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.

76–100 of 196

  • HighFDA (Devices)·Z-3244-2024·2024-10-02

    Pacemaker COPM11B Medical Kits Recalled for Sterilization Verification Issue

    American Contract Systems is recalling 3 units of the COPM11B pacemaker medical kits due to inability to confirm sterilization requirements were met. An inoperable chart recorder caused humidity readings to exceed specifications during manufacturing.

    Product
    Pacemaker, COPM11B; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3230-2024·2024-10-02

    American Contract Systems Recalls Open Shoulder Medical Convenience Kits

    American Contract Systems is recalling 12 Open Shoulder medical convenience kits because a faulty chart recorder prevented verification of sterilization requirements.

    Product
    Open Shoulder, LWOS39L; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3228-2024·2024-10-02

    Endovascular AAA Pack recalled for sterilization assurance failure

    American Contract Systems recalls 360 units of Endovascular AAA Pack due to inability to confirm sterilization requirements were met. An inoperable chart recorder prevented verification that environmental conditions during sterilization met required specifications.

    Product
    Endovascular AAA Pack, ESED52B; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3243-2024·2024-10-02

    Medical device kit recalled due to inability to confirm sterilization assurance

    American Contract Systems recalled its Cysto medical convenience kit (36 units, Lot 2405033) due to a humidity monitoring failure that prevented confirmation of adequate product sterilization.

    Product
    Cysto, FTCY03L; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3235-2024·2024-10-02

    IR Procedure Pack Recalled Due to Sterilization Assurance Failure

    American Contract Systems recalls IR Procedure Pack (Lot 2405102, expiration 05/10/2024) because it cannot confirm sterilization requirements were met. An inoperable chart recorder caused humidity levels to be out-of-specification.

    Product
    IR Procedure Pack, CEAT19W; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3242-2024·2024-10-02

    Nasal Sinus Pack Recalled Due to Sterilization Verification Failure

    American Contract Systems is recalling Nasal Sinus Pack units due to manufacturing control failures that prevent confirmation of sterilization. Affected units were distributed to multiple states.

    Product
    Nasal Sinus Pack, MTSN26B; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3233-2024·2024-10-02

    Bilateral Tubal Ligation Pack Recalled for Unconfirmed Sterilization

    American Contract Systems, Inc. is recalling the Bilateral Tubal Ligation Pack (Lot 2405102) due to inability to confirm proper sterilization following a chart recorder malfunction.

    Product
    Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3234-2024·2024-10-02

    Medical Paracentesis Kit Recalled Over Sterilization Assurance Failure

    504 paracentesis kits (Lot 2405102) are being recalled because the manufacturer cannot confirm that sterilization requirements were met during production.

    Product
    Paracentesis Thoracente, SLPT76H; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3239-2024·2024-10-02

    Medical Cath Lab Pack Recalled Due to Sterilization Assurance Failure

    American Contract Systems is recalling Cath Lab Pack CECL02P medical kits because an inoperable chart recorder caused humidity readings to be out-of-specification, preventing confirmation that sterilization requirements were met.

    Product
    Cath Lab Pack, CECL02P; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3227-2024·2024-10-02

    Endovascular AAA Packs Recalled Due to Sterilization Process Defect

    American Contract Systems is recalling 93 units of Endovascular AAA Packs due to inability to confirm sterilization assurance requirements were met following an environmental monitoring failure.

    Product
    Endovascular AAA Pack, ESED52B; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3232-2024·2024-10-02

    Medical Device Kit Recall: Sterilization Assurance Cannot Be Confirmed

    American Contract Systems is recalling 60 Shoulder SESH18I medical convenience kits nationwide due to equipment failure that resulted in out-of-specification humidity readings, preventing sterilization assurance confirmation.

    Product
    Shoulder, SESH18I; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3240-2024·2024-10-02

    Surgical convenience kit sterilization assurance cannot be confirmed

    American Contract Systems is recalling the Essentia MAJ Laparotomy Std Pack because an equipment failure prevented confirmation of sterilization requirements for this medical convenience kit.

    Product
    Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3231-2024·2024-10-02

    Day Surgery General Pack medical kit recalled for sterilization concern

    American Contract Systems recalled 280 units of its Day Surgery General Pack due to humidity control failures that prevent confirmation of adequate sterilization.

    Product
    Day Surgery General Pack, FHGE18T; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3236-2024·2024-10-02

    Neuro Vascular Medical Kit Recalled for Sterilization Assurance Failure

    American Contract Systems recalls the Neuro Vascular ANKV91A medical convenience kit due to inability to confirm sterilization. Affected units were distributed across MO, MN, MA, OH, and NE.

    Product
    Neuro Vascular, ANKV91A; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2517-2024·2024-08-14

    American Contract Systems Hand Pack Convenience Kit Sterilization Failure

    American Contract Systems is recalling Hand Pack convenience kits that may not be sterile due to insufficient aeration time during sterilization. Affected devices distributed in CA, KS, ME, MN, MO, NE, and SD may pose a safety risk.

    Product
    American Contract Systems Hand Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2523-2024·2024-08-14

    Biopsy Drape Pack sterilization failure recall from American Contract Systems

    American Contract Systems is recalling 224 Biopsy Drape Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised the sterility of affected units. Lot 981241 distributed in CA, KS, ME, MN, MO, NE, and SD is affected.

    Product
    American Contract Systems Biopsy Drape Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2521-2024·2024-08-14

    Surgical Convenience Kits Recalled for Potential Sterilization Failure

    American Contract Systems is recalling three surgical convenience kits due to potential sterilization failure from insufficient aeration time during processing.

    Product
    American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2519-2024·2024-08-14

    American Contract Systems surgical kits recalled for sterilization defect

    American Contract Systems Laparoscopy and Lap Chole surgical kits are being recalled because insufficient aeration time after sterilization may have compromised their sterility. The kits were distributed in seven U.S. states.

    Product
    American Contract Systems Laparoscopy Litho Std Pack convenience kit and American Contract Systems Lap Chole convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2520-2024·2024-08-14

    Medical Procedure Kit Recalled Over Potential Sterilization Compromise

    American Contract Systems is recalling Special Procedure Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised sterility. Distributed in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.

    Product
    American Contract Systems Special Procedure Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2524-2024·2024-08-14

    American Contract Systems Spine Pack kits recalled for insufficient sterilization aeration

    American Contract Systems is recalling Spine Pack convenience kits (Lot 980241) due to incomplete post-sterilization aeration. The affected kits were distributed in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.

    Product
    American Contract Systems Spine Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2518-2024·2024-08-14

    Gyn Laparoscopy Kits Recalled Due to Inadequate Sterilization Process

    American Contract Systems is recalling 29 gynecological laparoscopy surgical kits due to insufficient aeration during sterilization, which may compromise sterility and increase infection risk for patients.

    Product
    American Contract Systems Gyn Laparoscopy convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2298-2024·2024-07-17

    Knee Arthroscopy Kit Recalled for Excessive Sterilant Chemical Residue

    American Contract Systems Inc is recalling 270 units of a knee arthroscopy surgical kit because sterilization chemical residues exceed safe limits for permanent device contact.

    Product
    KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2285-2024·2024-07-17

    Foot-Ankle Procedure Tray Recalled for Excessive Sterilization Residue

    American Contract Systems Inc is recalling 107 units of FOOT ANKLE-LF Procedure tray distributed nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits for permanent-implant devices.

    Product
    FOOT ANKLE-LF Procedure tray Catalog Number:CCFA51B
    Category
    Medical Device
    Distribution
    Distributed nationwide