RegWardenFDA facility compliance records
Company

SOPHYSA

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

Recalls by year

FDA actions on record by year2024: 1 recalls; 2025: 1 recalls201720182019202020212022202312024120252026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2025-11-17
    Customer complaints of Pressio monitor rebooting.
  • Class IIOngoing2024-04-09
    An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of the catheter. In the event of a leak going undetected during implantation, it could pose an infectious risk to the patient. The cause of the leaks is indicated to be manufacturing error…

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. “SOPHYSA — 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-10023919-sophysa/

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