RegWardenFDA facility compliance records
Company

Shape Medical Systems, Inc

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

Recalls by year

FDA actions on record by year2014: 2 recalls2’14’15’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (2)

Registered facilities (1)

Recalls & enforcement

  • Class IITerminated2014-12-23
    This recall has been initiated because use of the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment. The magnitude of error for VO2 or VCO2 parameters could be approximately 20% with use of the impacted prod…
  • Class IITerminated2014-05-28
    Shape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Cardiopulmonary Testing System prior to use of the impacted DPI lot numbers. Use of the incorrect software version with the impacted DPIs could result in erroneous testing results poten…

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. “Shape Medical Systems, 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-10029892-shape-medical-systems-inc/

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