RegWardenFDA facility compliance records
Company

F & L MEDICAL PRODUCTS LLC

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

Recalls by year

FDA actions on record by year2020: 1 recalls; 2023: 1 recalls201720182019120202021202212023202420252026
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2023-05-04
    Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes potential of injury.
  • Class IITerminated2020-01-20
    There is potential for the blister tray to be cracked causing the sterile barrier to be compromised and potential for particulate within the sterile barrier.

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. “F & L MEDICAL PRODUCTS 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-2529126-f-l-medical-products-llc/

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