RegWardenFDA facility compliance records
Company

Devicor Medical Products, Inc.

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

Recalls by year

FDA actions on record by year2016: 1 recalls; 2017: 1 recalls; 2020: 1 recalls; 2022: 1 recalls; 2026: 1 recalls1201612017201820191202020211202220232024202512026
  • Recalls (5)

Registered facilities (3)

Recalls & enforcement

  • Class IIOngoing2026-04-24
    Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.
  • Class IITerminated2022-03-30
    Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3.
  • Class IIITerminated2020-09-07
    It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01.
  • Class IITerminated2017-02-28
    The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
  • Class IITerminated2016-05-19
    A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.

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. “Devicor Medical Products, 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-10033297-devicor-medical-products-inc/

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