RegWardenFDA facility compliance records
Company

ADVANCED MEDICAL SOLUTIONS GROUP PLC

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

Recalls by year

FDA actions on record by year2015: 1 recalls; 2024: 1 recalls12015201620172018201920202021202220231202420252026
  • Recalls (2)

Registered facilities (7)

Recalls & enforcement

  • Class IIOngoing2024-10-01
    Due to defects on primary packaging pouch that compromise the device's ability to maintain a sterile barrier.
  • Class IITerminated2015-01-15
    On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its warehouse

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. “ADVANCED MEDICAL SOLUTIONS GROUP PLC — 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-9031453-advanced-medical-solutions-group-plc/

Not open yet

Alerts for ADVANCED MEDICAL SOLUTIONS GROUP PLC

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.