The Recall Desk

Hazard

Nonsterility recalls

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

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2021-09-15

Of the 2 nonsterility 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 nonsterility 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.

1–2 of 2

  • HighFDA (Devices)·Z-2441-2021·2021-09-15

    Guide Catheters Recalled for Potential Sterilization Defect

    Mivi Neuroscience is recalling 491 MIVI Super 90 Guide Catheters due to potential nonsterility from a pouch seal defect. The catheters are used to guide microcatheters in vascular procedures.

    Product
    MIVI Super 90 Guide Catheters, MIVI Mi-Axus 8F Catheters, REF MIA-9080S (80 cm length); MIA-9090S (90 cm length), and MIA-9095S (95 cm length), MIA-9080-E, MIA-9090S-E, MIA-9095S-E, Sterile. Device is used to facilitate the insertion and guidance of microcatheters into a selecte
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2442-2021·2021-09-15

    MIVI Super 90 8F Guide Catheter Recalled Due to Potential Sterility Defect

    Mivi Neuroscience is recalling MIVI Super 90 8F Guide Catheters (investigational sterile devices) due to a potential pouch seal defect that could compromise product sterility.

    Product
    MIVI Super 90 8F Guide Catheter, 95 cm, REF MIA-9095S-IDE, For Investigational Use Only; sterile, and Super 90 8F Guide Catheter, 90 cm, REF MIA-9090S-IDE, For Investigational Use Only. Device is used to facilitate the insertion and guidance of microcatheters into a selected blo
    Category
    Medical Device
    Distribution
    5 states