The Recall Desk

Archive

October 2024 recalls

601 recalls were announced in October 2024.

What the numbers show

Critical
4
Severe
86
High
449
Moderate
62

Of the 601 recalls this month scored against our rubric, 1% are Critical, 14% are Severe.

Which agencies issued them

401–500 of 601

  • HighFDA (Devices)·Z-3312-2024·2024-10-09

    Medical Display Unit Recalled for Unintended Touch Input During Patient Monitoring

    Philips DIVA 24-inch touch display may generate unintended touch inputs, risking erroneous acknowledgement of patient alarms and delayed detection of patient condition changes. No injuries have been reported.

    Product
    DIVA 24 Inch Widescreen LCD Touch Display - Used with the Philips PIC iX system central monitoring system. Model: RGD2461AMI Philips Part # 866126
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0003-2025·2024-10-09

    Spicy Murukku Snack Recalled for Undeclared Wheat Allergen

    Grace Imports is recalling Spicy Murukku snack due to undeclared wheat on the label. Consumers with wheat allergies face serious health risks from unlabeled exposure.

    Product
    SPICY MURUKKU INGREDIENTS: Rice Flour, Edible Veg Oil (Refined Palmolein Oil), Salt, Salt, Chilly powder, Roasted Bengal Gram Flour***Asafoetida, Natural Antioxidant (Mixed Tocopherol INS 305) ALLERGEN INFORMATION: Made in a Factory that Process Peanuts, Tree nuts, Soy, Milk, Wh
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0007-2025·2024-10-09

    Sqwincher Electrolyte Beverage Mix Recalled for Potential Metal Contamination

    Kent Precision Foods Group is recalling Sqwincher Electrolyte Beverage Mix in four flavors due to potential metal contamination. The affected powdered beverages were distributed across 11 states.

    Product
    1. Sqwincher Electrolyte Beverage Mix, orange powder packs, Net Wt 23.83 oz (1 lb 8 oz) 675.6 g: UPC 7588025004; packaged in assorted case, 32 per case / 2.5 gal yield item number 159016044 2. Sqwincher Electrolyte Beverage Mix, grape powder packs, Net Wt 23.83 oz (1 lb 8 oz) 67
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0013-2025·2024-10-09

    Big Bottom Milk Chocolate Milk Recalled for Inadequate Pasteurization

    Big Bottom Milk Company is recalling 701 units of Chocolate Milk Grade A (1-pint bottles) distributed in Georgia, North Carolina, and South Carolina due to failure to achieve required pasteurization temperatures.

    Product
    BIG BOTTOM MILK COMPANY, CHOCOLATE MILK GRADE A, 1 US Pint (0.473 liters), Big Bottom Milk Company 221 Hogan Rd, Forest City, NC, Expiration Date 09/09/2024 UPC code 850061506078
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0020-2025·2024-10-09

    Banana nut muffins recalled for undeclared milk and wheat allergens

    The Posh Bakery recalls Whole Grains Bakery Banana Nut Muffins (6 oz) due to undeclared milk and wheat allergens. The muffins lack required allergen-contains statements and nutritional fact labels.

    Product
    Whole Grains Bakery labeled "Banana Nut Muffin", 6 oz. Whole Grains Bon Croissant, Sacramento, CA 95826, (916)-793-0090 UPC"7 13583 05 101 6"
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0015-2025·2024-10-09

    Apple Cinnamon Muffins recalled for undeclared milk and wheat

    The Posh Bakery is recalling Apple Cinnamon Muffins due to undeclared milk (whey) and wheat flour. The product lacks a nutrition facts panel and allergen statement, posing a risk to consumers with allergies to these ingredients.

    Product
    Whole Grains Bakery labeled "Apple Cinnamon Muffin", 6 oz. Whole Grains Bon Croissant, Sacramento, CA 95826, (916)-793-0090 UPC "7 13583 05 109 2"
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0002-2025·2024-10-09

    Kerala Mixture Snack Recalled for Undeclared Wheat Allergen

    Grace Imports recalled Kerala Mixture snack due to undeclared wheat allergen. The supplier failed to disclose wheat on the product label, posing a risk to consumers with wheat allergies.

