The Recall Desk

Hazard

Unapproved Design Changes 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
2
Most recent
2026-04-29

Of the 2 unapproved design changes recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (100%) 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 unapproved design changes 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

  • SevereFDA (Devices)·Z-1886-2026·2026-04-29

    Medline Polycarbonate Syringes Recalled for Unapproved Design Changes

    Medline Industries is recalling select Convenience Kits containing 10mL polycarbonate colored syringes (Eye Pack and Heart Cath Pack) due to unapproved design changes made outside of FDA 510(k) clearance.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes EYE PACK DYNJ35056A HEART CATH PACK DYNJ69318A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1879-2026·2026-04-29

    Medline Convenience Kits with Syringes Recalled for Unapproved Design Changes

    Medline Industries, LP is recalling Medline Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed worldwide.

    Product
    Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes BIOPSY PACK DYNJ38587A, DYNJ38587B BIOPSY/DRAINAGE TRAY-LF DYNJ30078D W LINQ PACK DYNJ59108B
    Category
    Medical Device
    Distribution
    Distributed nationwide