Sofmed Breathables recall
Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel…
Why was Sofmed Breathables recalled?
One lot manufactured with an invalid sterilization cycle.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Carton Lot Number: 20735504301008. Blister Lot Number: 6450505898
- Product
- Sofmed Breathables, (stenfilcon A) contact lens. Model Number: Softmed Breathables. 54% water content, Toric, cast moulded Silicone Hydrogel…
- Recalling firm
- CooperVision, Inc.
- Quantity
- 180 units
- Distribution
- US Nationwide distribution in the states of Florida, Kentucky, North Carolina, and Wisconsin.
- Recall date
- October 1, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)