    Product
    KERALA MIXTURE INGREDIENTS: Gram Flour 48%, Edible Veg Oil (Refined Palmolein Oil) 36%, Peanuts 6%, Roasted Bengal Gram, Salt 1.5%, Chilly powder 1%, Curry leaf, Asafoetida, Natural Antioxidant (Mixed Tocopherol INS 305) ALLERGEN INFORMATION: Made in a Factory that Process Peanut
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0012-2025·2024-10-09

    Big Bottom Milk Company Chocolate Milk Recalled for Inadequate Pasteurization

    Big Bottom Milk Company is recalling chocolate milk that was not properly pasteurized. The recall affects 251 units distributed to Georgia, North Carolina, and South Carolina.

    Product
    BIG BOTTOM MILK COMPANY, CHOCOLATE MILK GRADE A, 1 US Half Gallon (1.89 liters), Big Bottom Milk Company 221 Hogan Rd, Forest City, NC, Expiration Date 09/09/2024 UPC code 850061506054
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0019-2025·2024-10-09

    Whole Grains Bakery Lemon Muffins Recalled for Undeclared Milk and Wheat

    The Posh Bakery is recalling Whole Grains Bakery Lemon Muffins (6 oz) due to undeclared milk and wheat allergens. The product lacks a nutrition facts panel and contains statement.

    Product
    Whole Grains Bakery labeled "Lemon Muffin", 6 oz. Whole Grains Bon Croissant, Sacramento, CA 95826, (916)-793-0090 UPC" 7 13583 05 106 1"
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0004-2025·2024-10-09

    Ceremonial Cacao Paste Recalled for Elevated Lead Levels

    Heart of the Earth ceremonial cacao paste is being recalled due to elevated lead levels in the product. Consumers should not consume this product and should contact a healthcare provider if they have concerns.

    Product
    Heart of the Earth (HOTE) 100% Pure Ceremonial Cacao Pre-Ground Paste. Net Wt. 16oz (454g). Packaged in Kraft paper heat sealed stand-up pouch bags with inner plastic liner with SKU PC-GRUCCP-1LB. Product of Guatemala. Distributed Soul Lift Cacao of Portland, Oregon. The produc
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-0021-2025·2024-10-09

    Carrot Muffins Recalled for Undeclared Milk, Wheat, and Coconut Allergens

    The Posh Bakery is recalling Carrot Muffins due to undeclared whey (milk), wheat flour, and coconut allergens, plus missing nutrition facts and allergen labeling. Consumers with allergies should not consume this product.

    Product
    Whole Grains Bakery labeled "Carrot Muffin", 6 oz. Whole Grains Bon Croissant, Sacramento, CA 95826, (916)-793-0090 UPC"7 13583 05 108 5"
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1836-2024·2024-10-09

    Mini Raspberry Lemon Coffee Cake Recalled for Undeclared Walnuts and Wheat

    Mini Raspberry Lemon Coffee Cake products in Washington were mislabeled and contain undeclared walnuts and wheat. Consumers with allergies to these ingredients should not consume the product and should return it to the store.

    Product
    Mini Raspberry Lemon Coffee Cake, net wt. 13.5oz. UPC 8 57297 00745 4. Made with Gluten-Free Ingredients in a Gluten-Friendly Bakery. Macrina Bakery - Kent, WA. Ingredients: CANE SUGAR, GREEK YOGURT (GRADE A PASTEURIZED CULTURED MILK, CREAM, NONFAT MILK), EGGS, RASPBERRIES, B
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0014-2025·2024-10-09

    Poppy Seed Muffins Recalled Due to Undeclared Milk, Wheat, and Almond Allergens

    The Posh Bakery is recalling 6-ounce Poppy Seed Muffins due to undeclared milk (whey), wheat, and almond allergens. The product lacks required allergen labeling, posing a risk to consumers with allergies.

    Product
    Whole Grains Bakery labeled "Poppy Seed Muffin", 6 oz. Whole Grains Bon Croissant, Sacramento, CA 95826, (916)-793-0090 UPC "7 13583 05 103 0"
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0011-2025·2024-10-09

    Big Bottom Chocolate Milk recall due to inadequate pasteurization

    Big Bottom Milk Company is recalling chocolate milk because required pasteurization temperatures were not achieved. Consumers should not consume this product.

    Product
    BIG BOTTOM MILK COMPANY, CHOCOLATE MILK GRADE A, 1 US Gallon (3.79 liters), Big Bottom Milk Company 221 Hogan Rd, Forest City, NC, Expiration Date 09/09/2024 UPC code 8 50061 50604 7
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0008-2025·2024-10-09

    Dental Ultrasonic Cleaner Recalled for Bacterial Contamination

    Young Dental Manufacturing is recalling BIOTROL PURIT Clean-It Ultrasonic Cleaner (REF PC016) due to bacterial contamination in the bulk product used for repackaging. The recall affects 1,391 units distributed across 10 states.

    Product
    BIOTROL PURIT Clean-It General Purpose Ultrasonic Cleaner, REF PC016, net contents 16 fl. oz., makes 16 gallons of solution.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-3303-2024·2024-10-09

    Urinalysis reagent strips recalled for reduced protein detection sensitivity

    Healgen Scientific is recalling 1,636,994 urinalysis test strips in California, Georgia, and Texas due to reduced protein detection sensitivity that may produce false negative results and delay kidney disease diagnosis.

    Product
    Healgen Series Reagent strips for Urinalysis are composed of several color pads aligned on a test strip. Each pad is employed for testing one assay item by visually or instrumentally reading the color change of the pad and comparing with the corresponding blocks on a color chart.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3313-2024·2024-10-09

    Alcon contact lenses recalled for manufacturing quality defect

    Alcon is recalling approximately 92,835 packs of contact lenses because a material quality issue may affect lens performance standards. Wearers may experience temporary eye irritation, redness, or blurred vision.

    Product
    DAILIES TOTAL1, DAILIES TOTAL1 for Astigmatism, DAILIES TOTAL1 Multifocal, TOTAL30 Sphere,
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-3311-2024·2024-10-09

    Contact lenses with misaligned axis may cause poor visual acuity

    CooperVision is recalling Biofinity Toric Multifocal soft contact lenses manufactured with misaligned axes resulting in incorrect optical power. Affected lenses may cause poor visual acuity.

    Product
    Biofinity Toric Multifocal Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3308-2024·2024-10-09

    DVOT Rapid Antigen Test Kits Recalled for Lack of FDA Authorization

    DVOT antigen test kits lack FDA authorization for US sale. Approximately 50,000 unauthorized kits were distributed. Users should discontinue use immediately due to unvalidated safety and accuracy.

    Product
    DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3310-2024·2024-10-09

    BIOFINITY XR TORIC Contact Lenses Recalled for Misaligned Axis Defect

    CooperVision is recalling 607 BIOFINITY XR TORIC soft contact lenses due to a manufacturing defect with misaligned axis, resulting in incorrect power and poor visual acuity. The lenses were distributed in the US and Canada.

    Product
    BIOFINITY XR TORIC Lenses - Soft Contact lenses Indicated for the correction of ametropia (myopia or hyperopia with astigmatism) with presbyopia in aphakic and non-aphakic persons.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3309-2024·2024-10-09

    Stryker Tornier Shoulder Implant Insert May Not Seat Securely

    Tornier Inc. is recalling 38 Stryker Tornier Perform Humeral System Reversed Inserts (model REF DWP2393) due to inverted locking rings. The defect may prevent the insert from seating securely in the implant stem or spacer.

    Product
    Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3305-2024·2024-10-09

    Atellica IM aTPO Assay Diagnostic Test Recalled for Measurement Bias

    Siemens Healthcare Diagnostics is recalling 9783 kits of the Atellica IM aTPO Assay diagnostic test due to positive bias in patient results below the 60 U/mL cut-off level, which may produce inaccurate test results.

    Product
    Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0007-2025·2024-10-09

    Philips IntelliVue G7m Anesthesia Gas Module Pump Failure

    Philips IntelliVue G7m Anesthesia Gas Modules may have a faulty sample gas pump that could stop working, interrupting gas measurement. Affected devices have serial numbers DE43800129 through DE43812627.

    Product
    IntelliVue G7m Anesthesia Gas Module, Product Number 866173
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0006-2025·2024-10-09

    Miami J Select Collar Recalled Due to Adhesive Failure

    Ossur is recalling Miami J Select Collars due to pressure-sensitive adhesive hooks that may peel off during repeated use, potentially reducing cervical spine immobilization effectiveness.

    Product
    Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
    Category
    Medical Device
    Distribution
    39 states
  • ModerateFDA (Drugs)·D-0002-2025·2024-10-09

    Ciclopirox Gel 0.77% Tubes Recalled Due to Broken Seals

    Glenmark Pharmaceuticals is recalling Ciclopirox Gel 0.77% tubes nationwide due to broken seals. The recall affects 11,568 tubes; no illnesses or injuries have been reported.

    Product
    Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gm Tube, NDC 68462-0455-47; c) 100 gm Tube, NDC 68462-0455-94, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513, India, Manufactured f
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0006-2025·2024-10-09

    Ryaltris Nasal Spray Recalled for Clogged Dip Tube

    Ryaltris nasal spray is being recalled because the dip tube is clogged, preventing the spray from functioning. The recall affects 45,504 bottles distributed nationwide.

