The Recall Desk

Manufacturer

American Contract Systems, Inc.

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

What the numbers show

Total
199
Critical
0
Severe
4
Most recent
2026-10-07

Of the 199 recalls from American Contract Systems, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (2%) are Severe.

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.

176–199 of 199

  • 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-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-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-1701-2022·2022-09-14

    Obstetric and gynecology surgical packs recalled for unvalidated sterilization exposure

    American Contract Systems is recalling 15 obstetric and gynecology surgical packs that underwent multiple sterilization cycles without validation. This could compromise product sterility and increase infection risk during procedures.

    Product
    Various ob/gyn packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1702-2022·2022-09-14

    Hysterectomy and Vaginal Packs Recalled for Improper Sterilization Validation

    American Contract Systems recalled 29 hysterectomy and vaginal packs distributed to health systems in 13 states due to exposure to multiple sterilization cycles without validation.

    Product
    Various hysterectomy, vaginal packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1699-2022·2022-09-14

    Surgical instrument convenience packs recalled for inadequate sterilization validation

    American Contract Systems is recalling 118 convenience packs of surgical instruments because they were exposed to multiple sterilization cycles without validation of the product's ability to withstand repeated sterilizations.

    Product
    Various convenience packs
    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
  • 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-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-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
  • SevereFDA (Devices)·Z-1277-2022·2022-07-13

    COVID-19 nasopharyngeal sample collection tray recalled due to improper assembly

    American Contract Systems, Inc. recalls 274,400 COVID-19 test kits distributed in Minnesota due to off-site assembly by individuals who may not have been properly trained.

    Product
    Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1276-2022·2022-07-13

    Clean Catch Urine Kit Recalled Due to Improper Assembly

    American Contract Systems is recalling 274,400 Clean Catch Urine Kits due to improper assembly by potentially untrained individuals. The FDA classified this as a Class I recall.

    Product
    Clean Catch Urine Kit NS 178489, AHMU58A
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1036-2022·2022-05-18

    Spine Surgery Instrument Sets Recalled for Sterilization Defect

    American Contract Systems is recalling ACS Spine Pack and ACS Lumbar/Back Set Up Tray surgical instrument sets due to improper sterilization with excess ethylene oxide. The affected sets were distributed in Illinois, Missouri, Nebraska, and Texas.

    Product
    1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1038-2022·2022-05-18

    ACS IR Angio Pack Sterilization Process Defect Recall

    The ACS IR Angio Pack from American Contract Systems, Inc. was sterilized using ethylene oxide at higher than specification concentration. No illnesses or injuries have been reported.

    Product
    ACS IR - Angio Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1037-2022·2022-05-18

    Surgical Device Kits Recalled Due to Improper Sterilization Process

    American Contract Systems is recalling ACS Arthroscopy, Knee, and Hand surgical kits because they were sterilized using a higher than specification ethylene oxide concentration.

    Product
    1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1040-2022·2022-05-18

    ACS Cath Lab Packs Sterilized with Excess Ethylene Oxide

    American Contract Systems recalls ACS Cath Lab Packs distributed in IL, MO, NE, and TX because they were sterilized with higher than specification ethylene oxide concentrations.

    Product
    ACS Cath Lab Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0964-2019·2019-03-06

    FDA Recalls Surgical Convenience Kits Due to Potential Sterilization Failure

    American Contract Systems, Inc. is recalling 51,152 surgical convenience kits distributed in Florida because they may not have reached complete sterilization.

    Product
    Bag size #4 Custom Convenience Kits Usage: Surgical convenience kits labeled as the following: a. Tray Name: PACK BASIC SET UP LH - 2035102, Tray Number: LSRBASICPACD; b. Tray Name: PACK ANGIOGRAM CFH - 2071297, Tray Number: LSRCFHANGD; c. Tray Name: PACK…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0456-2019·2018-11-21

    American Contract Systems Recalls Powdered Surgical Gloves

    American Contract Systems is recalling 1,180 kits of powdered surgical gloves because they are an FDA banned substance.

    Product
    Powdered Surgical Gloves, labeled as: a. Baxter and Ansell brand Powdered Surgical Gloves b. Powdered Surgical Gloves included in ACS surgical convenience kits Health care personnel rely on medical gloves as barriers against transmission of infectious diseases and…
    Category
    Medical Device
    Distribution
    4 states