RegWardenFDA facility compliance records
Company

DIVERSATEK HEALTHCARE INC

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

Recalls by year

FDA actions on record by year2021: 1 recalls; 2026: 1 recalls201720182019202012021202220232024202512026
  • Recalls (2)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2026-03-18
    The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
  • Class IITerminated2021-10-29
    M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling is correct.

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. “DIVERSATEK HEALTHCARE 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-2183446-diversatek-healthcare-inc/

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