The Recall Desk

Manufacturer

American Contract Systems, Inc.

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

What the numbers show

Total
196
Critical
0
Severe
3
Most recent
2026-09-02

Of the 196 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 3 (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.

151–175 of 196

  • HighFDA (Devices)·Z-0832-2024·2024-02-07

    Ophthalmic procedural kits recalled due to inadequate sterilization validation

    American Contract Systems is recalling 940 ophthalmic surgical kits nationwide due to undocumented components that may lack functionality, drug efficacy, or contain elevated sterilization residuals.

    Product
    Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27; b) Laminectomy, kit number UIOL34AG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0819-2024·2024-02-07

    Cardiac central line insertion kits lack documented sterilization validation

    American Contract Systems is recalling 290 cardiac procedural kits nationwide because components were subjected to sterilization without documented assessment of temperature suitability, potentially causing loss of functionality or efficacy.

    Product
    Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; b) Adult Central Line Insertion Supply Kit, kit number UICL44N; c) Pediatric Central Line Insertion, kit number UIPL77K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0833-2024·2024-02-07

    Orthopedic surgical kits recalled for unassessed external component sterilization

    American Contract Systems recalls 5,524 orthopedic surgical kits due to unassessed sterilization of external components that may lose functionality, drug efficacy, or have excess sterilization chemical residue.

    Product
    Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HIP FRACTURE, kit number AHHF15D; c) Hand Pack, kit number BBHP10E; d) Lower Extremity, kit number BBLE40B; e) Custom Podiatry, kit number BOCP70J; f) ROB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0817-2024·2024-02-07

    Custom Cardiac Procedural Kits Recalled for Inadequate Sterilization Assessment

    American Contract Systems is recalling 4394 custom cardiac procedural kits due to components added without proper assessment for sterilization exposure, which may result in loss of functionality or drug efficacy.

    Product
    Custom procedural convenience kits and trays, cardiac, labeled as: a) HEART CATHETERIZATION TRAY, kit number JRHC45G; b) TAVR PACK, kit number LLTV10; c) CATH PED LF SJH, kit number SJCA21F; d) CATH HEART ADL LF SJH, kit number SJCH22F; e) INT RAD PORTS-LF - 206060, ki
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0828-2024·2024-02-07

    Obstetrical and Gynecological Surgical Kits Recalled for Sterilization Assessment Defects

    American Contract Systems is recalling 1,020 obstetrical and gynecological surgical kits because components were sterilized without documented assessment of their suitability to the process, potentially causing loss of functionality or drug efficacy.

    Product
    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G; c) DAVINCI GYN PACK, kit number HHDV17; d) KIT, GYNE ROBOTIC, kit number MMGR44D;
    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
  • HighFDA (Devices)·Z-0172-2024·2023-11-01

    Medical device components subjected to improper sterilization process and elevated exposure

    American Contract Systems is recalling LAVH surgical component kits because two components were subjected to improper sterilization temperatures and ethylene oxide exposure, potentially causing loss of functionality and higher chemical residuals.

    Product
    LAVH, REF BBLV21C
    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-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-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-0181-2024·2023-11-01

    Pediatric Urology Equipment Recalled Due to Improper Sterilization

    American Contract Systems is recalling Pediatric Urology Wolson Packs due to components being exposed to unapproved sterilization processes. Components may have lost functionality or reduced efficacy, potentially compromising device performance.

    Product
    Pediatric Urology Wolson Pack, REF BPPU55A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0171-2024·2023-11-01

    Medical Device Packs Recalled for Improper Sterilization Process

    American Contract Systems recalled General Pack medical device components (I.V. catheters and adhesive) that were improperly sterilized with ethylene oxide at higher than approved temperatures. The components may lack functionality or have elevated sterilization residuals.

    Product
    General Pack, REF BBGP31C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0179-2024·2023-11-01

    Robotics Pack I.V. Catheter and Adhesive Recalled for Sterilization Defect

    American Contract Systems is recalling its Robotics Pack (56 cases) due to improper sterilization of IV catheter and adhesive components. The devices may have lost functionality or drug efficacy and may contain excessive ethylene oxide residuals.

    Product
    Robotics Pack, REF SSRO22D
    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
  • 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-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-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-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