The Recall Desk

Hazard

Labeling Update recalls

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

What the numbers show

Total
27
Critical
23
Severe
0
Most recent
2025-10-29

Of the 27 labeling update recalls we have scored against our rubric, 23 (85%) 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 labeling update 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.

26–27 of 27

  • ModerateFDA (Devices)·Z-0041-2026·2025-10-15

    High flux dialyzers recalled to instruct users on newly redesigned press-on caps

    Fresenius Medical Care is issuing a recall covering Optiflux High Flux E-beam Dialyzers to tell users that the caps changed from threaded to press-on and must be pressed firmly to affix.

    Product
    Optiflux¿ High Flux E-beam Dialyzer Model Numbers: (1) 0500316E OPTIFLUX F160NRe 12/CS 1.5SA EBEAM, (2) 0500318E OPTIFLUX F180NRe 12/CS 1.7SA EBEAM, (3) 0500320E OPTIFLUX F200NRe 12/CS 1.9SA EBEAM, (4) 0500325E OPTIFLUX F250NRe 12/CS 2.5SA EBEAM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0036-2026·2025-10-08

    Vascular grafts recalled after delamination reports prompt instructions for use update

    W. L. Gore is recalling 52,306 GORE ACUSEAL Vascular Grafts following reports of graft delamination, and is updating the instructions for use with expanded warnings.

    Product
    GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.
    Category
    Medical Device
    Distribution
    51 states