The Recall Desk

Hazard

Labeling Non Compliance recalls

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

What the numbers show

Total
6
Critical
0
Severe
1
Most recent
2025-05-07

Of the 6 labeling non compliance 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 (17%) are Severe.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all labeling non compliance 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.

1–6 of 6

  • LowFDA (Devices)·Z-1694-2025·2025-05-07

    Defibtech Automated External Defibrillators Model DDU-2200 Missing Italian Translation

    Defibtech is recalling Automated External Defibrillators Model DDU-2200 distributed in Switzerland due to missing Italian translation of product labeling and instructions, which violates Swiss Medical Devices Ordinance requirements.

    Product
    Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual language)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0425-2023·2022-12-14

    FAST Sample Preparation System Labeling Corrected for Regulatory Scope

    Qvella is correcting documentation for the FAST System, a blood culture sample preparation device, because it exceeded its original regulatory scope. The company is updating manuals and promotional materials to clarify approved applications.

    Product
    The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for isolating bacterial cells directly from a positive blood culture (PBC). The cartridge and instrument isolate and concentrate bacterial cells directly from PBC
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1568-2022·2022-08-31

    Servo-air Ventilator Systems Lack Required Stability Warning Markings

    Getinge is recalling Servo-air Ventilator Systems because they lack required warning markings about stability risks when stationary. A total of 102 units were distributed in the US; 13,750 units were distributed internationally.

    Product
    Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1158-2022·2022-06-22

    Artri Ajo King Tablets Recalled for Unapproved Drug Claims

    Walmart is recalling all lots of Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets nationwide. The product was marketed without FDA approval based on unapproved labeling claims.

    Product
    Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets, ORIGINAL, 100-count bottles, UPC 7 501031 12705.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0507-2022·2022-01-26

    Heel Snuggler devices recalled for labeling changes without FDA approval

    Philips North America recalled approximately 2.5 million Heel Snuggler units because labeling was modified after FDA clearance without obtaining updated regulatory approval.

    Product
    Heel Snuggler, Reference # 989805603411 99047
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0910-2021·2021-08-25

    HiPP HA Infant Formula Recalled for Inadequate Iron and Missing Labeling

    Able Groupe Inc is recalling HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula (76,000 units) because some products contain less than the required iron per serving and lack mandatory FDA-compliant English labeling.

    Product
    HiPP HA Germany Hypoallergenic Stage PRE Combiotic Infant Milk Formula
    Category
    Food
    Distribution
    0 states