RegWardenFDA facility compliance records
Company

Pivotal Health Solutions, Inc.

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

Recalls by year

FDA actions on record by year2014: 1 recalls; 2024: 1 recalls; 2025: 1 recalls1’14’15’16’17’18’19’20’21’22’231’241’25’26
  • Recalls (3)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2025-10-09
    The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl cushion.
  • Class IIOngoing2024-04-29
    This product is being recalled due to potentially insufficient rework on a part (E7130-B) on the lumbar section of the frame on 6 distributed tables. There were 4 additional tables with the faulty E7130-B part that were manufactured, but had not been distributed yet.
  • Class IITerminated2014-12-17
    Control units were equipped with an internal mounting kit that does not meet medical safety standards, and are conductive, increasing the risk of electric shock to the user and patient. These units were manufactured prior to Pivotal Health Solutions acquisition of the Apollo prod…

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. “Pivotal Health Solutions, 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-10030456-pivotal-health-solutions-inc/

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