RegWardenFDA facility compliance records
Facility

KREG MEDICAL, INC.

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

Activity by year

FDA actions on record by year2012: 1 recalls; 2018: 1 inspections; 2025: 1 inspections1’12’13’14’15’16’171’18’19’20’21’22’23’241’25’26
  • Recalls (1)
  • Inspections (2)

Devices registered here (1)

  • Mattress, Air Flotation, Alternating Pressure
    Product code FNM (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5550

Recalls & enforcement

  • Class IITerminated2012-08-02
    An EZ Wider bed (capacity of 1000 lb. safe working load collapsed during patient use, leaving the patient in a forward tilt position.

FDA inspections (2)

  • NAI2025-10-15
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2018-01-23
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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.

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. “KREG MEDICAL, INC. (FEI 3005179379) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005179379-kreg-medical-inc/

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