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.

51–75 of 93

  • HighFDA (Devices)·Z-0524-2023·2022-12-21

    Stradis Healthcare Surgical Knee Packs Recalled for Incomplete Sealing

    HENRY SCHEIN Knee Packs are being recalled due to incomplete outer bag sealing that may breach sterility. Affected surgical kits were distributed in the US and Canada.

    Product
    HENRY SCHEIN, Knee Pack, Item No.570-2908,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0482-2023·2022-12-21

    Oral Surgery Tray Kit Recalled for Potential Sterility Breach

    ACE Surgical Supply oral surgery tray kits are recalled because the outer packaging may be incompletely sealed, potentially compromising sterility. The kits were distributed throughout the United States and Canada.

    Product
    ACE Surgical Supply, 17539 CUSTOM KIT STERILE Item No.003-3880, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0547-2023·2022-12-21

    Stradis Healthcare Medical Vein Kits Recalled for Potential Sterility Breach

    Stradis Healthcare is recalling Medical Vein procedure kits due to potentially incomplete sealing of the outer bag that may compromise kit sterility. No illnesses or injuries have been reported.

    Product
    STRADIS HEALTHCARE, Medical Vein, Item No.682-330,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0507-2023·2022-12-21

    Surgical Procedure Trays Recalled for Potential Sterility Breach

    Stradis Medical recalls Henry Schein Basin Pack surgical trays due to potentially incomplete outer packaging seals that may compromise sterility of the medical kits.

    Product
    HENRY SCHEIN, Basin Pack, Item No.570-1692
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2023·2022-12-21

    Surgical dental procedure kits recalled due to incomplete bag sealing

    Stradis Healthcare is recalling surgical and dental procedure kits due to manufacturing defects that may result in incomplete outer bag sealing and compromised sterility.

    Product
    STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2023·2022-12-21

    Surgical Procedure Kits Recalled by Stradis Healthcare for Sealing Defect

    Stradis Healthcare is recalling surgical procedure kits for perioral surgery due to a manufacturing defect that may result in incomplete outer bag sealing. This could compromise the sterility of the kits.

    Product
    STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0558-2023·2022-12-21

    Surgical Procedure Trays Recalled Due to Potentially Compromised Sterility

    Stradis Healthcare is recalling 75 units of surgical procedure trays because their outer bags may be incompletely sealed, potentially compromising sterility.

    Product
    STRADIS HEALTHCARE, TIP, SURGE-O-VAC .125" GREEN, Item No.SS077225,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0495-2023·2022-12-21

    Dental surgical kits recalled due to incomplete outer bag sealing

    Stradis Healthcare is recalling dental surgical procedure kits due to manufacturing issues that may result in incompletely sealed outer bags, potentially compromising kit sterility.

    Product
    STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0486-2023·2022-12-21

    STRADIS HEALTHCARE Oral Surgery Trays Recalled for Potential Sterility Breach

    Stradis Medical is recalling STRADIS HEALTHCARE oral surgery trays because the outer bag may be incompletely sealed, risking sterility compromise. No illnesses have been reported.

    Product
    STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0510-2023·2022-12-21

    Stradis Medical gynecological surgical kit recalled due to potential sterility breach

    Stradis Medical is recalling Henry Schein GYN Pack surgical kits with potentially incompletely sealed outer bags that may compromise sterility. The affected kits were distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, GYN PACK, Item No.570-2625
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0539-2023·2022-12-21

    Stradis Ablation Pack Recalled for Potentially Compromised Sterile Seal

    Stradis Healthcare is recalling Ablation Pack Item No. 682-130 due to incomplete outer bag seals that may compromise sterility. The defect may allow contamination of surgical kits.

    Product
    STRADIS HEALTHCARE, Ablation Pack, Item No.682-130,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0505-2023·2022-12-21

    Surgical Pain Tray Outer Bag May Not Be Properly Sealed

    Stradis Healthcare is recalling Henry Schein Surgical Pain Trays due to potential incomplete sealing of outer bags, which may compromise sterility. Healthcare providers and facilities should stop using affected trays and contact their supplier for replacement.

    Product
    HENRY SCHEIN, SURGICAL PAIN TRAY, Item No.570-1482
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0542-2023·2022-12-21

    Stradis Healthcare surgical procedure kits recalled for incomplete outer bag sealing

    Stradis Healthcare has recalled surgical procedure kits due to incomplete outer bag sealing that may compromise sterility. Affected units (40 units, lot 22235489419) were distributed across the United States and Canada.