    Product
    RYALTRIS — RYALTRIS (OLOPATADINE HYDROCHLORIDE AND MOMETASONE FUROATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3307-2024·2024-10-09

    DVOT SARS-CoV-2 and Influenza Antigen Test Kits lack FDA authorization

    The DVOT SARS-CoV-2 & Influenza A+B Antigen Combo Test Kit (Model FAT01) has not obtained FDA authorization for sale in the United States. All lots distributed in the U.S. are subject to recall.

    Product
    DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-3306-2024·2024-10-09

    DVOT SARS-CoV-2 Antigen Test Kit Recalled for Lack of FDA Authorization

    The DVOT SARS-CoV-2 Antigen Test Kit (Model FCY-AGT-01) manufactured by Feng Chun Yuan Medical Equipment has been recalled from the U.S. market because it was not authorized for sale in the United States.

    Product
    DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
    Category
    Medical Device
    Distribution
    0 states
  • HighUSDA FSIS·PHA-10082024-01·2024-10-08

    Cranberry Chicken Salad Products Recalled for Undeclared Wheat Allergen

    USDA FSIS issued a public health alert for Hans Kissle Cranberry Chicken Salad products that may contain undeclared wheat. Consumers with wheat allergies should not consume the product.

    Product
    Hans Kissle Company, LLC — FSIS Issues Public Health Alert for Ready-To-Eat Cranberry Chicken Salad Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·24V749000·2024-10-04

    Quality Van Recalls 2023 Ford Transit 350 for Seat Recliner Defect

    Quality Van is recalling one 2023 Ford Transit 350 because the seat recliner mechanism may not engage, increasing injury risk in a crash.

    Product
    QUALITY VAN — QUALITY VAN FORD TRANSIT 350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V740000·2024-10-03

    Terex Recalls 2023-2024 TL and TM Series Vehicles for Hydraulic Defect

    Terex is recalling 2023-2024 TL and TM series vehicles because a weak weld on the jib extension hydraulic cylinder rod may fail, increasing injury risk.

    Product
    TEREX — TEREX TM-SERIES, TL-SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V742000·2024-10-03

    2025 Winnebago Navion Motorhomes Recalled for Seat Belt Retractor Damage

    Winnebago Industries is recalling 2025 Navion and View motorhomes because a screw may damage the seat belt retractor. A damaged retractor may not secure occupants properly, increasing the risk of crash-related injury.

    Product
    WINNEBAGO — WINNEBAGO VIEW, NAVION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V745000·2024-10-03

    Honda Recalls 2023 CR-V Hybrid for Battery Module Defect

    Honda is recalling certain 2023 CR-V Hybrid vehicles due to incorrectly manufactured high-voltage battery modules that may break and spark, creating risks of fire and loss of drive power.

    Product
    HONDA — HONDA CR-V HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V744000·2024-10-03

    Steering Gearbox Assembly Defect in 2025 Honda Civic and Related Models

    Honda is recalling 1,693,199 vehicles across multiple model years due to a steering gearbox assembly manufacturing defect that can cause difficulty steering. Dealers will replace the component free of charge.

    Product
    HONDA — HONDA, ACURA CIVIC HYBRID, CIVIC HATCHBACK, CR-V, CIVIC HATCHBACK HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V743000·2024-10-03

    Altec Recalls 2024 AT200A Aerial Trucks Due to Hose Clearance Issue

    Altec is recalling 2024 AT200A aerial trucks because inadequate clearance between hydraulic hoses and the engine exhaust manifold may cause overheating and increase fire risk.

    Product
    ALTEC — ALTEC AT SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V747000·2024-10-03

    2025 INFINITI QX80 Rear Camera May Freeze in Reverse

    A software error may cause the rearview camera in 2025 INFINITI QX80 vehicles to freeze and display a blank screen when in reverse, reducing rear visibility and increasing crash risk. Dealers will reprogram the AVM software free of charge.

    Product
    INFINITI — INFINITI QX80
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V748000·2024-10-03

    2025 Nissan Rogue Rearview Camera May Fail Due to Software Error

    A software error may cause the rearview camera to display a blank screen in 2025 Nissan Rogue and related vehicles while in reverse, reducing driver visibility and increasing crash risk.

