RegWardenFDA facility compliance records
Facility

BIOMATLANTE

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

Activity by year

FDA actions on record by year2015: 1 recalls; 2018: 1 inspections; 2024: 1 recalls120152016201712018201920202021202220231202420252026
  • Recalls (2)
  • Inspections (1)

Devices registered here (1)

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

FDA inspections (1)

  • NAI2018-11-16
    No Action Indicated · Compliance: Devices

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. “BIOMATLANTE (FEI 3002673655) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002673655-biomatlante/

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