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.

1–25 of 93

  • HighFDA (Devices)·Z-0534-2023·2022-12-21

    Medical Insertion Tray Recalled for Incomplete Sterile Bag Sealing

    Stradis Medical is recalling Henry Schein ILR Insertion Trays due to incomplete outer bag sealing that may compromise sterility. No illnesses have been reported.

    Product
    HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0499-2023·2022-12-21

    Stradis Healthcare Safety Pins Recalled for Potential Sterility Breach

    Stradis Healthcare is recalling 1-inch safety pins due to manufacturing defects that may result in incomplete sealing of outer bags, potentially compromising the sterility of medical and surgical procedure kits.

    Product
    STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0491-2023·2022-12-21

    Stradis Healthcare Oral Surgery Trays Recalled Due to Incomplete Sealing

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

    Product
    STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0538-2023·2022-12-21

    Stradis Healthcare Thoracic Surgery Kits Recalled for Sterility Risk

    Thoracic Phleb procedure kits from Stradis Healthcare are being recalled due to incomplete outer bag sealing during manufacturing, which may compromise kit sterility.

    Product
    STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0545-2023·2022-12-21

    Stradis Healthcare Vein RF Pack surgical trays recalled for incomplete outer bag seal

    Stradis Healthcare is recalling 400 units of Vein RF Pack surgical trays due to manufacturing defects that may result in incomplete outer bag sealing, potentially compromising sterility.

    Product
    STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0529-2023·2022-12-21

    Surgical Procedure Kits Recalled Due to Incomplete Outer Bag Sealing

    Stradis Healthcare is recalling Henry Schein Custom PK 2 surgical procedure kits due to manufacturing defects that may result in incomplete outer bag sealing, potentially compromising sterility. The recall affects 27 units distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, CUSTOM PK 2, Item No.570-3072
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0497-2023·2022-12-21

    Dental Surgical Pack Recalled Due to Incomplete Sterile Seal

    Stradis Medical is recalling a dental surgical pack because the outer bag may be incompletely sealed, potentially compromising sterility. Affected units should not be used.

    Product
    Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0501-2023·2022-12-21

    Stradis Healthcare surgical procedure trays recalled for incomplete packaging seals

    Stradis Medical is recalling medical and surgical procedure trays with incomplete outer bag sealing, which may compromise sterility. The recall affects 150 units distributed nationwide in the US and Canada.

    Product
    STRADIS HEALTHCARE, PROBE COVER W/GEL PACK, Item No.525-071, general surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0481-2023·2022-12-21

    STRADIS HEALTHCARE Eye Surgical Kits Recalled for Incomplete Sealing

    STRADIS HEALTHCARE WECKCELL EYE SPEARS surgical kits (Item 9430, 9431) are recalled due to incomplete outer bag sealing that may compromise kit sterility. Approximately 80 kits distributed in the US and Canada are affected.

    Product
    STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0490-2023·2022-12-21

    Surgical Procedure Tray Recall Due to Incomplete Packaging Seal

    Stradis Healthcare is recalling oral surgery trays with potentially incompletely sealed packaging that may compromise sterility. No illnesses reported.

    Product
    STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0544-2023·2022-12-21

    Angioplasty Procedure Trays Recalled Due to Incomplete Bag Sealing

    Stradis Healthcare angioplasty procedure trays may have incompletely sealed outer bags, risking sterility compromise. Affected units should not be used pending further instructions.

    Product
    STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2023·2022-12-21

    Single-shot epidural kits recalled due to incomplete outer bag sealing

    Stradis Medical is recalling 80 Henry Schein single-shot epidural kits due to potentially incomplete outer bag sealing that could compromise sterility. The recall affects units distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0557-2023·2022-12-21

    Henry Schein Vas Reversal Pack Surgical Kit Recalled for Incomplete Seal

    A surgical procedure kit is being recalled due to manufacturing conditions that may result in an incompletely sealed outer bag, potentially compromising sterility. Affected kits were distributed in the US and Canada.

    Product
    HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0546-2023·2022-12-21

    Stradis Healthcare Venous Access Pack Recalled for Potential Sterility Breach

    Stradis Medical is recalling Venous Access Packs because the outer bag may be incompletely sealed, potentially compromising the sterility of the kit. Affected units were distributed in the US and Canada.

    Product
    STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0508-2023·2022-12-21

    Surgical Procedure Trays Recalled for Potential Sterility Breach

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

    Product
    HENRY SCHEIN, Basin Set, Item No.570-1803
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0522-2023·2022-12-21

    Surgical Procedure Trays Recalled for Incomplete Sterile Barrier Sealing

    Stradis Medical recalls Henry Schein surgical procedure trays due to incomplete outer bag sealing that may compromise sterility. No injuries reported.

    Product
    HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0512-2023·2022-12-21

    Medical and Surgical Procedure Trays Recalled for Incomplete Seal

    Stradis Medical recalled Henry Schein Basic Pack medical and surgical procedure trays due to manufacturing defects causing incomplete outer bag seals that may compromise sterility. The affected kits were distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0535-2023·2022-12-21

    Stradis Healthcare Curved Tip Syringes Recalled Due to Incomplete Sterile Sealing

    Stradis Medical is recalling approximately 300 Curved Tip Syringes because manufacturing defects may result in incomplete sealing of the sterile kit, potentially compromising product sterility.

    Product
    STRADIS HEALTHCARE, CURVED TIP SYRINGE, Item No.60060GCTS,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0556-2023·2022-12-21

    Surgical Procedure Trays Recalled Over Incomplete Outer Bag Seals

    Stradis Medical is recalling surgical procedure trays due to manufacturing defects that may leave outer bags incompletely sealed, potentially breaching kit sterility. No illnesses have been reported.

    Product
    HENRY SCHEIN, Vas Pack, Item No.888-2520,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0506-2023·2022-12-21

    General Surgery Procedure Kit Recalled for Sterility Concerns

    Stradis Medical is recalling surgical procedure kits with potentially incomplete outer bag seals that may compromise sterility. The recall affects 35 units distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0519-2023·2022-12-21

    Henry Schein Pacemaker Surgical Kits Recalled for Sterility Concerns

    Surgical procedure kits supplied by Henry Schein may have incompletely sealed outer bags, potentially compromising sterility. Affected units should not be used.

    Product
    HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0485-2023·2022-12-21

    Stradis Healthcare Surgical Pack Recall for Compromised Sterility

    Stradis Healthcare is recalling surgical kits because the outer bag may be incompletely sealed, potentially compromising the sterility of the product.

    Product
    STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0494-2023·2022-12-21

    Surgical Implant Trays Recalled for Incomplete Package Seal

    Stradis Healthcare is recalling 162 surgical implant trays distributed nationwide due to incomplete outer bag seals that may compromise sterility.

    Product
    Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0549-2023·2022-12-21

    Endovenous Procedure Packs Recalled for Incomplete Bag Sealing

    Stradis Healthcare is recalling Endovenous Packs due to incompletely sealed outer bags that may compromise kit sterility. No illnesses have been reported.

    Product
    www.StradisHealthcare.com, Endovenous Pack, Item No.682-494,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0509-2023·2022-12-21

    Surgical Procedure Kits Recalled for Potential Sterility Seal Defect

    Stradis Medical is recalling Henry Schein breast procedure kits distributed nationwide in the US and Canada due to incomplete outer bag sealing that may compromise sterility. No illnesses reported.

    Product
    HENRY SCHEIN, BREAST PACK, Item No.570-2397
    Category
    Medical Device
    Distribution
    Distributed nationwide