    Product
    NISSAN — NISSAN, INFINITI ROGUE, QX80
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V741000·2024-10-03

    2022-2024 Volvo VN Trucks Recalled for Unintended Acceleration Defect

    Volvo is recalling certain 2022-2024 VN trucks for a defect in the electronic control unit that can cause unintended acceleration. When the vehicle's communications system is interrupted, this may result in sudden acceleration increasing crash risk.

    Product
    VOLVO — VOLVO VN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3153-2024·2024-10-02

    Ivenix Infusion Pump Software Recalled for Potential Malfunctions

    Fresenius Kabi is recalling Ivenix Infusion System software (Version 5.9.1 and prior) due to anomalies that can cause pump malfunctions, alarms, or unresponsive screens while delivering medication, risking serious patient harm.

    Product
    Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V750000·2024-10-02

    School buses recalled for brake caliper mounting bolt defect

    Navistar is recalling 2024-2025 IC Bus school buses because brake caliper mounting bolts may not be properly tightened, allowing the brake caliper to detach and cause loss of braking ability. Owner notification was sent in November 2024.

    Product
    IC BUS — IC BUS EVSB, CESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3090-2024·2024-10-02

    ParaPAC Plus 310 ventilator connector may detach and stop ventilation

    Smiths Medical is recalling paraPAC Plus 310 ventilators because the patient outlet connector may loosen or detach, potentially interrupting ventilation. Approximately 11,244 units worldwide are affected.

    Product
    paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3091-2024·2024-10-02

    Smiths Medical Recalls paraPAC 300 Ventilator Kits Due to Connector Issue

    Smiths Medical is recalling 3,182 paraPAC 300 ventilator kits because the patient outlet connector may loosen or detach, impacting active ventilation.

    Product
    paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N
    Category
    Medical Device
    Distribution
    0 states
  • SevereNHTSA·24V738000·2024-10-02

    GM Recalls 2024-2025 Chevrolet Silverado HD Trucks for Inactive Air Bags

    General Motors is recalling certain 2024-2025 Chevrolet Silverado HD trucks because the air bag module may not have been activated, preventing deployment in a crash.

    Product
    CHEVROLET — CHEVROLET SILVERADO 5500, SILVERADO 6500, SILVERADO 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V739000·2024-10-02

    2024 BMW i7 M70 Integrated Brake Module Malfunction Affects Stopping and Control

    BMW is recalling certain 2024 i7 M70 and related models because the integrated brake module may malfunction, potentially reducing braking power and vehicle control. Dealers will replace the module at no cost.

    Product
    BMW — BMW 760I XDRIVE, 740I, 530I XDRIVE, I5 EDRIVE40
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3137-2024·2024-10-02

    CARDIOSAVE RESCUE intra-aortic balloon pump software correction for hemodynamic instability

    Datascope Corp. is issuing a software correction for CARDIOSAVE RESCUE intra-aortic balloon pump devices to address risks of hemodynamic instability and failure to properly transmit clinical data worldwide.

    Product
    CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3134-2024·2024-10-02

    Cardiosave hybrid IABP software defect poses hemodynamic instability and data loss risk

    Datascope's Cardiosave Hybrid IABP devices carry a risk of hemodynamic instability and clinical data transmission failure due to a software defect. Datascope has developed a software correction (Revision D.00) to mitigate this risk.

    Product
    CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3289-2024·2024-10-02

    Boston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Tip Detachment

    Boston Scientific is recalling Agile Esophageal Stent Systems because the delivery catheter tip may detach. The recall affects 17 units distributed worldwide.

    Product
    AGILE ESO OTW PC 23MM X 12.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3292-2024·2024-10-02

    Boston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Tip Detachment

    Boston Scientific is recalling Agile Esophageal Over the Wire Stent Systems because the delivery catheter tip may detach. The recall affects 19 units distributed worldwide.

    Product
    AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3135-2024·2024-10-02

    CARDIOSAVE Rescue IABP software defect poses hemodynamic instability risk

    Datascope CARDIOSAVE Rescue IABP devices have a software defect that risks hemodynamic instability and clinical data transmission failure. A software correction is available.

    Product
    CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3278-2024·2024-10-02

    FDA Recalls Esophageal Stent Systems Due to Delivery Catheter Tip Detachment Risk

    Boston Scientific recalled 364 esophageal stent systems due to potential delivery catheter tip detachment during placement procedures. No injuries have been reported. Affected patients and providers should contact the manufacturer.

