The Recall Desk

Hazard

Ethylene Oxide Residue recalls

15 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
15
Critical
0
Severe
0
Most recent
2024-07-17

Of the 15 ethylene oxide residue recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all ethylene oxide residue recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–15 of 15

  • HighFDA (Devices)·Z-2305-2024·2024-07-17

    Hip Procedure Kit Recalled for Excessive Ethylene Oxide Sterilization Residuals

    American Contract Systems Inc is recalling 393 units of the TPK Anterior Hip Pack nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for permanent exposure medical devices.

    Product
    TPK ANTERIOR HIP PACK 176483-Procedure Kit Catalog Number: TPAH21E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2277-2024·2024-07-17

    Procedure Tray Recalled for Excess Ethylene Oxide Residue

    American Contract Systems is recalling a lower extremity procedure tray (48 units) due to ethylene oxide residuals that exceed FDA safety limits for permanent exposure medical devices.

    Product
    LOWER EXTREMITY - 247542- Procedure tray Catalog Number: BFLE56X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2312-2024·2024-07-17

    Knee Arthroscopy Kit Recalled for Elevated Sterilization Chemical Residues

    American Contract Systems Inc is recalling 60 units of the KNEE ARTHROSCOPY PACK-Procedure Kit nationwide due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component exceeding established safety limits.

    Product
    KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: WEKA15B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2297-2024·2024-07-17

    Total Knee Procedure Kit Recalled for Excess Ethylene Oxide Residue

    American Contract Systems Inc is recalling a knee surgery procedure kit (24 units, Lot 939241) due to ethylene oxide sterilization residues in the cast padding exceeding safety exposure limits for permanent-implant devices.

    Product
    TOTAL KNEE - 297835 -Procedure Kit Catalog Number: RGTK10L
    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-2291-2024·2024-07-17

    Knee Arthroscopy Pack Recalled for Excess Sterilization Residues

    American Contract Systems Inc. is recalling 84 knee arthroscopy packs (Catalog Number MEKA12R) distributed nationwide due to ethylene oxide and ethylene chlorohydrin residuals exceeding safe limits for permanent exposure medical devices.

    Product
    KNEE ARTHROSCOPY PACK Catalog Number: MEKA12R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2304-2024·2024-07-17

    Arthroscopy Procedure Kit Recalled Due to Ethylene Oxide Residue

    American Contract Systems Inc is recalling 27 arthroscopy procedure kits because ethylene oxide and ethylene chlorohydrin residuals in the cast padding exceeded safe exposure limits for permanent implants.

    Product
    ARTHROSCOPY PACK-Procedure Kit Catalog Number: TNAR22V
    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-2299-2024·2024-07-17

    TOTAL KNEE-Procedure Kit Recalled Due to Ethylene Oxide Residuals

    American Contract Systems is recalling 976 units of TOTAL KNEE-Procedure Kits nationwide due to ethylene oxide and ethylene chlorohydrin residuals in the cast padding component that exceed safe exposure limits for medical devices.

    Product
    TOTAL KNEE-Procedure Kit Catalog Number: SFTK54B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2283-2024·2024-07-17

    Orthopedic knee procedure tray recalled for sterilization residue levels

    American Contract Systems Inc is recalling 84 units of the ARTHRO KNEE BEACHES PACK BHS procedure tray because residual sterilization chemicals exceeded permissible exposure limits. The affected units were distributed nationwide.

    Product
    ARTHRO KNEE BEACHES PACK BHS- Procedure tray Catalog Number: BPKB46B
    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-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-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