- Recalling firm
- CooperVision, Inc.
- Reason for recall
- The affected products bear an incorrect statement on the carton packaging indicating that the product is "Indicated for Extended Wear". However, this product is intended for daily wear, and the extended-wear statement should not have appeared on the affected carton labeling. This product is not approved by the U.S. Food and Drug Administration (FDA) for extended wear use.
- Affected products (lot / model / serial)
- Model/Catalog Number: Softmed Breathables Advanced Toric; UDI-DI: N/A Lot numbers: 19486120027517, 19486120030515, 19486120035532, 19486120051506, 19486170015507, 19486170016513, 19486170016521, 19486170017507, 19486170017509, 19486170017512, 19486170019512, 19486170019514, 19486170021021, 19486170021518, 19486170022503, 19486170022504, 19486170023528, 19486170025508, 19486170026021, 19486170027034, 19486170027504, 19486170027524, 19486170028518, 19486170030023, 19486170030034, 19486170031023, 19486170031034, 19486170032030, 19486170032036, 19486170032504, 19486170033501, 19486170034001, 19486170034032, 19486170034038, 19486170039040, 19486170040030, 19486170041032, 19486170042018, 19486170042032, 19486170043003, 19486170043028, 19486170043030, 19486170043032, 19486170043502, 19486170044017, 19486170045011, 19486170047002, 19486170047007, 19486170047011, 19486170048011, 19486170049004, 19486170049006, 19486170049009, 19486170049011, 19486170050003, 19486170050004, 19486170050007, 19486170050019, 19486170051002, 19486170051006, 19486170051024, 19486170052002, 19486170052005, 19486170052009, 19486170052015, 19486170053015, 19486170053024, 19486170054015, 19486170054016, 19486170055000, 19486170055018, 19486170055026, 19486170056000, 19486170056014, 19486170057005, 19486170059018, 19486170060008, 19486170060012, 19486170060014, 19486170061008, 19486170061014, 19486170061018, 19486170064014, 19486170065008, 19486170068010, 19486170069010, 19487120020526, 19487120026512, 19487120027506, 19487120043038, 19487120046502, 19487120048036, 19487120051003, 19487120061007, 19487120067007, 19487120071014, 19487120075016, 19487120077016, 19487120079014, 19487120080014, 19487170006516, 19487170012505, 19487170015501, 19487170016524, 19487170017030, 19487170019503, 19487170022001, 19487170022021, 19487170023021, 19487170025011, 19487170026019, 19487170028011, 19487170028013, 19487170029019, 19487170030017, 19487170030019, 19487170031026, 19487170031028, 19487170031032, 19487170032011, 19487170032017, 19487170032024, 19487170033005, 19487170033009, 19487170034002, 19487170034015, 19487170035002, 19487170035022, 19487170036020, 19487170037000, 19487170037011, 19487170038005, 19487170038018, 19487170039018, 19487170040000, 19487170042000, 19487170044000, 19487170047006, 19487170048012, 19487170053008, 19488120012522, 19488120015512, 19488120017519, 19488120023021, 19488120030013, 19488120032017, 19488120033028, 19488120034005, 19488120035018, 19488120037018, 19488120042020, 19488120044000, 19488170005507, 19488170006504, 19488170007501, 19488170007507, 19488170010508, 19488170015015, 19488170016032, 19488170019026, 19488170020009, 19488170021004, 19488170022004, 19488170022006, 19488170022014, 19488170024012, 19488170028016, 19488170028026, 19489120015504, 19489120015512, 19489120019009, 19489120019021, 19489120019036, 19489120024040, 19489120027007, 19489120027018, 19489120027024, 19489120029020, 19489120030000, 19489120031016, 19489120036006, 19489170005508, 19489170009030, 19489170010002, 19489170010010, 19489170012003, 19489170014028, 19490120013023, 19490120024002, 19490120024005, 19490120025007, 19490120026013, 19490170003508, 19490170007524, 19490170008501, 19490170012004, 19490170015006, 19490170015010, 19491120017021, 19491120017511, 19491120026014, 19491120034012, 19491120037008, 19491170004508, 19491170006503, 19491170007503, 19491170008504, 19491170016024, 19491170017002, 19491170021000, 19492120009511, 19492120010034, 19492120026024, 19492120027018, 19492120034011, 19492120048000, 19492120052000, 19492170004518, 19492170005520, 19492170018010, 19492170022002, 19492170022005, 19492170024008, 19492170025001, 19492170027003, 19492170027004, 19492170028002, 19492170028004, 19493120013513, 19493120015512, 19493120017518, 19493120021020, 19493120022028, 19493120022030, 19493120026018, 19493120026506, 19493120037013, 19493120042501, 19493120045009, 19493170006017, 19493170010015, 19493170010016, 19493170010017, 19493170010507, 1949317001300
- Units affected
- 230856
- Distribution pattern
- US Nationwide distribution in the states of FL, KY, MI.
- Firm location
- West Henrietta, NY, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0204-2027
- Recall initiated
- September 22, 2026
- FDA classification date
- October 22, 2026
- FDA report date
- October 28, 2026
- FDA event ID
- 99936
- Last updated on HTM Vibe
- November 3, 2026
