The Recall Desk

Hazard

Missing Premarket Clearance recalls

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

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2021-08-18

Of the 1 missing premarket clearance 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 missing premarket clearance 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.

1–1 of 1

  • ModerateFDA (Devices)·Z-2227-2021·2021-08-18

    CIRRUS HD-OCT Model 6000 imaging devices recalled for missing FDA pre-market clearance

    Carl Zeiss Meditec is recalling 914 CIRRUS HD-OCT Model 6000 imaging devices. The manufacturer failed to obtain FDA pre-market clearance before selling the devices.

    Product
    Chassis Label - "CIRRUS HD-OCT Rx-Only" Product Label Exterior RX - "CIRRUS HD-OCT Model 6000"
    Category
    Medical Device
    Distribution
    53 states