RegWardenFDA facility compliance records
Company

SMISSON-CARTLEDGE BIOMEDICAL LLC

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

Recalls by year

FDA actions on record by year2021: 1 recalls20172018201920201202120222023202420252026
  • Recalls (1)

Registered facilities (1)

Recalls & enforcement

  • Class ITerminated2021-02-18
    Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.

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. “SMISSON-CARTLEDGE BIOMEDICAL LLC — 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-9097032-smisson-cartledge-biomedical-llc/

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