The Recall Desk

Hazard

Operational Risk 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
2021-08-11

Of the 2 operational risk 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 operational risk 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-2173-2021·2021-08-11

    Amia Automated PD System User Guide Incorrectly Describes Ultrafiltration Limit Function

    Baxter's user guide for the Amia Automated PD System incorrectly describes how the Ultrafiltration Limit setting controls the Extra Last Drain Mode. This documentation error could affect patients' ability to properly end therapy sessions.

    Product
    Sharesource Connectivity Platform for Use with the Amia Automated PD System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2016·2016-08-03

    Draeger Babytherm Infant Warmers Recalled for Skin Temperature Mode Risk

    Draeger Medical is recalling 1,599 Babytherm infant warmers due to a risk associated with operating the device in skin temperature mode without a patient connected.

    Product
    Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates a
    Category
    Medical Device
    Distribution
    Distributed nationwide