providing updated IFU labeling to users to provide clarity on how ... | Class II |
| Jul 19, 2017 | GENICON EZEE Retrieval, sterile, Rx only. | Plastic handle is breaking off of shaft inhibiting proper removal per Instruc... | 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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