The Recall Desk

Manufacturer

American Contract Systems, Inc.

85 recalls in our database name American Contract Systems, Inc. as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–75 of 85

  • HighFDA (Devices)·Z-0175-2024·2023-11-01

    IV catheter components recalled for improper sterilization exposure

    American Contract Systems is recalling CVS PCSU SJH IV catheter and adhesive components due to improper ethylene oxide sterilization. The components may have reduced functionality or elevated chemical residuals.

    Product
    CVS PCSU SJH, REF SJCV48J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0180-2024·2023-11-01

    Sub Q Recorder Pack components may lose functionality due to improper sterilization

    American Contract Systems is recalling Sub Q Recorder Pack components that were improperly sterilized using ethylene oxide at excessive temperatures. The I.V. Cath and Dermabond components may lose functionality or drug efficacy as a result.

    Product
    Sub Q Recorder Pack, REF BPRC87A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0176-2024·2023-11-01

    Pediatric Heart SJH Device Recall Due to Improper Sterilization

    American Contract Systems recalls Pediatric Heart SJH components exposed to improper sterilization, risking functionality loss and reduced drug efficacy.

    Product
    Pediatric Heart SJH, REF SJPH34K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0182-2024·2023-11-01

    Cath Cardiac Pack sterilization failure may cause loss of functionality

    American Contract Systems recalled 1260 units of Cath Cardiac Pack due to improper sterilization exposure that may cause loss of functionality or higher ethylene oxide residuals.

    Product
    Cath Cardiac Pack, REF IHCC03V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0174-2024·2023-11-01

    Robotics Pack Sterilization Error Affects IV Catheter and Adhesive Components

    American Contract Systems recalls Robotics Pack SAH components due to improper sterilization exposure. The IV catheter and adhesive components may lack functionality or contain excess sterilization residue.

    Product
    Robotics Pack SAH, REF SAR530M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0177-2024·2023-11-01

    Cardiovascular Surgical Device Components Recalled for Improper Sterilization

    American Contract Systems recalls cardiovascular surgical device components that were subjected to improper ethylene oxide sterilization at excessive temperatures, potentially causing loss of functionality or drug efficacy.

    Product
    Vasc. Open CVOR SJH, REF SJVO56B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1973-2023·2023-06-21

    Total Knee Pack Medical Kits Recalled for Incorrect Expiration Date

    American Contract Systems is recalling 36 Total Knee Pack medical convenience kits distributed to Massachusetts due to an incorrect expiration date on the product labeling.

    Product
    Total Knee Pack, REF CETJ130, medical convenience kits
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0274-2023·2022-11-30

    Basin Set Medical Device Kit Contents Do Not Match Label

    American Contract Systems, Inc. is recalling a surgical basin set (MEBS42K) because the kit contents do not match the labeled contents. The mismatch could result in improper surgical preparation.

    Product
    BASIN SET, MEBS42K, general surgical kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0071-2023·2022-10-19

    COVID Test Kits Recalled for Incorrect Labeling and Device Incompatibility

    American Contract Systems is recalling COVID test kits incorrectly labeled for SARS-CoV-2 testing use. The 39,575 kits distributed in Pennsylvania should not be used with COVID devices.

    Product
    COVID Test Kit Nonsterile
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1695-2022·2022-09-14

    Cysto Packs Recalled Due to Inadequate Sterilization Validation

    American Contract Systems is recalling Cysto Packs distributed to health systems and distributors because the devices were exposed to multiple sterilization cycles without validation for multiple exposures.

    Product
    Various Cysto Packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1692-2022·2022-09-14

    PICC and Central Line Packs Exposed to Unvalidated Sterilization Cycles

    American Contract Systems is recalling PICC line and central line packs due to exposure to multiple sterilization cycles without validation. Two units were distributed to healthcare facilities in 13 U.S. states.

    Product
    Various PICC Line, Central Line Packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1693-2022·2022-09-14

    ENT Surgical Packs Recalled Due to Sterilization Validation Failure

    American Contract Systems recalls various ENT surgical packs that may not have been properly sterilized due to multiple sterilization cycles without adequate validation. The packs were distributed to healthcare facilities in 13 states.

    Product
    Various ENT Packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1700-2022·2022-09-14

    Neurology Surgical Packs Recalled for Sterilization Validation Failure

    American Contract Systems recalls 37 units of neurology surgical packs distributed across 13 US states due to exposure to multiple sterilization cycles without proper validation.

    Product
    Various neurology packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1689-2022·2022-09-14

    Angiography Packs Recalled Due to Sterilization Validation Failure

    American Contract Systems, Inc. is recalling 57 angiography packs and trays that were exposed to multiple sterilization cycles without proper validation for repeated sterilization exposure.

    Product
    Various Angiography packs/trays
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1705-2022·2022-09-14

    Eye Surgery Packs Recalled Due to Improper Sterilization Validation

    American Contract Systems is recalling various eye and cataract surgery packs distributed to US health systems because the products were exposed to multiple sterilization cycles without validation. Unvalidated sterilization may compromise device sterility.

    Product
    Various eye packs, cataract packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1704-2022·2022-09-14

    D&C Pack Recall Due to Sterilization Validation Failure

    American Contract Systems is recalling D&C packs that were exposed to multiple sterilization cycles without proper validation. The sterilization failure may compromise device sterility.

    Product
    D&C pack
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1698-2022·2022-09-14

    Medical device convenience packs exposed to unvalidated sterilization cycles

    American Contract Systems, Inc. is recalling 116 convenience packs distributed to U.S. health systems and distributors in 13 states because they were exposed to multiple sterilization cycles without validation, potentially compromising device sterility assurance.

    Product
    Various convenience packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1703-2022·2022-09-14

    C-Section Surgical Packs recalled for improper sterilization validation

    American Contract Systems recalls C-section surgical packs that were exposed to multiple sterilization cycles without validation. The sterilization integrity of the 24 affected units cannot be assured.

    Product
    Various C-section packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1696-2022·2022-09-14

    Port Insertion Packs Recalled Due to Unvalidated Sterilization

    American Contract Systems is recalling Various Port Insertion Packs that were exposed to multiple sterilization cycles without proper validation. The devices may not meet sterility standards.

    Product
    Various Port Insertion Packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1690-2022·2022-09-14

    Angiography and Catheterization Packs Recalled Due to Inadequate Sterilization Validation

    American Contract Systems is recalling 61 angiography and catheterization packs that were exposed to multiple sterilization cycles without proper validation. The affected packs were distributed to healthcare facilities in 13 U.S. states.

    Product
    Various Angiography/Cath Lab packs/trays
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1697-2022·2022-09-14

    Breast Abdominoplasty Pack Recalled for Inadequate Sterilization Cycle Validation

    American Contract Systems, Inc. is recalling Breast Abdominoplasty Packs that were exposed to multiple sterilization cycles without validation that the process could safely maintain instrument sterility through repeated exposures.

    Product
    Breast Abdominoplasty Pack
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1691-2022·2022-09-14

    Pacemaker and Cardiothoracic Surgical Packs Recalled for Improper Sterilization Validation

    American Contract Systems is recalling 24 units of pacemaker and cardiothoracic surgical packs distributed to health systems in multiple US states. Products were exposed to multiple sterilization cycles without proper validation.

    Product
    Various Pacemaker Packs, Cardio Thoracic Packs
    Category
    Medical Device
    Distribution
    13 states