CooperVision Inc.
Complete recall history across all FDA and CPSC categories — 21 total recalls
CooperVision 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 (21)
FDA medical device enforcement actions by CooperVision Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| May 19, 2021 | CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact Lens wi... | Misaligned placement of an axis mark can cause the patient to experience blur... | Class II |
| May 19, 2021 | FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable Contact Lens... | Misaligned placement of an axis mark can cause the patient to experience blur... | Class II |
| May 19, 2021 | SOFMED BREATHABLES 1 DAY TORIC Power-07.00 -1.75/ 170 Daily Disposable C... | Misaligned placement of an axis mark can cause the patient to experience blur... | Class II |
| May 19, 2021 | CLARITI 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact Len... | Misaligned placement of an axis mark can cause the patient to experience blur... | Class II |
| May 19, 2021 | MEDIFLEX ELITE 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Con... | Misaligned placement of an axis mark can cause the patient to experience blur... | Class II |
| May 19, 2021 | CLARITI 1 DAY TORIC -DIAGNOSTIC Power-07.00 -1.75/170 Daily Disposabl... | Misaligned placement of an axis mark can cause the patient to experience blur... | Class II |
| May 19, 2021 | CLARITI 1 DAY TORIC Power -07.00 -1.25/180 Daily Disposable Contact Lens... | Misaligned placement of an axis mark can cause the patient to experience blur... | Class II |
| May 19, 2021 | CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Lens ... | Misaligned placement of an axis mark can cause the patient to experience blur... | Class II |
| May 19, 2021 | CLARITI 1 DAY TORIC Power -07.00 -1.75/170 Daily Disposable Contact Len... | Misaligned placement of an axis mark can cause the patient to experience blur... | Class II |
| May 19, 2021 | FRESH DAY 1 DAY TORIC Power -07.00 -1.25/010 Daily Disposable Contact L... | Misaligned placement of an axis mark can cause the patient to experience blur... | Class II |
| May 19, 2021 | AQUATECH PLUS 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact... | Misaligned placement of an axis mark can cause the patient to experience blur... | Class II |
| May 19, 2021 | SPECSAVERS UMERE TORIC Power -07.00 -1.25/180 Daily Disposable Contact Le... | Misaligned placement of an axis mark can cause the patient to experience blur... | Class II |
| Jan 13, 2020 | Coopervision Vertex Toric /2 Clear Toric- Power +2.25 -0.75/120 Soft (hydro... | Incorrect power of lenses than the expected | Class II |
| Jan 13, 2020 | Coopervision Vertex Toric /2 Clear Toric- Power -2.50 -0.75 /90 Soft (hydro... | Incorrect power of lenses than the expected | Class II |
| Feb 21, 2018 | 56% 1 Day Silicone Hydrogel (-2.50), 10 pack, UV Blocking, daily disposable ... | The secondary packaging is labeled with an incorrect expiration date. | Class III |
| Feb 21, 2018 | clariti 1 day/Fresh Day 90 pack (-1.00), UV Blocking, 90 silicon hydrogel, da... | The secondary packaging is labeled with an incorrect expiration date. | Class III |
| Feb 21, 2018 | 56% 1 Day Silicone Hydrogel (-4.50), 10 pack, UV Blocking, daily disposable ... | The secondary packaging is labeled with an incorrect expiration date. | Class III |
| Feb 21, 2018 | clariti 1 day (-1.25) 90 pack, UV Blocking, 90 silicone hydrogel, daily dispo... | The secondary packaging is labeled with an incorrect expiration date. | Class III |
| Sep 1, 2017 | Biofinity XR Toric contact lenses 8.7/14.5 - 6PK Biofinity XR Toric (com... | The firm identified a labeling error affecting Made-To-Order (MTO) Biofinity... | Class III |
| Nov 20, 2013 | ClearSight(TM) Toric 1 day (ocufilcon D), 30 daily disposable contact lenses ... | Lots were labeled with incorrect expiration dates on secondary package (carto... | Class II |
| Nov 20, 2013 | Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses,... | Lots were labeled with incorrect expiration dates on secondary package (carto... | 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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