RegWardenFDA facility compliance records
Facility

PROLLENIUM MEDICAL TECHNOLOGIES INC.

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

Activity by year

FDA actions on record by year2017: 1 inspections; 2018: 1 recalls, 1 inspections120172201820192020202120222023202420252026
  • Recalls (1)
  • Inspections (2)

Devices registered here (1)

  • Cannula, Surgical, General & Plastic Surgery
    Product code GEA (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4800

Recalls & enforcement

  • Class IITerminated2018-11-15
    Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.

FDA inspections (2)

  • VAI2018-11-01
    Voluntary Action Indicated · Project Evaluation: Devices · citations posted
  • NAI2017-04-20
    No Action Indicated · Bioresearch Monitoring

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “PROLLENIUM MEDICAL TECHNOLOGIES INC. (FEI 3004423487) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004423487-prollenium-medical-technologies-inc/

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