CooperVision, Inc. recalls Sofmed Breathables

One lot manufactured with an invalid sterilization cycle.

CooperVision contacted consignees via telephone call and letter on 08/27/2025. Consignees were instructed to examine inventory and quarantine affected lot numbers, cease further distribution of product, and notify customers/patients if further distributed. Consignees were also requested to complete and return the Correction Response Form and arrange for the return of affected units.

• FDA enforcement recordOfficial FDA database entry for Z-2607-2025
• FDA 510(k) clearance · K131378The device's official FDA premarket clearance record
• FDA 510(k) clearance · K190965The device's official FDA premarket clearance record
• FDA 510(k) clearance · K220070The device's official FDA premarket clearance record
• FDA device classification · MVNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 886.5925The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find CooperVision, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.