The FDA has posted 8 enforcement recalls from Tissium SA since 2025, none of them Class I (most serious). Most recent report: Aug 12, 2026.
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months.…
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months.…
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months.…
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months.…
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months.…
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months.…
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months.…
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26 months.…
Firm name as filed with the FDA: “TISSIUM SA”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.