RegWardenFDA facility compliance records
Company

CUSTOMED, INC.

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

Recalls by year

FDA actions on record by year2014: 2 recalls; 2015: 1 recalls; 2016: 1 recalls2’141’151’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (4)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2016-01-07
    Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
  • Class IITerminated2015-07-10
    Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
  • Class ITerminated2014-10-08
    Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
  • Class ITerminated2014-05-20
    Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.

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. “CUSTOMED, 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-9000786-customed-inc/

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