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.

126–150 of 196

  • HighFDA (Devices)·Z-2311-2024·2024-07-17

    Hand Pack Procedure Kit recalled for excess ethylene oxide residuals

    American Contract Systems Inc is recalling the HAND PACK-Procedure Kit (catalog WEHD16C) due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits.

    Product
    HAND PACK-Procedure Kit Catalog Number: WEHD16C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2276-2024·2024-07-17

    American Contract Systems Surgical Trays Recalled for Ethylene Oxide Residuals

    American Contract Systems is recalling MAJOR KNEE surgical procedure trays due to excessive ethylene oxide and ethylene chlorohydrin residuals from sterilization that exceed safety limits for permanent exposure devices.

    Product
    MAJOR KNEE - 302497- Procedure tray Catalog Number: ASKN23B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2280-2024·2024-07-17

    Arthroscopy Procedure Tray Recalled for Excess Sterilization Residue

    American Contract Systems recalls the ARTHROSCOPY WOLFSON PACK BHS Procedure tray because ethylene oxide residuals on the cast padding exceeded safety limits for permanent exposure medical devices.

    Product
    ARTHROSCOPY WOLFSON PACK BHS Procedure tray Catalog Number: BPAR65A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2288-2024·2024-07-17

    Upper Extremity Cast Padding Recalled for Excessive Sterilization Gas Residuals

    American Contract Systems Inc. is recalling 192 units of cast padding due to excessive ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for skin-contact medical devices.

    Product
    UPPER EXTREMITY PK, STRL F G Catalog Number: IHUE40AG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2024·2024-07-17

    Procedure Kit Recalled for Excess Ethylene Oxide Residue in Cast Padding

    American Contract Systems Inc is recalling 36 units of Hand Pack procedure kits due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component exceeding regulatory limits.

    Product
    HAND PACK 297829--Procedure Kit Catalog Number: RGHN04I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2300-2024·2024-07-17

    Hand Draping Surgical Kit Recalled for Ethylene Oxide Residue

    American Contract Systems Inc is recalling the Hand Draping SJH-Procedure Kit because residual levels of ethylene oxide and ethylene chlorohydrin exceeded safe limits for permanent-contact medical devices.

    Product
    HAND DRAPING SJH-Procedure Kit Catalog Number: SJHD67F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2302-2024·2024-07-17

    Medical knee procedure kit recalled for excessive sterilization chemical residue

    American Contract Systems Inc is recalling TOTAL KNEE-Procedure Kits due to excessive ethylene oxide and ethylene chlorohydrin residues on the cast padding component. The recall affects 85 units distributed nationwide.

    Product
    TOTAL KNEE-Procedure Kit Catalog Number: SMTK21C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2310-2024·2024-07-17

    Hand Procedure Kit Recalled for Excess Ethylene Oxide Residuals

    American Contract Systems recalls HAND PACK-Procedure Kits due to excess ethylene oxide and ethylene chlorohydrin residuals on the cast padding component, exceeding safe permanent-contact exposure limits.

    Product
    HAND PACK-Procedure Kit Catalog Number: WEHD16B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2289-2024·2024-07-17

    Cast Padding Component Recalled for Excess Ethylene Oxide Residuals

    American Contract Systems Inc is recalling ACL cast padding components due to ethylene oxide/ethylene chlorohydrin residuals exceeding safe limits for permanent skin contact devices. Affected product distributed nationwide.

    Product
    ACL, ST LUKES METHODIST 1CS Catalog Number: LMAC10AA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2275-2024·2024-07-17

    Knee Procedure Tray Recalled for Excess Sterilization Gas Residue

    American Contract Systems is recalling TOTAL KNEE procedure trays because sterilization gas residuals on the cast padding component exceed regulatory safety limits. No injuries have been reported.

    Product
    TOTAL KNEE - 302497- Procedure tray Catalog Number: ANTK12AF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2293-2024·2024-07-17

    Total Knee Procedure Kit Recalled for Excess Sterilization Residuals

    American Contract Systems Inc recalls the TOTAL KNEE Procedure Kit due to Ethylene Oxide and Ethylene Chlorohydrin residuals exceeding regulatory limits. No illnesses reported.

