RegWardenFDA facility compliance records
Company

ETHICON, LLC

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

Recalls by year

FDA actions on record by year2023: 1 recalls; 2024: 1 recalls; 2025: 1 recalls2017201820192020202120221202312024120252026
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IIOngoing2025-08-15
    Potential for barb non-engagement.
  • Class IIOngoing2024-10-08
    Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
  • Class IIOngoing2023-08-10
    Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.

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. “ETHICON, 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-10029715-ethicon-llc/

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