    Product
    WALLFLEX ESOPHAGEAL FC 23/28MMX10CM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3204-2024·2024-10-02

    MRI Diagnostic Device Loose Screws May Block Patient Tabletop

    Philips SmartPath dStream MRI devices have loose screws in the RF carrier assembly that may interfere with the moving tabletop, potentially delaying diagnosis. Affected units should be inspected and repaired immediately.

    Product
    SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782113; 2) 781270; 3) 782129
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V737000·2024-10-02

    2025 Chevrolet Equinox EV door strikers recalled for possible breakage

    General Motors is recalling 2025 Chevrolet Equinox EV vehicles (along with Blazer and Blazer EV models) because door strikers may not be properly heat-treated and could break, causing doors to open unexpectedly. All affected vehicles remain in dealerships.

    Product
    CHEVROLET — CHEVROLET BLAZER EV, EQUINOX EV, BLAZER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3269-2024·2024-10-02

    Boston Scientific Recalls WallFlex Esophageal Stent Systems Due to Catheter Tip Detachment

    Boston Scientific is recalling WallFlex and Agile esophageal stent systems because the delivery catheter tip may detach. The recall covers 176 units distributed worldwide.

    Product
    WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esoph
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3230-2024·2024-10-02

    American Contract Systems Recalls Open Shoulder Medical Convenience Kits

    American Contract Systems is recalling 12 Open Shoulder medical convenience kits because a faulty chart recorder prevented verification of sterilization requirements.

    Product
    Open Shoulder, LWOS39L; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3281-2024·2024-10-02

    Boston Scientific Recalls WallFlex Esophageal Stents Due to Catheter Tip Detachment

    Boston Scientific is recalling WallFlex and Agile esophageal stent systems because the delivery catheter tip may detach during use.

    Product
    WALLFLEX PC ESOPH STENT 18/23MM X 103MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3294-2024·2024-10-02

    Boston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Tip Detachment

    Boston Scientific is recalling Agile Esophageal Stent Systems because the delivery catheter tip may detach. The recall affects 10 units distributed worldwide.

    Product
    AGILE ESO FC RMV 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3301-2024·2024-10-02

    Cardinal Health Recalls Salem Sump Stomach Tubes Due to Valve Breakage

    Cardinal Health is recalling Salem Sump Dual Lumen Stomach Tubes because the Anti-Reflux Valve may break due to improper use. Labeling changes were made to address the issue.

    Product
    (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8888264945, Sterile; (c) CardinalHealth Salem Sump Dua
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3288-2024·2024-10-02

    Boston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Detachment Risk

    Boston Scientific is recalling Agile Esophageal Stent Systems because the delivery catheter tip may detach. The recall affects 15 units distributed worldwide.

    Product
    AGILE ESO OTW PC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3202-2024·2024-10-02

    Philips MR 7700 MRI Scanner Recall for Loose Screws

    Philips is recalling 7 MR 7700 MRI scanners because loose screws may block the tabletop, potentially delaying diagnosis or causing patient anxiety.

    Product
    MR 7700 -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782120
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3224-2024·2024-10-02

    Karl Storz Nephroscope Recall Due to Unapproved Reprocessing Instructions

    Karl Storz Endoscopy is recalling 5 nephroscopes because their instructions for use list reprocessing methods not reviewed or approved by the FDA.

    Product
    Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3243-2024·2024-10-02

    Medical device kit recalled due to inability to confirm sterilization assurance

    American Contract Systems recalled its Cysto medical convenience kit (36 units, Lot 2405033) due to a humidity monitoring failure that prevented confirmation of adequate product sterilization.

    Product
    Cysto, FTCY03L; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3080-2024·2024-10-02

    GE Giraffe Warmer Recalled for Incomplete Electrical Safety Testing

    Wipro GE Healthcare is recalling specific GE Giraffe Warmers because incomplete electrical safety testing during manufacturing may allow leakage current to exceed safety limits.

    Product
    GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition t
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3248-2024·2024-10-02

    Hologic Recalls Selenia Dimensions and 3Dimensions Breast Imaging Software

    Hologic is recalling Selenia Dimensions and 3Dimensions software due to a defect that may cause blurry images and potential misdiagnosis.

    Product
    Selenia Dimensions/ 3Dimensions-Digital breast tomosynthesis Software Version Dimensions 1.12.0 and 3Dimensions 2.3.0 system software as follows Model/Catalog Number: 1. ASY-16824 FMI UPGRADE KIT, DIMENSIONS 1.12.0.3 SYSTEM SOFTWARE UPGRADE FOR 1.11.1 SYSTEMS 2. ASY-16825 FMI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3221-2024·2024-10-02

    Medical endoscope recalled for unapproved sterilization instructions

    Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing methods that lack FDA review and approval.