    Product
    TOTAL KNEE -Procedure Kit Catalog Number: QPTK95A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2296-2024·2024-07-17

    Knee Surgery Procedure Kit Recalled for Ethylene Oxide Residue

    American Contract Systems Inc recalled a knee surgery procedure kit (Catalog RGTK10K) due to ethylene oxide and ethylene chlorohydrin residuals exceeding safety limits on the cast padding component.

    Product
    TOTAL KNEE - 297835-Procedure Kit Catalog Number: RGTK10K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0825-2024·2024-02-07

    Surgical Procedure Kits Recalled Due to Improper Sterilization

    American Contract Systems is recalling 7,881 surgical procedure kits nationwide because components were sterilized without proper validation, risking loss of functionality or elevated chemical residue.

    Product
    Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; b) BRACHY THERAPY PROCEDURE PAC, kit number AGBR90E; c) MINI MINOR AGH ASC PACK, kit number AGMM60M; d) OUTPATIENT PORT ACCESS KIT 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0823-2024·2024-02-07

    Urological procedural kits recalled due to sterilization defects

    American Contract Systems recalled 1,031 urological procedure kits nationwide due to sterilization process defects. Components may have damaged functionality, reduced drug efficacy, or elevated sterilization residuals.

    Product
    Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number HGUR87G; b) CYSTO PACK, kit number LVCY20; c) URO ROBOTIC PACK, kit number LVUR44;
    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-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-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-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 numbe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0827-2024·2024-02-07

    Custom Surgical Procedure Kits Recalled for Sterilization Assessment Failures

    American Contract Systems has recalled 2,717 custom surgical procedure kits used in neurosurgery nationwide. Components were added without proper assessment of their suitability for the sterilization process.

    Product
    Custom procedural convenience kits and trays, general hospital use, labeled as: a) IR NEURO PACK, kit number AGNE20J; b) ADULT CRANIOTOMY PACK, kit number LLCR99; c) LAMINECTOMY PACK, kit number LLLC26; d) KIT, CRANIOTOMY, kit number MMCR11J; e) KIT, NEURO SPINE, kit n
    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-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 number
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0826-2024·2024-02-07

    Custom Procedural Convenience Kits Recalled for Sterilization Validation Failure

    American Contract Systems is recalling 244 custom procedural kits (Baby PICC, Pediatric PICC, and PORT PACK) distributed nationwide. Components subjected to sterilization without proper validation documentation may have reduced functionality or elevated sterilization residuals.

    Product
    Custom procedural convenience kits and trays, general hospital use, labeled as: a) Baby PICC Kit, kit number UIBP90J; b) Baby PICC Kit, kit number UIBP90K; c) PORT PACK (PS 058330), kit number UIPO82AB; d) Pediatric PICC Kit, kit number UIPP76K;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0830-2024·2024-02-07

    Surgical kits for childbirth recalled for sterilization and functionality risks

    American Contract Systems is recalling C-section surgical kits that were sterilized without proper assessment. Components may have lost function or drug efficacy, or have excess sterilization residuals.

    Product
    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) C-SECTION PACK, kit number FDCS01AA; b) C-SECTION PACK, kit number FDCS01AB; c) C-SECTION STERILE PACK, kit number HGCS68J; d) C-SECTION PACK, kit number HICS50H; e) C-SECTION
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0821-2024·2024-02-07

    Gastroenterological and Urological Procedure Kits Recalled for Sterilization Process Failures

    American Contract Systems is recalling AHN BIOPSY STERILE procedure kits nationwide because several components were improperly sterilized, potentially compromising device functionality and drug efficacy.

    Product
    Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: AHN BIOPSY STERILE, kit number AHBP12A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0824-2024·2024-02-07

    Custom Surgical Convenience Kits May Lack Proper Sterilization Validation

    American Contract Systems, Inc. recalls surgical convenience kits whose added components may lack proper sterilization validation, potentially resulting in loss of functionality or retained sterilant residue.

    Product
    Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Plastics Pack, kit number BBPL20D; b) MINOR PLASTIC, kit number WPMP16H
    Category
    Medical Device
    Distribution
    Distributed nationwide