RegWardenFDA facility compliance records
Facility

SteriGear, LLC

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

Activity by year

FDA actions on record by year2011: 1 recalls; 2017: 1 inspections; 2023: 1 inspections1’11’12’13’14’15’161’17’18’19’20’21’221’23’24’25’26
  • Recalls (1)
  • Inspections (2)

Devices registered here (1)

  • Urinary Drainage Collection Kit, For Indwelling Catheter
    Product code FCN (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5250

Recalls & enforcement

  • Class IITerminated2011-01-11
    SteriGear notifed customers of circumstances in which The Fig Leaf urinary drain bag valve can close creating a negative pressure that can suck the non-return valve closed.

FDA inspections (2)

  • NAI2023-03-22
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • NAI2017-03-06
    No Action Indicated · Compliance: 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. “SteriGear, LLC (FEI 3007608536) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007608536-sterigear-llc/

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