The Recall Desk

Manufacturer

Stradis Medical, LLC dba Stradis Healthcare

93 recalls in our database name Stradis Medical, LLC dba Stradis Healthcare as the manufacturing or recalling firm.

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.

76–93 of 93

  • HighFDA (Devices)·Z-0554-2023·2022-12-21

    Angio Pack surgical trays recalled for incomplete sealing and sterility breach

    Stradis Healthcare is recalling Angio Pack surgical trays due to manufacturing defects that may leave the outer bag incompletely sealed, compromising product sterility. Affected units were distributed nationwide in the US and Canada.

    Product
    STRADIS HEALTHCARE, Angio Pack, Item No.686-199,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0536-2023·2022-12-21

    Stradis Healthcare Medical and Surgical Trays Recalled for Incomplete Bag Sealing

    Stradis Medical recalls medical and surgical procedure trays and kits due to incomplete outer bag sealing that may compromise sterility. Units were distributed nationwide in the US and Canada.

    Product
    STRADIS HEALTHCARE, Lipo, Item No.681-254,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0496-2023·2022-12-21

    Dental Procedure Trays Recalled for Incomplete Outer Bag Seal

    STRADIS HEALTHCARE dental procedure trays may have incompletely sealed outer bags that could compromise sterility. The recall affects units distributed nationwide in the US and Canada.

    Product
    STRADIS HEALTHCARE, Custom Pack, Item No.41213ATCP, dental
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1554-2022·2022-08-24

    Surgical forceps recalled due to potentially compromised sterile barrier

    Stradis Medical recalls 850 surgical forceps (NARMD MEDICAL DEPOT Forceps, part ZZ-0701) due to potentially compromised sterile barriers. Healthcare facilities with these units should identify affected lot numbers and contact the manufacturer for guidance.

    Product
    NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"; Part Number: ZZ-0701
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1553-2022·2022-08-24

    Surgical forceps recalled due to compromised sterile barrier

    Stradis Medical is recalling NARMD MEDICAL DEPOT Kelly Straight forceps because the sterile barrier may be compromised. The recall affects 825 units distributed nationwide in South Carolina.

    Product
    NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1552-2022·2022-08-24

    FDA Recalls Stradis Medical Surgical Scissors Due to Compromised Sterile Barrier

    Stradis Medical is recalling NARMD MEDICAL DEPOT Iris Curved Scissors (Part Number ZZ-0697) because the sterile barrier may be compromised, potentially exposing patients to contamination during surgical procedures.

    Product
    NARMD MEDICAL DEPOT Scissors Iris Curved 4.5", Part Number ZZ-0697
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0863-2022·2022-04-13

    Stradis Medical Anesthesia Kit Recalled Due to Sterility Breach Risk

    Stradis Medical is recalling Lum Lam Custom Pack Anesthesia Kits because the outer bag may be perforated or torn, potentially compromising the kit's sterility. Two lot numbers are affected.

    Product
    Lum Lam Custom Pack - Anesthesia Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0865-2022·2022-04-13

    Anterior Hip Surgical Kit Recall Due to Potential Sterility Breach

    Stradis Medical is recalling Anterior Hip Pack surgical kits due to perforated or torn outer bags that may compromise sterility. No illnesses have been reported.

    Product
    Anterior Hip Pack - Surgical Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0866-2022·2022-04-13

    Surgical kit recall due to outer bag perforation and sterility risk

    Stradis Medical is recalling 348 units of its Total Joint Pack Surgical Kit due to risk of outer bag tears or perforations that could compromise kit sterility. The recall affects units distributed in Indiana, Texas, and Pennsylvania.

    Product
    Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0862-2022·2022-04-13

    Neurological surgical kits may have compromised packaging sterility

    Stradis Medical is recalling Surgicare Neuro Pack neurological kits because the outer bag may be perforated or torn, potentially compromising product sterility. 176 units were distributed in Indiana, Texas, and Pennsylvania.

    Product
    Surgicare Neuro Pack - Neurological Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0864-2022·2022-04-13

    Total Knee Surgical Kit Recall Due to Potential Sterility Breach

    Stradis Medical is recalling 76 units of Total Knee Surgical Kits with potentially perforated or torn outer bags that may compromise sterility. Distribution occurred in Indiana, Texas, and Pennsylvania.

    Product
    Total Knee Pack - Surgical Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0131-2022·2021-10-27

    IUD Insertion Kit Recalled Over Manufacturing Standards Verification Issues

    Stradis Healthcare is recalling its Standard IUD Insertion Kit (280 units) after being unable to confirm the tenaculum devices meet required design and manufacturing standards.

    Product
    Standard IUD Insertion Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0126-2022·2021-10-27

    Plastic Tenaculum Surgical Instruments Recalled for Unconfirmed Manufacturing Standards

    Stradis Medical is recalling plastic tenaculum surgical instruments because the manufacturer cannot confirm they were produced in accordance with required design and manufacturing standards. Approximately 2,483 kits were distributed nationwide and to Canada.

    Product
    Tenaculum, Plastic
    Category
    Medical Device
    Distribution
    Distributed nationwide