RegWardenFDA facility compliance records
Facility

INTERNATIONAL BIOMEDICAL, LTD.

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

Activity by year

FDA actions on record by year2013: 1 recalls; 2016: 2 inspections1’13’14’152’16’17’18’19’20’21’22’23’24’25’26
  • Recalls (1)
  • Inspections (2)

Devices registered here (1)

Recalls & enforcement

  • Class IITerminated2013-05-24
    International Biomedical has received reports of interference between the collection bag and the extension set connectors. Evaluation of the affected components indicates that the collection bag connector can become occluded due to an over-tightening of the luer lock by the end u…

FDA inspections (2)

  • NAI2016-08-02
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
  • NAI2016-01-15
    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. “INTERNATIONAL BIOMEDICAL, LTD. (FEI 1000058335) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000058335-international-biomedical-ltd/

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