RegWardenFDA facility compliance records
Company

Perouse Medical

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

Recalls by year

FDA actions on record by year2012: 1 recalls; 2014: 1 recalls; 2017: 1 recalls1’12’131’14’15’161’17’18’19’20’21’22’23’24’25’26
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2017-04-05
    Complaints regarding broken blister.
  • Class IITerminated2014-10-06
    Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure
  • Class IITerminated2012-05-10
    Perouse Medical in France initiated a voluntary recall of certain batches of Perouse FLAMINGO Inflations Devices due to a potential water-tightness default. The potential default could cause an air entry when the plunger is positioned around 20 mL.

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. “Perouse Medical — 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-10024483-perouse-medical/

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