The Recall Desk

Hazard

Translation Error recalls

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

What the numbers show

Total
10
Critical
0
Severe
0
Most recent
2026-04-01

Of the 10 translation error 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 translation error 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.

1–10 of 10

  • HighFDA (Devices)·Z-1636-2026·2026-04-01

    Tandem insulin pump Czech guide inverted a key connection instruction

    Tandem Diabetes Care is recalling insulin pumps distributed in the Czech Republic and Slovakia because the Czech user guide contains translation errors, including one that inverts an infusion set instruction.

    Product
    Tandem pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current i
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0134-2025·2024-10-30

    Olympus Soltive Premium SuperPulsed Laser Recalled for Translation Labeling Error

    Olympus recalled 1,373 Soltive Premium SuperPulsed Lasers due to incorrect GUI translations of 'Bladder Stone' to 'Kidney Stone' in Spanish and Portuguese, potentially causing incorrect energy delivery to patients.

    Product
    Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, Model/Catalog Number: TFL-PLS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2106-2023·2023-07-12

    Ventilator Instructions for Use Contain Translation Error in Korean Materials

    Korean-language instructions for Trilogy Evo ventilators contain a mistranslation where 'invasive' was incorrectly rendered as 'noninvasive.' This error could lead to improper device configuration by Korean-speaking users.

    Product
    Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1421-2022·2022-07-27

    Medical Device Thawing Kit Recalls Due to Spanish Instruction Translation Error

    CooperSurgical recalls its LifeGlobal Fast Freeze Thawing Kit due to a Spanish instruction translation error that specifies 5 minutes instead of 5 seconds for blastocyte air thawing, affecting 403 units.

    Product
    LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-1102-2022·2022-05-25

    HeartWare HVAD Ventricular Assist Device Recalled for Translation Errors

    HeartWare is recalling 236 units of HVAD ventricular assist devices due to Finnish and Turkish translation errors in controller displays, instructions, and patient materials distributed in Finland and Turkey.

    Product
    HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1105-2022·2022-05-25

    HeartWare HVAD Controller: Translation Errors in Critical Documentation

    The FDA is recalling 59 units of HeartWare HVAD System Controller due to translation errors in Finnish and Turkish in device displays and critical documentation including patient manuals and emergency responder guides.

    Product
    HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1106-2022·2022-05-25

    HeartWare Ventricular Assist Device recalled for translation errors

    Heartware, Inc. is recalling the HeartWare Ventricular Assist Device (HVAD) in Finland and Turkey due to translation errors in device displays and supporting documentation that could impair proper device operation.

    Product
    HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1104-2022·2022-05-25

    HeartWare Ventricular Assist Device controller has translation errors in Finnish, Turkish

    HeartWare Ventricular Assist Device controllers in Finland and Turkey contain translation errors in displays, instructions, and patient manuals. The errors could affect proper device operation and emergency response.

    Product
    HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1107-2022·2022-05-25

    HeartWare HVAD Ventricular Assist Device Recalled for Translation Errors

    HeartWare is recalling 645 units of HVAD Ventricular Assist Device documentation due to translation errors in Finnish and Turkish. The errors affect controller displays, patient manuals, and emergency responder guides.

    Product
    HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Fin
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1103-2022·2022-05-25

    HeartWare HVAD System Controller Recalled for Translation Errors in Documentation

    Heartware is recalling 667 units of the HVAD System Controller (Model 1407DE Kit) due to translation errors in Finnish and Turkish in controller and monitor displays, as well as user documentation, which could affect patient understanding and emergency responder guidance.

    Product
    HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
    Category
    Medical Device
    Distribution
    0 states