RegWardenFDA facility compliance records
Facility

ADVANCED MEDICAL BALLOONS GMBH

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

Activity by year

FDA actions on record by year2018: 1 recalls; 2023: 1 recalls201712018201920202021202212023202420252026
  • Recalls (2)

Devices registered here (1)

  • Tubes, Gastrointestinal (And Accessories)
    Product code KNT (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5980

Recalls & enforcement

  • Class IIOngoing2023-10-23
    A small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive which is not declared on the label
  • Class IITerminated2018-12-05
    A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbonate Mouthpaste (cosmetic) tubes.

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. “ADVANCED MEDICAL BALLOONS GMBH (FEI 3015237508) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3015237508-advanced-medical-balloons-gmbh/

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