RegWardenFDA facility compliance records
Company

Merz North America, Inc.

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

Recalls by year

FDA actions on record by year2015: 2 recalls; 2016: 1 recalls; 2020: 1 recalls220151201620172018201912020202120222023202420252026
  • Recalls (4)

Registered facilities (3)

Recalls & enforcement

  • Class IIOngoing2020-09-30
    The Instructions for Use (IFU) updated 03/02/2020 does not match data listed in the post-approval study.
  • Class IITerminated2016-05-20
    Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
  • Class IITerminated2015-10-26
    The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.
  • Class IITerminated2015-10-26
    The expiration date encoded in the UDI barcode on the label on the product carton and the peelable patient identification label is incorrect.

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. “Merz North America, Inc. — 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-9043404-merz-north-america-inc/

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