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.

27476–27500 of 32222

  • SevereNHTSA·13V485000·2013-09-20

    New Flyer Recalls 2004-2006 D40I Buses Due to Fire Risk

    New Flyer is recalling 57 D40I transit buses from 2004-2006 because electrical components may conduct electricity and cause a fire.

    Product
    NEW FLYER — NEW FLYER D40I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V460000·2013-09-20

    Coach and Equipment Recalls 2009-2010 Metro-Lite and Phoenix Buses for Fire Risk

    Coach and Equipment is recalling 2009-2010 Metro-Lite and Phoenix buses equipped with optional power doors due to a potential circuit board overheating issue that could cause a vehicle fire.

    Product
    COACH & EQUIPMENT — COACH & EQUIPMENT PHOENIX, METRO-LITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V457000·2013-09-19

    North American Bus Industries Recalls Transit Buses Due to Fire Risk

    North American Bus Industries is recalling specific transit buses because a battery equalizer component may conduct electricity and cause a fire.

    Product
    OPTIMA — OPTIMA, NABI, BLUE BIRD OPUS, LFW, CLFW, BRT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V412000·2013-09-19

    Honda Recalls 2003-2004 Odyssey and 2003 Acura MDX for Air Bag Defect

    Honda is recalling 2003-2004 Odyssey and 2003 Acura MDX vehicles because electrical noise may cause air bags to deploy unexpectedly, increasing injury risk.

    Product
    ACURA — ACURA, HONDA MDX, ODYSSEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1010-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Vitamin D Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Vitamin D 50,000 I.U./ML Injectable due to FDA inspectional findings regarding sterility assurance and quality control.

    Product
    VITAMIN D 50,000 I.U./ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-962-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Compounded Sterile Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling compounded sterile injection solutions due to FDA inspectional findings regarding quality control and sterility assurance.

    Product
    GLUTATHIONE/LIDO 100MG/2%/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2181-2013·2013-09-18

    Monoject Heparin Lock Flush Syringes Recalled for Non-Sterile Water Contamination

    FDA is recalling Monoject 10 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water instead of the labeled saline or heparin solution.

    Product
    Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Product ID:8881580121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-960-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Compounded Glutamine Injection Solution

    Beacon Hill Medical Pharmacy is recalling compounded glutamine injection solution due to FDA inspectional findings regarding sterility assurance and quality control.

    Product
    GLUTAMINE 100 MG/ML INJ SOLN, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-999-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Sodium Hydroxide Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Sodium Hydroxide 10% Injection due to FDA inspectional findings regarding sterility assurance.

    Product
    SODIUM HYDROXIDE 10% (W/V)/WATER FOR INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1012-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Alprostadil Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Alprostadil 100 mcg/mL injection solution because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    ALPROSTADIL 100 MCG/ML INJ SOLN, all sizes, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-974-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Lipo-Plex Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Lipo-Plex Injectable because FDA inspections raised concerns about quality control procedures that impacted sterility assurance.

    Product
    LIPO-PLEX INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2129-2013·2013-09-18

    Siemens Microscan rapID/S panels recalled for false susceptibility results

    Siemens Healthcare Diagnostics is recalling Microscan rapID/S panels due to confirmed false susceptible and intermediate misreads for imipenem and meropenum.

    Product
    Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: MicroScan¿ Synergies plus¿ Panels & MicroScan¿ Rapids plus (Negative) - For use in determining quantitative and/or qualitative antimicrobial agent susceptibility and/or identification for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2182-2013·2013-09-18

    Monoject Heparin Lock Flush Syringes Recalled for Non-Sterile Water Contamination

    FDA is recalling Monoject Heparin Lock Flush syringes because they may contain non-sterile water instead of the labeled saline or heparin solution.

    Product
    Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Product ID: 8881580123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-984-2013·2013-09-18

    FDA Recalls Naltrexone Injectable Due to Sterility Assurance Concerns

    The FDA is recalling Naltrexone 1 mg/mL and 200 mg/mL injectables compounded by Beacon Hill Medical Pharmacy due to quality control issues affecting sterility assurance.

    Product
    NALTREXONE 1 MG/ML INJECTABLE and 200 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2179-2013·2013-09-18

    Monoject Flush Syringes Recalled for Potential Non-Sterile Water Contamination

    FDA is recalling Monoject 0.9% Sodium Chloride Flush Syringes because they may contain non-sterile water. The products are distributed in the US and Bermuda.

    Product
    Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Product ID: 8881570123 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-967-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Hydrogen Peroxide Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Hydrogen Peroxide 3% Injectable because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    HYDROGEN PEROXIDE 3% INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V455000·2013-09-18

    NOV Rolligon Recalls Trailers Due to Missing Suspension Weld

    NOV Rolligon is recalling specific 2011-2012 trailers because a missing weld on the rear suspension could cause the trailer to pull to one side or shift load, increasing crash risk.

    Product
    ROLLIGON — ROLLIGON MT-1060, HT-180, MT-1060-HR, HT-270
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1018-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Manganese Sulfate Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Manganese Sulfate 0.1 mg/mL Injectable due to FDA inspectional findings regarding sterility assurance.

    Product
    MANGANESE SULFATE 0.1 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-949-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Dextrose PF 50% Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Dextrose PF 50% Injectable because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    DEXTROSE PF 50% INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1005-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls TRI-MIX Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling TRI-MIX injection solutions because FDA inspectional findings raised concerns about sterility assurance and quality control.

    Product
    TRI-MIX 10 MCG/30 MG/1 MG/ML INJ SOLN and TRI-MIX 30 MCG/15 MG/2 MG/ML INJ SOLN, all configuration, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-972-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls L-Tryptophan Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling L-Tryptophan 300 mg/mL injectable due to FDA inspectional findings regarding sterility assurance.

    Product
    L-TRYPTOPHAN 300 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-989-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Potassium Chloride Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Potassium Chloride 2 mEq/mL Injectable because FDA inspectional findings raised concerns about sterility assurance and quality control procedures.

    Product
    POTASSIUM CHLORIDE 2 MEQ/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-973-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Lidocaine Injectable Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling Lidocaine MDV and Lidocaine PF injectables because FDA inspectional findings raised concerns about quality control procedures that impacted sterility assurance.

    Product
    LIDOCAINE MDV 1% INJECTABLE, LIDOCAINE MDV 20 MG/ML INJECTABLE and Lidocaine PF 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-987-2013·2013-09-18

    Beacon Hill Medical Pharmacy Recalls Parabens Water for Injection Due to Sterility Concerns

    Beacon Hill Medical Pharmacy is recalling all presentations of Parabens Water for Injection because FDA inspectional findings raised concerns about quality control procedures impacting sterility assurance.

    Product
    PARABEN WATER FOR INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI
    Category
    Drug
    Distribution
    Distributed nationwide