RegWardenFDA facility compliance records
Facility

GI SUPPLY

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

Activity by year

FDA actions on record by year2016: 1 recalls; 2018: 1 inspections1201620171201820192020202120222023202420252026
  • Recalls (1)
  • Inspections (1)

Devices registered here (1)

  • Intrauterine Tamponade Balloon
    Product code OQY (opens in a new tab) · Class II · Obstetrics/Gynecology · 21 CFR 884.4530

Recalls & enforcement

  • Class IITerminated2016-01-28
    Customers have reported that the pinch clamp on the RP Bag was missing. Ascetic fluid from the abdominal cavity may splash User if bag is not clamped prior to removal.

FDA inspections (1)

  • NAI2018-12-18
    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. “GI SUPPLY (FEI 1000121355) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000121355-gi-supply/

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