RegWardenFDA facility compliance records
Company

Epimed International, Inc.

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

Recalls by year

FDA actions on record by year2016: 1 recalls; 2017: 2 recalls; 2019: 1 recalls; 2020: 1 recalls; 2021: 1 recalls1201622017201812019120201202120222023202420252026
  • Recalls (6)

Registered facilities (2)

Recalls & enforcement

  • Class IITerminated2021-02-01
    Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off
  • Class IITerminated2020-02-21
    Incorrect expiration date on introduction cannula packaging.
  • Class IITerminated2019-06-18
    Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.
  • Class IICompleted2017-12-28
    Potential for stylet to protrude from the distal end of the catheter
  • Class IITerminated2017-07-24
    Potential for partially incomplete seal of product, impacting sterility.
  • Class IITerminated2016-04-22
    There is a possibility that the needles may have the potential to skive a catheters outer coating. If this were to occur, there exists the risk that a portion of the catheter could remain in the patient, which may require otherwise unnecessary medical invention.

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. “Epimed International, Inc. — 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-1316297-epimed-international-inc/

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