    Product
    STRADIS HEALTHCARE, Surgery PK, Item No.682-1728,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0504-2023·2022-12-21

    Surgical Trays Recalled Due to Incomplete Bag Sealing

    Stradis Healthcare is recalling surgical trays due to incomplete outer bag sealing that may compromise sterility of the surgical kit.

    Product
    HENRY SCHEIN, Novasure Pack, Item No.570-1462, general surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0517-2023·2022-12-21

    Henry Schein Universal Tray Recall for Incomplete Sealing

    Stradis Medical recalls 675 Henry Schein Universal Trays due to incomplete outer bag sealing that may compromise sterility. The defect affects surgical procedures nationwide and in Canada.

    Product
    HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0540-2023·2022-12-21

    Surgical Procedure Trays with Potentially Compromised Sterile Packaging

    Stradis Healthcare is recalling surgical procedure trays due to potentially incomplete outer bag sealing that may compromise product sterility. Affected units were distributed nationwide in the US and Canada.

    Product
    STRADIS HEALTHCARE, Phleb, Item No.682-1425,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2023·2022-12-21

    Surgical procedure trays with incomplete outer bag seals recalled

    Stradis Healthcare is recalling Henry Schein labiaplasty procedure kits due to incomplete outer bag seals that could compromise sterility. The 42-unit recall affects products distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, Labiaplasty PackItem No.570-3118,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0516-2023·2022-12-21

    Stradis Healthcare Major Extremity Surgical Kits Recalled for Potential Sterility Breach

    Stradis Healthcare is recalling Henry Schein Major Extremity surgical kits due to incomplete outer bag sealing that could compromise kit sterility. Affected kits were distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0526-2023·2022-12-21

    Surgical procedure kit recalled due to incompletely sealed outer bag

    A HENRY SCHEIN extremity pack surgical kit is being recalled because its outer bag may not be completely sealed, which could compromise the sterility of the kit. Affected units were distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0550-2023·2022-12-21

    Stradis Healthcare Endo Pack Surgical Trays Recalled for Incomplete Seal

    Stradis Healthcare is recalling Endo Pack surgical trays (Item 682-509) because manufacturing defects may result in incompletely sealed outer bags, potentially compromising kit sterility. Products were distributed in the US and Canada.

    Product
    STRADIS HEALTHCARE, Endo Pack, Item No.682-509,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0487-2023·2022-12-21

    Oral Surgery Trays Recalled for Incomplete Sealing of Sterility Bags

    Stradis Healthcare is recalling certain oral surgery trays because the outer packaging may be incompletely sealed, potentially compromising the sterility of the surgical instruments.

    Product
    STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0521-2023·2022-12-21

    Medical and surgical procedure kits recalled for potential sterility loss

    Stradis Medical is recalling Henry Schein Basic Extended Pack procedure kits due to incomplete sealing of the outer bag, which may compromise sterility. Products were distributed in the US and Canada.

    Product
    HENRY SCHEIN, BASIC EXTENDED PACK, Item No.570-2890
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0548-2023·2022-12-21

    Stradis Healthcare Surgical Procedure Kits Recalled for Incomplete Sealing

    Stradis Medical recalls Vein & Laser surgical procedure kits due to incomplete outer bag sealing that may compromise sterility. The recall affects 10 units distributed in the US and Canada.

    Product
    STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0531-2023·2022-12-21

    Medical Surgical Trays and Kits Recalled for Incomplete Outer Bag Sealing

    Henry Schein Blue Tail Custom Pack surgical procedure trays are being recalled because manufacturing issues may have caused incomplete sealing of the outer bag, potentially compromising sterility.

    Product
    HENRY SCHEIN, Blue Tail Custom Pack, Item No.570-3091,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0553-2023·2022-12-21

    STRADIS HEALTHCARE Surgical Procedure Trays Recalled for Incomplete Sterile Sealing

    STRADIS HEALTHCARE surgical procedure trays and kits are being recalled due to a manufacturing condition that may result in incomplete sealing of the outer bag, potentially compromising kit sterility.

    Product
    STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142,
    Category
    Medical Device
    Distribution
    Distributed nationwide