The Recall Desk

Hazard

Treatment Failure recalls

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

What the numbers show

Total
18
Critical
1
Severe
9
Most recent
2026-09-02

Of the 18 treatment failure recalls we have scored against our rubric, 1 (6%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (50%) 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 treatment failure 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.

1–18 of 18

  • SevereFDA (Drugs)·D-0778-2026·2026-09-02

    Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide

    Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium tablets because they may contain less active ingredient than labeled.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0707-2026·2026-07-29

    Levothyroxine Sodium Tablets Recalled for Subpotency

    Major Pharmaceuticals is recalling Levothyroxine Sodium Tablets, 25 mcg, due to subpotency. The recall affects nationwide U.S. distribution of specific lot numbers.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0706-2026·2026-07-29

    Major Pharmaceuticals Recalls Levothyroxine Sodium Tablets Over Subpotency

    Major Pharmaceuticals is recalling Levothyroxine Sodium Tablets, 150 mcg, lot N02167, due to subpotent drug concerns. The recall affects nationwide distribution in the USA.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2548-2026·2026-07-08

    Hillrom VOLARA System P.CIRCUIT KIT Medical Device Recall for Oxygen Drop Risk

    Baxter Healthcare is recalling the Hillrom VOLARA System P.CIRCUIT KIT (Model REF M08085) due to reports of air and medication leakage from the nebulizer cup, which can cause oxygen level drops and reduce treatment effectiveness.

    Product
    Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number REF M08085; Oscillation Lung Expansion Therapy, positive pressure breathing device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1603-2024·2024-05-01

    Proton Therapy System Recall: Safety Parameter Failures Risk Unintended Radiation

    IBA Proton Therapy System (PROTEUS 235) units recalled due to safety parameter failures that could prevent proper radiation control, risking unintended radiation exposure during cancer treatment.

    Product
    IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0153-2023·2022-11-09

    CritiCool Thermoregulation Device Recalled Due to Pump Failure

    The CritiCool thermoregulation device may experience premature pump failure leading to a HALT 4 error from which the device cannot recover, potentially delaying treatment. One death has been reported.

    Product
    CritiCool, thermoregulation device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0660-2022·2022-03-02

    Optima Coil System Recalled for Labeling and Packaging Mix-Up

    BALT USA recalls Optima Coil System embolization devices due to labeling/pouch mix-up that could result in incorrect device selection during surgical procedures. Potential harms include vessel damage and aneurysm rupture.

    Product
    The Optima Coil System consists of an implantable embolization coil comprised of a platinum-tungsten alloy attached to a proximal stainless steel hypo-tube and distal body coil delivery pusher with a radiopaque distal positioning marker and proximal fluorosafe marker. The Optima
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0761-2021·2021-01-06

    BD Phoenix PMIC-107 Recalled for False SXT Resistance Results

    Becton Dickinson is recalling BD Phoenix PMIC-107 IVDs because false resistant results for S. aureus could lead to reduced treatment effectiveness.

    Product
    BD Phoenix PMIC-107: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448417
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0766-2021·2021-01-06

    BD Phoenix PMIC-110 Recalled for False SXT Resistance Results

    Becton Dickinson & Co. is recalling BD Phoenix PMIC-110 IVDs due to false resistant SXT results with S. aureus, which could impact antibiotic treatment.

    Product
    BD Phoenix PMIC-110: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 449036:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0763-2021·2021-01-06

    BD Phoenix PMIC-108 Recalled for False SXT Resistance Results

    Becton Dickinson & Co. is recalling BD Phoenix PMIC-108 IVDs because false resistant results for S. aureus could lead to ineffective antibiotic treatment.

    Product
    BD Phoenix PMIC-108: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448418
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0764-2021·2021-01-06

    BD Phoenix PMIC/ID-109 Recalled for False SXT Resistance Results

    Becton Dickinson is recalling BD Phoenix PMIC/ID-109 because it may produce false resistant results for S. aureus, potentially affecting antibiotic treatment.

    Product
    BD Phoenix PMIC/ID-109: IVD is intended for the in vitro rapid identification (ID) of gram-positive bacteria from pure culture belonging to the genera Staphylococcus, Enterococcus, and other gram-positive cocci and gram-positive bacilli Catalog Number: 448609
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1402-2020·2020-03-04

    MicroVention HydroFrame 10 Embolic Coils Recalled for Missing Implant Coil

    MicroVention is recalling 991 HydroFrame 10 and HydroCoil embolic systems because the implant coil may be missing. The devices were distributed outside the United States.

    Product
    MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 100306HFRM-V, 100405HFRM-V, 100408HFRM-V, 100410HFRM-V, 100412HFRM-V, 100415HFRM-V, 100510HFRM-V, 100515HFRM-V, 100519HFRM-V, 100612HFRM-V, 100619HFRM-V, 100623HF
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1395-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention, Inc. is recalling 780 units of Microplex 10 Platinum Coil Systems because the implant coil may be missing from the device.

    Product
    MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206HCSR-S-V, 100208HC-S-V, 100208HCSR-S-V, 100306HCSR-S-V, 100308HCSR-S-V, 100310HC-S-V, 100310HCSR-S-V, 100410HC-S-V, 100410HCSR-S-V, Product
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1394-2020·2020-03-04

    MicroVention Platinum Coil System Recalled for Missing Implant Coil

    MicroVention is recalling 486 units of Microplex 10 Platinum Coil Systems because the implant coil may be missing from the device.

    Product
    MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Regular, Sterile, Rx, REF numbers 100515HC-R-V, 100515HCSR-R-V, 100520HC-R-V, 100520HCSR-R-V, 100620HC-R-V, 100620HCSR-R-V, 100730HC-R-V, 100730HCSR-R-V, 100830HC-R-V, 100930HC-R-V
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-1205-2019·2019-04-24

    Teva Recalls Subpotent Amoxicillin Oral Suspension Bottles Nationwide

    Teva Pharmaceuticals is recalling specific lots of Amoxicillin Oral Suspension because assay results were below specification limits. The affected bottles were distributed nationwide and in Puerto Rico.

    Product
    Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wale
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0161-2016·2015-11-04

    Pfizer Recalls Subpotent Xanax Alprazolam Tablets Nationwide

    Pfizer is voluntarily recalling 21,120 bottles of Xanax (alprazolam) 0.25 mg tablets because the medication contains less active ingredient than labeled.

    Product
    XANAX — XANAX (ALPRAZOLAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2198-2015·2015-07-29

    Philips Recalls GEMINI TF Base CT/PET Systems Due to Software Defects

    Philips is recalling two GEMINI TF Base CT/PET systems because four software defects in the Tumor LOC application may cause incorrect tissue irradiation.

    Product
    GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2194-2015·2015-07-29

    Philips Gemini LXL CT/PET Systems Recalled for Software Defects

    Philips is recalling two Gemini LXL CT/PET systems due to software defects that may cause incorrect radiation delivery to patients.

    Product
    GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide