The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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24026–24050 of 26082

  • HighFDA (Devices)·Z-0177-2022·2021-11-03

    Bivona Aire-Cuf Endotracheal Tubes Recalled for Compromised Sterile Barrier

    Smiths Medical is recalling 7136 Bivona Aire-Cuf Endotracheal Tubes due to inadequate pouch seals that compromise the sterile barrier. The issue affects specific lot numbers with 325mm shaft length.

    Product
    Bivona Aire-Cuf Endotracheal Tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0056-2022·2021-11-03

    Calcium Gluconate 10% Injectable Recalled for Sterility Assurance

    Red Mountain Compounding Pharmacy is recalling Calcium Gluconate 10% Injectable (PF) due to lack of assurance of sterility following an FDA inspection. The product was distributed to approximately 494 patients across seven states.

    Product
    CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Devices)·Z-0175-2022·2021-11-03

    Cliquid MD Software Version 3.4 May Provide Incorrect Analytical Results

    AB SCIEX's Cliquid MD version 3.4 software may incorrectly calculate Internal Standard concentrations when users hide or leave the IS column empty in customized LC-MS/MS tests, potentially leading to incorrect analytical conclusions.

    Product
    Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems. Model No. 5088288
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0051-2022·2021-11-03

    Vitamin B Complex Injectable Solution Recalled for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling Vitamin B Complex Injectable Solution (HP) due to lack of assurance of sterility raised during FDA inspection. Approximately 494 patients across seven states received affected prescriptions.

    Product
    VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Drugs)·D-0036-2022·2021-11-03

    Dexpanthenol Injection Solution Recalled for Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling Dexpanthenol 250mg/mL injection solution due to FDA findings that sterility assurance cannot be confirmed. The product was distributed to approximately 494 patients across seven states.

    Product
    DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Devices)·Z-0182-2022·2021-11-03

    Brachytherapy Planning Software Dose Calculation Discrepancy

    Elekta's Oncentra Brachy versions 4.0+ may calculate incorrect doses for two-channel ovoid applicators in certain circumstances. Approximately 1,072 devices distributed worldwide.

    Product
    Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0052-2022·2021-11-03

    Red Mountain Compounding Vitamin B Complex Injection Recall

    Red Mountain Compounding Pharmacy is recalling Vitamin B Complex Injection Solution because FDA inspection raised concerns about sterility assurance. Approximately 494 patients in seven states received the affected product.

    Product
    VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Devices)·Z-0001-2022·2021-11-03

    RAPTAR Laser Range Finders Recalled for Field Modification Safety Risk

    Potomac River Group recalls 62 RAPTAR Laser Range Finders (Model G02) nationwide. The devices can be field-modified to enable higher-power visible and infrared lasers, posing eye injury risk from uncontrolled laser radiation.

    Product
    RAPTAR Laser Range Finders
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0169-2022·2021-11-03

    GORE CARDIOFORM Septal Occluder devices labeled with incorrect expiration date

    W L Gore recalled 846 GORE CARDIOFORM Septal Occluder units labeled with a 3-year expiration instead of the correct 2-year expiration.

    Product
    REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0165-2022·2021-11-03

    GORE Cardioform Septal Occluder recalled for incorrect expiration date labeling

    W.L. Gore is recalling 138 units of GORE Cardioform Septal Occluder devices labeled with a 3-year expiration date instead of the actual 2-year shelf life.

    Product
    REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631018
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Drugs)·D-0062-2022·2021-11-03

    MIC Compounded Injection Recalled Due to Sterility Assurance Concerns

    Red Mountain Compounding Pharmacy is recalling MIC 25/50/50MG/ML MDV injectable medication due to lack of assurance of sterility following an FDA inspection. Approximately 494 patients in seven states received prescriptions for the affected product.

    Product
    MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Drugs)·D-0054-2022·2021-11-03

    Acetylcysteine 2% Ophthalmic Solution Recalled for Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling Acetylcysteine 2% Ophthalmic Solution due to lack of assurance of sterility. The FDA identified concerns during an inspection of the manufacturing facility.

    Product
    ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Devices)·Z-0181-2022·2021-11-03

    Siemens Advia Chemistry Urinary Protein Reagent Recall for Inaccurate Test Results

    Siemens is recalling Advia Chemistry Urinary/Cerebrospinal Fluid Protein reagent due to potential reagent carryover that may cause falsely depressed Hemoglobin A1c results, which could affect clinical decisions about patient treatment.

    Product
    Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0050-2022·2021-11-03

    Testosterone Ultra 250MG/ML Recalled for Sterility Assurance Concerns

    First Royal Care Co. LLC, operating as Red Mountain Compounding Pharmacy, is recalling Testosterone Ultra 250MG/ML in sesame oil due to lack of assurance of sterility identified during FDA inspection.

