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.

151–175 of 199

  • HighFDA (Devices)·Z-0822-2024·2024-02-07

    Custom Surgical Procedure Kits Recalled for Improper Sterilization Assessment

    American Contract Systems is recalling 3,196 custom surgical procedure kits because sterilized components lacked documented suitability assessment. The components may have lost functionality or accumulated excessive sterilization residuals.

    Product
    Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP CHOLE - 213388, kit number BFLC02AD; d) GENERAL LAPAROSCOPY PACK, kit…
    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-0820-2024·2024-02-07

    Custom Ear, Nose and Throat Surgical Kits Recalled Due to Sterilization Validation Failure

    American Contract Systems is recalling 804 custom ear, nose and throat surgical kits nationwide because components were sterilized without validation that they could tolerate the process, potentially affecting functionality or drug efficacy.

    Product
    Custom procedural convenience kits and trays, ear, nose & throat, labeled as: a) T AND A PACK AGH ASC, kit number AGTA48J; b) OPSC EAR PACK, kit number LLEO66; c) T AND A PACK, kit number MMTA41F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0816-2024·2024-02-07

    Custom Anesthesia Kits Recalled Over Sterilization Validation Failure

    American Contract Systems recalls 182 anesthesia procedure kits due to improper sterilization assessment of added components. The kits may have compromised functionality, reduced drug efficacy, or elevated sterilant residue.

    Product
    Custom procedural convenience kits and trays, anesthesia, labeled as: a) HEART ANESTHESIA BUNDLE NS, Kit Number LMHA01V; b) OR/Anesthesia Central Line Insertion Kit, Kit Number UIAN43L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0831-2024·2024-02-07

    Custom OB/GYN Procedural Kits Recalled for Sterilization Process Failure

    American Contract Systems recalled 144 custom OB/GYN procedural kits after discovering components were sterilized without proper documentation, potentially losing functionality or efficacy. Affected units were distributed nationwide.

    Product
    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LavH, kit number BBLV21C; b) LAP HYST 247540, kit number BFHY75U
    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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0818-2024·2024-02-07

    Cardiac surgical kits recalled due to improper sterilization exposure

    American Contract Systems is recalling 12,291 cardiac procedure kits nationwide. Components were exposed to sterilization without documented assessment of suitability, potentially causing loss of functionality or efficacy.

    Product
    Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, kit number AGDI40J; c) LAB DEVICE IMPLANT, kit number AGDI40K; d) MINOR VASCULAR, kit number AGMV26O; e) OPEN HEART ACCESSORY, kit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0829-2024·2024-02-07

    Obstetrical Labor and Delivery Kits Recalled for Potential Functionality Loss

    American Contract Systems has recalled Labor and Delivery Packs because certain components may have lost functionality or efficacy due to unvalidated sterilization exposure.

    Product
    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LABOR & DELIVERY PACK, kit number HILD52F; b) LABOR & DELIVERY PACK, kit number HILD52G
    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-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-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-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-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-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-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-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
  • 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-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