    Product
    Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3277-2024·2024-10-02

    Boston Scientific Esophageal Stent Systems Recalled for Catheter Detachment Risk

    Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment. The recall affects 79 units distributed worldwide.

    Product
    WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3191-2024·2024-10-02

    Custom Procedure Kit Sheath Introducers Mislabeled by Size

    Merit Medical Systems is recalling Custom Procedure Kits (REF: K12T-11077) with 7F sheath introducers that are incorrectly labeled as 7.5F, a labeling discrepancy affecting 24 units distributed nationwide.

    Product
    Custom Procedure Kit, REF: K12T-11077
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1829-2024·2024-10-02

    M&P Food Vareniki Products Recalled for Undeclared Wheat

    M&P Food Productions is recalling Potato & Mushroom Vareniki because the products contain undeclared wheat, which poses a risk to consumers with wheat allergies.

    Product
    Potato & Mushroom Vareniki; M&P Food Production; NET WT. 14oz; HANDMADE; Keep Frozen; DOUGH INGREDIENTS: Flour, eggs, water, oil (soybean), salt; FILLING INGREDIENTS: Potato, Mushroom, Fried Onion; UPC: 707163026174
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1827-2024·2024-10-02

    Sour Cherry Vareniki Recalled for Undeclared Wheat Allergen

    M & P Food Productions is recalling Sour Cherry Vareniki frozen dumplings due to undeclared wheat, a major allergen not listed on the label.

    Product
    Sour Cherry Vareniki; M&P Food Production; NET WT. 14oz; HANDMADE; Keep Frozen; DOUGH INGREDIENTS: Flour, eggs, water, oil (soybean), salt; FILLING INGREDIENTS: Sour Cherry, Sugar; UPC: 707163026150
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-3236-2024·2024-10-02

    Neuro Vascular Medical Kit Recalled for Sterilization Assurance Failure

    American Contract Systems recalls the Neuro Vascular ANKV91A medical convenience kit due to inability to confirm sterilization. Affected units were distributed across MO, MN, MA, OH, and NE.

    Product
    Neuro Vascular, ANKV91A; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1824-2024·2024-10-02

    M&P Delicacies Pirozhki Pies Recalled for Undeclared Wheat and Milk

    M&P Delicacies Pirozhki (pies) are recalled due to undeclared wheat and milk in the product. Consumers with allergies to these ingredients should not consume the product.

    Product
    M&P Delicacies PIROZHKI (PIES) with Black Currant; INGREDIENTS: Flour, eggs, butter, vegetable oil, dry yeast, sugar, salt; Filling: Black currant, sugar, farina; 1 SERVING READY TO EAT; KEEP FROZEN
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-3270-2024·2024-10-02

    Wallflex and Agile Esophageal Stents Recalled for Catheter Tip Detachment Risk

    Boston Scientific recalls Wallflex FC and Agile Esophageal Stent Systems due to the potential for delivery catheter tip detachment during use. Approximately 145 units are affected worldwide.

    Product
    WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esoph
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3298-2024·2024-10-02

    Origio Sperm Wash Medium Recalled for Low Sodium Pyruvate Concentration

    CooperSurgical is recalling Origio Sperm Wash Medium due to low sodium pyruvate concentration. The deficiency could compromise gamete development in assisted reproductive procedures.

    Product
    Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3293-2024·2024-10-02

    Boston Scientific Agile Esophageal Over-the-Wire Stent System recalled for catheter tip detachment

    Boston Scientific is recalling the Agile Esophageal Over-the-Wire Stent System due to potential for delivery catheter tip detachment. Seven affected units distributed worldwide are identified by lot numbers 32889020 and 33178844.

    Product
    AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3240-2024·2024-10-02

    Surgical convenience kit sterilization assurance cannot be confirmed

    American Contract Systems is recalling the Essentia MAJ Laparotomy Std Pack because an equipment failure prevented confirmation of sterilization requirements for this medical convenience kit.

    Product
    Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3284-2024·2024-10-02

    Esophageal Stent Systems Recalled Due to Catheter Detachment Risk

    Boston Scientific is recalling Wallflex and Agile esophageal stent systems worldwide due to the potential for delivery catheter tip detachment during placement. The recall affects 133 units distributed globally.

    Product
    WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3264-2024·2024-10-02

    Stryker TMJ Unilateral Implant Recalled Due to Incorrect Components

    TMJ Solutions Inc is recalling the Stryker TMJ Unilateral Implant because patient-fitted prostheses contained incorrect components. Patients should contact their healthcare provider immediately.

