RegWardenFDA facility compliance records
Facility

MAST BIOSURGERY USA INC.

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

Activity by year

FDA actions on record by year2014: 1 recalls; 2018: 1 inspections; 2021: 1 inspections; 2025: 1 warning letters1’14’15’16’171’18’19’201’21’22’23’241’25’26
  • Recalls (1)
  • Inspections (2)
  • Warning letters (1)

Devices registered here (1)

Recalls & enforcement

  • Class IITerminated2014-08-26
    The expiration date of the bar code on the envelope label did not match the expiration date next to the hourglass. The printed expiration date was August of 2017, while the bar code date read as July 31, 2017. The correct expiration date was July 31, 2017.

FDA inspections (2)

  • NAI2021-11-19
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • VAI2018-09-13
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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.

FDA warning letters (1)

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

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. “MAST BIOSURGERY USA INC. (FEI 3004661493) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3004661493-mast-biosurgery-usa-inc/

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