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.

What the numbers show

Total
93
Critical
0
Severe
0
Most recent
2022-12-21

Of the 93 recalls from Stradis Medical, LLC dba Stradis Healthcare 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 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-0515-2023·2022-12-21

    Medical and Surgical Procedure Trays Recalled Due to Incomplete Sealing

    Stradis Medical is recalling medical and surgical procedure kits with potentially incompletely sealed outer bags that may compromise sterility. Affected healthcare facilities should stop using these kits immediately.

    Product
    HENRY SCHEIN, OMFS, Item No.570-2779,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0518-2023·2022-12-21

    Medical Procedure Trays Recalled for Potential Sterility Breach

    Stradis Healthcare is recalling 100 units of Henry Schein CATH PACK kits due to manufacturing defects that may leave outer bags incompletely sealed, potentially compromising sterility.

    Product
    HENRY SCHEIN, CATH PACK Item No.570-2789
    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-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-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-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-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-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-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-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-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-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-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-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-0511-2023·2022-12-21

    Surgical Procedure Trays Recalled for Potential Sterile Barrier Compromise

    Stradis Medical is recalling 104 units of Henry Schein ENT surgical procedure trays due to incomplete sealing of the outer bag, which may compromise the sterility of the kit.

    Product
    HENRY SCHEIN, ENT PACK, Item No.570-2718
    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-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-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-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-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-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-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-0488-2023·2022-12-21

    Stradis Healthcare Oral Surgery Implant Packs Recalled for Incomplete Seal Defect

    Stradis Medical recalled 20 oral surgery implant packs with incomplete outer bag sealing that may compromise sterility. Affected lot numbers are 22228490663 and 22242491516, distributed in the US and Canada. No illnesses reported.

    Product
    STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray
    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-0543-2023·2022-12-21

    Surgical procedure trays recalled for incomplete outer-bag sealing

    Stradis Healthcare is recalling surgical procedure trays and kits due to manufacturing defects that may result in incomplete sealing of the outer bag, potentially compromising sterility. Affected products were distributed nationwide in the US and Canada.

    Product
    STRADIS HEALTHCARE, Vein, Item No.682-1732,
    Category
    Medical Device
    Distribution
    Distributed nationwide