The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

28476–28500 of 32252

  • SevereFDA (Drugs)·D-271-2013·2013-05-01

    Methylprednisolone Acetate Injectable Recalled for Sterility Assurance Concerns

    Axium Healthcare Pharmacy is recalling Methylprednisolone Acetate injectable vials due to lack of sterility assurance and quality control concerns.

    Product
    Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-291-2013·2013-05-01

    Axium Healthcare Recalls Triamcinolone Acetonide Injectable Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Triamcinolone Acetonide Injectable due to a lack of assurance of sterility and quality control concerns.

    Product
    Triamcinolone Acetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-278-2013·2013-05-01

    FDA Recalls Cyclosporin Ophthalmic Vials Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Cyclosporin (Grapeseed Oil) Ophthalmic vials due to a lack of assurance of sterility and quality control concerns.

    Product
    Cyclosporin (Grapeseed Oil) Ophthalmic Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-279-2013·2013-05-01

    Phosphatidylcholine Injectable Recalled for Lack of Sterility Assurance

    Axium Healthcare Pharmacy is recalling Phosphatidylcholine Injectable due to lack of sterility assurance and quality control concerns.

    Product
    Phosphatidylcholine Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-294-2013·2013-05-01

    BiMix Customs Injectable Recalled for Lack of Sterility Assurance

    Axium Healthcare Pharmacy is recalling BiMix Customs Injectable due to lack of sterility assurance and quality control concerns.

    Product
    BiMix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-289-2013·2013-05-01

    Axium Healthcare Recalls Bacteriostatic Water for Injection Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling all lots of Bacteriostatic Water for Injection 0.9% due to lack of sterility assurance and quality control concerns.

    Product
    Bacteriostatic Water for Injection 0.9% Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-270-2013·2013-05-01

    Axium Healthcare Recalls TriMix Injectable Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling TriMix Injectable vials due to lack of sterility assurance and quality control concerns.

    Product
    TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-282-2013·2013-05-01

    Trimix Injectable Recalled by Axium Healthcare Pharmacy for Sterility Concerns

    Axium Healthcare Pharmacy is recalling Trimix injectable vials due to a lack of assurance of sterility and quality control concerns.

    Product
    Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-274-2013·2013-05-01

    Axium Healthcare Recalls Triamcinolone Hexacetonide Injectable Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling Triamcinolone Hexacetonide Injectable vials due to a lack of assurance of sterility and quality control concerns.

    Product
    Triamcinolone Hexacetonide Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-272-2013·2013-05-01

    Sodium Tetradecyl Sulfate Injectable Recalled for Sterility Assurance Concerns

    Axium Healthcare Pharmacy is recalling Sodium Tetradecyl Sulfate Injectable due to lack of sterility assurance and quality control concerns.

    Product
    Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereFDA (Drugs)·D-288-2013·2013-05-01

    Axium Healthcare Recalls DMSO Bladder Irrigation Solution Due to Sterility Concerns

    Axium Healthcare Pharmacy is recalling DMSO 50% Sterile Bladder Irrigation Solution because the company cannot ensure the product is sterile.

    Product
    DMSO 50% Sterile Bladder Irrigation Solution Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
    Category
    Drug
    Distribution
    4 states
  • SevereNHTSA·13V165000·2013-04-30

    Westmor Trailer Recall for Defective Pressure Relief Valves

    Westmor is recalling 2003-2013 trailers with specific Fisher pressure relief valves that may break and eject, posing injury and fire risks.

    Product
    WESTMOR — WESTMOR TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13E022000·2013-04-30

    Prevost Recalls Parking Brake Chambers Due to Fire Risk

    Prevost is recalling 416 parking brake chambers that may leak air, causing brakes to drag and overheat, which could result in a fire.

    Product
    PARKING BRAKE:CONVENTIONAL:AIR recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V166000·2013-04-29

    Mercedes-Benz Recalls 2013 GL Models for Seat Belt Anchor Bolt Defect

    Mercedes-Benz is recalling 2013 GL350, GL450, GL550, and GL63 vehicles because second-row seat belt anchor bolts may not be properly torqued, increasing injury risk in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GL63, GL350, GL450, GL550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V167000·2013-04-25

    HME Recalls 2011-2012 Fire Apparatus Due to Brake Dragging Risk

    HME is recalling 11 fire apparatus vehicles because parking brake chambers may leak, causing brakes to drag and overheat, which could result in a fire.

    Product
    HME — HME, FERRARA SPECTR FIRE APPARATUS, SPECTR, INTRUDER EMBER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V190000·2013-04-25

    Setra Recalls S417 TC and S407 Motorcoaches Due to Fire Risk

    Setra is recalling 2011-2013 S417 TC and 2012-2013 S407 motorcoaches because moisture in the engine compartment can cause electrical corrosion and potential fire.

    Product
    SETRA — SETRA S417 TC, S407
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1116-2013·2013-04-24

    Hospira GemStar Infusion Pump Recall for Potential Over-Infusion Risk

    Hospira is recalling GemStar infusion pumps because the motor may rotate backwards during low-rate infusions, potentially causing over-infusion of medication.

    Product
    The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1052-2013·2013-04-24

    Stryker Recalls ShapeMatch Cutting Guides Due to Internal Process Issues

    Stryker Orthopaedics is recalling ShapeMatch Cutting Guides used in knee surgeries due to potential issues with internal planning and production processes.

    Product
    ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1150-2013·2013-04-24

    Advanced Sterilization Products Recalls EVOTECH Endoscope Cleaner Due to Smoke Risk

    Advanced Sterilization Products is recalling 761 EVOTECH Endoscope Cleaner and Reprocessor systems because a circuit board malfunction can cause smoke to emanate from the device.

    Product
    EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V161000·2013-04-24

    Winnebago and Itasca Motorhomes Recalled for Missing Range Enclosure

    Winnebago is recalling 2012-2014 motorhomes because a missing range enclosure may allow propane gas to flow without a flame, creating a fire hazard.

    Product
    ITASCA — ITASCA, WINNEBAGO SUNCRUISER, MINNIE WINNIE, CAMBRIA, MERIDIAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1098-2013·2013-04-24

    Carefusion Recalls Alaris PC Units Due to Communication Errors

    Carefusion is recalling Alaris PC unit model 8015 with software version 9.12 due to communication errors when specific monitoring modules are attached.

    Product
    Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1126-2013·2013-04-24

    Accuray CyberKnife Iris Variable Aperture Collimator Recall for Beam Axis Shift

    Accuray Incorporated is recalling 176 Iris Variable Aperture Collimators for the CyberKnife System due to a defect that could shift the radiation beam's central axis.

    Product
    Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1128-2013·2013-04-24

    SR Instruments FG3105 Patient Scales Recalled Due to Load Cell Failures

    SR Instruments is recalling 806 FG3105 patient scales used with Joerns Healthcare lifters after two load cell failures caused patient falls.

    Product
    SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters. Model# FG3105 Patient Scales. Product Usage: The FG3105 Scale is designed for Joerns Healthcare for use in portable patient weighing systems. The scale is designed to be connected…
    Category
    Medical Device
    Distribution
    Distributed nationwide