The Recall Desk

Hazard

Incomplete Seal recalls

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

What the numbers show

Total
80
Critical
1
Severe
2
Most recent
2026-06-24

Of the 80 incomplete seal recalls we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (3%) are Severe.

Which agencies issued them

About this hazard tag

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

51–75 of 80

  • 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-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
  • 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-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-0528-2023·2022-12-21

    Medical Procedure Trays Recalled for Incomplete Outer Bag Sealing

    Stradis Healthcare recalls Henry Schein Rhino Pack surgical trays due to potentially incomplete outer bag sealing that may compromise kit sterility. The recall affects 328 units distributed in the US and Canada.

    Product
    HENRY SCHEIN, RHINO PACK, Item No.570-3070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0527-2023·2022-12-21

    HENRY SCHEIN Amnio Trays Recalled for Incomplete Outer Bag Seal

    HENRY SCHEIN Amnio Trays (Item No. 570-3059) manufactured by Stradis Medical are being recalled because the outer bag may be incompletely sealed, potentially compromising the sterility of the medical kit.

    Product
    HENRY SCHEIN, Amnio Tray, Item No.570-3059,
    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
  • 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-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-0498-2023·2022-12-21

    Stradis Healthcare Cotton Applicator 3 inch kits recalled due to incomplete bag sealing

    Stradis Healthcare is recalling cotton applicator 3 inch kits used in medical and surgical procedures due to incomplete outer bag sealing that may compromise kit sterility. Kits were distributed nationwide in the U.S. and Canada.

    Product
    STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0523-2023·2022-12-21

    Procedure Trays Recalled for Potential Sterility Breach Due to Incomplete Sealing

    Stradis Medical recalls Henry Schein procedure trays because the outer bag may be incompletely sealed, risking sterility breach. The trays were distributed nationwide and in Canada.

    Product
    HENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900,
    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-0502-2023·2022-12-21

    Breast Augmentation Trays Recalled Due to Incomplete Packaging Seal

    Stradis Medical recalls Henry Schein breast augmentation trays due to incomplete outer bag sealing during manufacturing, which may compromise sterility. The affected kits were distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, Breast Augmentation tray, Item No.570-0611
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0500-2023·2022-12-21

    Stradis Healthcare Introducer Kit Micro recalled for potential sterility compromise

    Stradis Healthcare is recalling 180 units of its Introducer Kit Micro cardiovascular devices due to potential incomplete sealing of outer bags that may compromise sterility.

    Product
    STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0552-2023·2022-12-21

    Surgical Procedure Kits Recalled for Incomplete Outer Bag Seal

    Stradis Healthcare is recalling Varicosity Basic Pack surgical procedure kits (105 units) distributed in the US and Canada due to potentially incomplete outer bag sealing that may compromise sterility.

    Product
    STRADIS HEALTHCARE, Varicosity Basic Pack, Item No.682-947,
    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-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-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-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-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-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-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-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-1688-2022·2022-09-14

    VYGON Dressing Change Kit Recalled for Potential Seal Integrity Issues

    Stradis Healthcare is recalling VYGON DRESSING CHANGE W/MAXISWAB kits due to potential incomplete seals that could compromise product sterility. Affected consumers should stop using recalled kits.

    Product
    VYGON DRESSING CHANGE W/MAXISWAB kit, REF AMS-8465CS
    Category
    Medical Device
    Distribution
    1 state