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American Contract Systems Inc recalls

The FDA has posted 43 enforcement recalls from American Contract Systems Inc since 2025, including 1 Class I (most serious) recall. Most recent report: May 13, 2026.

Class I: 1Class II: 42
Class IIOngoingZ-2472-2025

American Contract Systems Inc recalls AMERICAN CONTRACT SYSTEMS

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedur…

  • Orthopedic Tray
  • Under Investigation by firm
American Contract Syst…OHSep 3, 2025
Class IIOngoingZ-2466-2025

American Contract Systems Inc recalls AMERICAN CONTRACT SYSTEMS

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedur…

  • Endoscope Introducer Kit
  • Under Investigation by firm
American Contract Syst…OHSep 3, 2025
Class IIOngoingZ-2464-2025

American Contract Systems Inc recalls AMERICAN CONTRACT SYSTEMS

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedur…

  • Cardiovascular Procedure Kit
  • Under Investigation by firm
American Contract Syst…OHSep 3, 2025
Class IIOngoingZ-2470-2025

American Contract Systems Inc recalls AMERICAN CONTRACT SYSTEMS

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedur…

  • Gynecological Laparoscopic Kit
  • Under Investigation by firm
American Contract Syst…OHSep 3, 2025
Class IIOngoingZ-2468-2025

American Contract Systems Inc recalls AMERICAN CONTRACT SYSTEMS

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedur…

  • Neurological Tray
  • Under Investigation by firm
American Contract Syst…OHSep 3, 2025
Class IIOngoingZ-2471-2025

American Contract Systems Inc recalls AMERICAN CONTRACT SYSTEMS

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedur…

  • Hysterectomy Kit
  • Under Investigation by firm
American Contract Syst…OHSep 3, 2025
Class IIOngoingZ-2469-2025

American Contract Systems Inc recalls AMERICAN CONTRACT SYSTEMS

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedur…

  • Labor And Delivery Kit
  • Under Investigation by firm
American Contract Syst…OHSep 3, 2025
Class IIOngoingZ-2467-2025

American Contract Systems Inc recalls AMERICAN CONTRACT SYSTEMS

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedur…

  • General Surgery Tray
  • Under Investigation by firm
American Contract Syst…OHSep 3, 2025
Class IIOngoingZ-2465-2025

American Contract Systems Inc recalls AMERICAN CONTRACT SYSTEMS

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedur…

  • Laparoscopy Kit
  • Under Investigation by firm
American Contract Syst…OHSep 3, 2025
Class IIOngoingZ-1358-2025

American Contract Systems Inc recalls MAJOR VASCULAR PACK

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

  • Cardiovascular Procedure Kit
  • Process control
American Contract Syst…OHMar 26, 2025
Class IIOngoingZ-1338-2025

American Contract Systems Inc recalls LABOR & DELIVERY PACK

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

  • Labor And Delivery Kit
  • Process control
American Contract Syst…OHMar 26, 2025

Firm name as filed with the FDA: “American Contract Systems Inc”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.