Browse Device Recalls
21 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 21 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 21 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 blurred vision | Class II | CooperVision Inc. |
| 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 blurred vision | Class II | CooperVision Inc. |
| 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 blurred vision | Class II | CooperVision Inc. |
| 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 blurred vision | Class II | CooperVision Inc. |
| 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 blurred vision | Class II | CooperVision Inc. |
| 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 blurred vision | Class II | CooperVision Inc. |
| 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 blurred vision | Class II | CooperVision Inc. |
| 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 blurred vision | Class II | CooperVision Inc. |
| 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 blurred vision | Class II | CooperVision Inc. |
| 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 blurred vision | Class II | CooperVision Inc. |
| 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 blurred vision | Class II | CooperVision Inc. |
| 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 blurred vision | Class II | CooperVision Inc. |
| 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 | CooperVision Inc. |
| 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 | CooperVision Inc. |
| 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 | CooperVision Inc. |
| 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 | CooperVision Inc. |
| 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 | CooperVision Inc. |
| 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 | CooperVision Inc. |
| 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 XR Toric blister la... | Class III | CooperVision Inc. |
| 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 (carton). The primary pac... | Class II | CooperVision Inc. |
| 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 (carton). The primary pac... | Class II | CooperVision Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.