The Recall Desk

Hazard

Sterility Breach recalls

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

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility breach 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.

101–125 of 178

  • 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-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-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-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-0537-2023·2022-12-21

    Stradis Healthcare Phlebectomy Pack Recall Due to Sterility Breach Risk

    Stradis Healthcare recalls its Phlebectomy Pack (Item No. 682-001) due to incomplete sealing of outer bags, which may compromise sterility of surgical kits distributed nationwide.

    Product
    STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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
  • HighFDA (Devices)·Z-0514-2023·2022-12-21

    ENT Surgical Kits Recalled for Potential Sterility Loss

    Stradis Medical is recalling HENRY SCHEIN ENT surgical kits distributed nationwide due to defective outer bag sealing that may compromise sterility. Affected kits were distributed across the US and Canada.

    Product
    HENRY SCHEIN, ENT SET UP PACK, Item No.570-2742
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0513-2023·2022-12-21

    Medical and surgical procedure trays recalled for incomplete seal

    Stradis Medical recalls medical and surgical procedure trays due to manufacturing defects causing incomplete outer bag seals that may compromise kit sterility.

    Product
    HENRY SCHEIN, VEIN TRAY, Item No.570-2738,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0520-2023·2022-12-21

    Medical procedure trays recalled for incomplete outer bag sealing

    Stradis Medical recalls Henry Schein temp stimulator supplies due to incomplete outer bag sealing that may compromise kit sterility. Affected units should not be used until reviewed.

    Product
    HENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0532-2023·2022-12-21

    FDA recalls Henry Schein bone marrow kit for defective seal

    Henry Schein bone marrow kits may have incompletely sealed outer bags, compromising sterility. Affected units were distributed in the US and Canada.

    Product
    HENRY SCHEIN, BONE MARROW KIT, Item No.570-3092
    Category
    Medical Device
    Distribution
    Distributed nationwide