The Recall Desk

Hazard

Documentation Inconsistency 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
2022-05-25

Of the 2 documentation inconsistency 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 documentation inconsistency 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-1110-2022·2022-05-25

    Documentation errors recalled in HeartWare HVAD instructions and manuals

    Medtronic is recalling instruction materials for the HeartWare HVAD ventricular assist device due to errors and inconsistencies in product documentation.

    Product
    Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are dist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1699-2021·2021-06-09

    NexSite HD hemodialysis catheter directions for use consistency recall

    MARVAO MEDICAL DEVICES is correcting the Directions for Use (DFU) for NexSite HD hemodialysis catheters to ensure consistency between field documentation and website information for 292 devices distributed in the U.S.

    Product
    NexSite HD, Hemodialysis Symmetric Tip Catheter for long term use
    Category
    Medical Device
    Distribution
    4 states