RegWardenFDA facility compliance records
Company

TISSIUM

1 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2026: 1 recalls20172018201920202021202220232024202512026
  • Recalls (1)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2026-06-15
    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. The use of a medical device beyond its validated shelf life may result in perioperative breakage of the device rendering device …

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “TISSIUM — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10093777-tissium/

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