RegWardenFDA facility compliance records
Company

DJO, LLC

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

Recalls by year

FDA actions on record by year2013: 1 recalls; 2015: 1 recalls; 2018: 1 recalls; 2019: 1 recalls; 2021: 1 recalls; 2025: 1 recalls; 2026: 1 recalls1’13’141’15’16’171’181’19’201’21’22’23’241’251’26
  • Recalls (7)

Registered facilities (11)

Recalls & enforcement

  • Class IIOngoing2026-03-19
    Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
  • Class IIOngoing2025-09-25
    The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capable of causing a second degree burn.
  • Class IOngoing2021-09-07
    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-…
  • Class IIOngoing2019-01-17
    The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.
  • Class IITerminated2018-06-25
    The device accessories were not labeled with appropriate latex warning.
  • Class IITerminated2015-08-21
    Overheating and burning of the wire insulation inside the applicator.
  • Class IITerminated2013-05-28
    DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlow 30B-B and 30 BI-B products. There is a potential for battery leakage which could result in thermal meltdown (fire).

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. “DJO, 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-9015378-djo-llc/

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