The Recall Desk

Hazard

Uncleared Indication 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
1
Most recent
2026-04-01

Of the 2 uncleared indication recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (50%) 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 uncleared indication 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

  • ModerateFDA (Devices)·Z-1631-2026·2026-04-01

    BiDop 3 pocket Doppler labeling includes uncleared fetal indication

    Koven Technology is recalling the BiDop 3 Pocket Doppler packaged with a fetal probe because the product labeling includes a fetal indication for use that is not cleared under its 510(k).

    Product
    Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-held, battery-powered ultrasonic Doppler blood-flow detector
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0603-2014·2014-01-08

    Terumo Cardiovascular Procedure Kits Recalled Due to Uncleared Safety Valve

    Terumo is recalling 24,227 Custom Cardiovascular Procedure Kits because the Overpressure Safety Valve used in the arterial line was not cleared for that specific use.

    Product
    Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line
    Category
    Medical Device
    Distribution
    Distributed nationwide