The Recall Desk

Hazard

Sterile Seal Defect recalls

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

What the numbers show

Total
5
Critical
0
Severe
0
Most recent
2026-05-20

Of the 5 sterile seal defect recalls 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 hazard tag

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

1–5 of 5

  • HighFDA (Devices)·Z-2193-2026·2026-05-20

    Daig Livewire Steerable Electrophysiology Catheter Sterile Seal Defect Recall

    Stryker Sustainability Solutions is recalling three lots of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile packaging. The defect affects units distributed in the US, Israel, and Canada.

    Product
    Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0244-2023·2022-11-23

    Medtronic Visualase Cooled Laser Applicator Sterile Seal Defect Recall

    Medtronic is recalling 95 units of Visualase Cooled Laser Applicator System devices due to a defect in the outer pouch sterile seal. Affected devices were distributed nationwide to healthcare facilities.

    Product
    Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product. Used to necrotize or coagulate soft tissue by physicians in minimally invasive surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0816-2019·2019-02-13

    Angiotech Recalls Bone Marrow Needles Due to Sterile Seal Manufacturing Issue

    Angiotech is recalling 180 units of J Type Bone Marrow Needles due to a manufacturing issue affecting the sterile seal on blister trays.

    Product
    J Type Bone Marrow Needle 13ga x 6cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0819-2019·2019-02-13

    Bone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue

    Angiotech is recalling 2,502 bone marrow biopsy needles due to a manufacturing issue affecting the sterile seal on blister trays.

    Product
    Aguja para Biopsia Tipo Medula Osea Ergonomica 11ga x 10cm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0815-2019·2019-02-13

    Angiotech Recalls Bone Marrow Biopsy Needles Due to Sterile Seal Defect

    Angiotech is recalling 1,260 bone marrow biopsy needles due to a manufacturing issue affecting the sterile seal on blister trays.

    Product
    J Type Bone Marrow Needle 13ga x 10 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
    Category
    Medical Device
    Distribution
    Distributed nationwide