    Product
    TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Drugs)·D-0049-2022·2021-11-03

    Red Mountain Compounding Pharmacy Testosterone Blend Injection Sterility Recall

    Red Mountain Compounding Pharmacy is recalling a testosterone-blend injection product due to FDA concerns about sterility assurance. The product was distributed to patients in seven states.

    Product
    TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Devices)·Z-0173-2022·2021-11-03

    Medtronic recalls C315-HIS Delivery Catheters due to functional defect

    Medtronic is recalling 591 units of C315-HIS Delivery Catheters due to reports that a lead cannot pass through the catheter. The catheters were distributed internationally to multiple countries, and healthcare providers should contact Medtronic for guidance.

    Product
    C315-HIS Delivery Catheter
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0164-2022·2021-11-03

    Gore CARDIOFORM Septal Occluder recalled for incorrect expiration date

    W.L. Gore & Associates is recalling 2,238 GORE CARDIOFORM SEPTAL OCCLUDER 30 mm devices labeled with a 3-year expiration date instead of the actual 2-year expiration date.

    Product
    REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032
    Category
    Medical Device
    Distribution
    47 states
  • HighCPSC·22016·2021-11-03

    Usines Giant Factories Gas Water Heaters Recalled for Carbon Monoxide Risk

    Usines Giant Factories is recalling about 168 gas water heaters with Emerson control valves that can short circuit, overheat, and release carbon monoxide. The company will replace the control valve free of charge.

    Product
    Usines Giant Factories Gas Water Heaters with Emerson control valves
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0178-2022·2021-11-03

    Bivona Uncuffed Endotracheal Tubes Recalled for Compromised Sterile Barrier

    Smiths Medical ASD Inc. is recalling 2,191 Bivona Uncuffed Wire Endotracheal Tubes due to inadequate pouch seals that compromise the sterile barrier. Affected devices have 325mm shaft lengths and were distributed nationwide and internationally.

    Product
    Bivona Uncuffed Wire Endotracheal Tubes,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2022·2021-11-03

    BD Syringe Tip Cap Packaging Defect May Compromise Sterility

    Becton Dickinson & Company is recalling BD Syringe Tip Caps (Catalog Number 305822, Lot 1111347) due to holes in the packaging that may compromise sterility and container closure integrity.

    Product
    BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container closure integrity throughout the shelf life of the BD WWD syringe. Catalog Number: 305822
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0067-2022·2021-11-03

    Simple Mills Almond Flour Crackers Recalled for Undeclared Milk Allergen

    Simple Mills has recalled Almond Flour Crackers with fine ground sea salt because they contain undeclared milk allergen. The product was distributed across 36 states.

    Product
    Almond Flour Crackers fine ground sea salt packaged in a white box with yellow graphics weighing 4.25 oz. Label reads "***Simple Mills***Almond Flour crackers Fine Ground Sea Salt***Net wT 4.25 oz***" UPC: 856069005131
    Category
    Food
    Distribution
    37 states
  • HighFDA (Devices)·Z-0170-2022·2021-11-03

    GORE CARDIOFORM Septal Occluder Recalled for Incorrect Expiration Date Labeling

    W L Gore & Associates is recalling 187 units of GORE CARDIOFORM Septal Occluders because they are labeled with a 3-year expiration date instead of the correct 2-year expiration date. Using the device beyond its actual shelf life could compromise its safety and effectiveness.

    Product
    REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Drugs)·D-0045-2022·2021-11-03

    TEST CYP 25MG/ML Injectable Lacks Assurance of Sterility

    Red Mountain Compounding Pharmacy is recalling TEST CYP 25MG/ML in Ethyl Oleate because FDA inspection raised concerns about sterility assurance. Approximately 494 patients in seven states received prescriptions for this drug.

    Product
    TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Drugs)·D-0055-2022·2021-11-03

    Benzalkonium Chloride Solution Recalled Due to Sterility Concerns

    Red Mountain Compounding Pharmacy is recalling Benzalkonium Chloride 0.013% Solution due to lack of assurance of sterility identified during an FDA inspection. Approximately 494 patients in seven states received prescriptions for this product.

    Product
    BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states
  • HighFDA (Drugs)·D-0041-2022·2021-11-03

    Pyridoxine HCL Injection Recalled for Lack of Sterility Assurance

    Red Mountain Compounding Pharmacy is recalling pyridoxine HCL (vitamin B6) injectable solution due to lack of assured sterility. Approximately 494 patients in multiple states received affected prescriptions.

    Product
    PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx
    Category
    Drug
    Distribution
    7 states