RegWardenFDA facility compliance records
Company

ACIST MEDICAL SYSTEMS, INC.

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

Recalls by year

FDA actions on record by year2013: 1 recalls; 2015: 1 recalls; 2021: 1 recalls1’13’141’15’16’17’18’19’201’21’22’23’24’25’26
  • Recalls (3)

Registered facilities (1)

Recalls & enforcement

  • Class ITerminated2021-01-22
    Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-ring had the potential to be flushed out of the catheter. ACIST is confirming the source of the fail…
  • Class IITerminated2015-12-21
    Reports related to ingress of air into the manifold.
  • Class IITerminated2013-03-15
    ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Automated Manifold Kits. For these specific lots, ACIST has received field reports related to ingress of air into the manifold body. This has been detected by the Air Column Detect Sensor…

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. “ACIST MEDICAL SYSTEMS, 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-9028115-acist-medical-systems-inc/

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