    Product
    Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Mandibular Component, Right.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3194-2024·2024-10-02

    Philips Ingenia 1.5T MRI Device Recall: Loose Screws May Block Tabletop

    Philips recalls certain Ingenia 1.5T MRI devices due to loose assembly screws that may block the patient tabletop, potentially delaying diagnosis and causing patient anxiety.

    Product
    Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782115 2) 782101 3) 782140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3276-2024·2024-10-02

    Boston Scientific Esophageal Stents Recalled for Delivery Catheter Tip Detachment

    Boston Scientific is recalling Wallflex and Agile Esophageal Stent Systems due to potential for delivery catheter tip detachment. The recall involves 124 units distributed worldwide.

    Product
    WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3247-2024·2024-10-02

    BD Phoenix diagnostic systems may misidentify E. coli in clinical samples

    The BD Phoenix 100 system may misidentify Escherichia coli in clinical samples, potentially leading to misdiagnosis and inappropriate patient treatment. Becton Dickinson is recalling 764 units distributed worldwide.

    Product
    BD Phoenix 100-Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number: 448100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3206-2024·2024-10-02

    BARD MAGNUM Biopsy Needles Recalled Due to Packaging Damage Risk

    Bard Peripheral Vascular is recalling BARD MAGNUM Disposable Core Tissue Biopsy Needles due to possible packaging damage from manufacturing that may compromise sterility.

    Product
    BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3187-2024·2024-10-02

    Roche Creatine Kinase test reagents recalled for calibration errors

    Roche Diagnostics is recalling Creatine Kinase test reagents that may exhibit abnormal calibrations, producing inaccurate results. Lot 755471 distributed nationwide.

    Product
    Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. Catalog Number: 07190794190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3203-2024·2024-10-02

    MRI Diagnostic Device Screws May Loosen, Block Tabletop

    Philips SmartPath to dStream 1.5T MRI devices may have loose assembly screws that could block the diagnostic tabletop and delay imaging. 32 units distributed worldwide.

    Product
    SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782112; 2) 781260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3246-2024·2024-10-02

    BD Phoenix M50 may misidentify E. coli bacteria in clinical samples

    The BD Phoenix M50 instruments may misidentify Escherichia coli (E. coli) in clinical samples, potentially causing misdiagnosis and inappropriate treatment. About 4,295 affected units were distributed worldwide.

    Product
    BD Phoenix M50 instrument -Intended for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically significant bacteria. The BD Phoenix System provides rapid results for most aerobic and facultative anaerobic Grampositive bacteria. Catalog Number:
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3262-2024·2024-10-02

    Airvo 3 Respiratory Device Recalled for Software Issue Affecting Oxygen Delivery

    Fisher & Paykel's Airvo 3 respiratory device has a software defect that may cause it to deliver only room air instead of oxygen during certain alarm conditions, potentially causing oxygen desaturation and hypoxia in patients.

    Product
    PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals and
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-3267-2024·2024-10-02

    Boston Scientific esophageal stents recalled due to catheter tip detachment risk

    Boston Scientific is recalling Wallflex and Agile esophageal stent systems due to potential detachment of the delivery catheter tip during stent placement. These devices are used to maintain patency in esophageal strictures caused by malignant tumors or esophageal fistulas.

    Product
    WALLFLEX FC ESO STENT RMV 18X153MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esopha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0668-2024·2024-10-02

    Prescription immunosuppressant tablets recalled due to failed dissolution specifications

    Ascend Laboratories recalled 117,493 bottles of Mycophenolic Acid tablets nationwide because the tablets failed to meet dissolution specifications. Patients taking this medication should consult their doctor.

    Product
    MYCOPHENOLIC ACID — MYCOPHENOLIC ACID (MYCOPHENOLIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3286-2024·2024-10-02

    WallFlex and Agile esophageal stent systems recalled for delivery catheter tip detachment

    Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential for delivery catheter tip detachment during insertion.

    Product
    WALLFLEX PC ESOPH STENT 23/28MM X 155MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3209-2024·2024-10-02

    Ultrasonic Cleaner Solution Recalled for Bacterial Contamination and Infection Risk

    Ultrasonic cleaner solutions contaminated with pathogenic bacteria may cause serious infections if used in medical or dental procedures, and may leak or become bloated. Patients and healthcare workers handling the products are at risk.

    Product
    Good Vibrations Ultrasonic Cleaner Solution, JorVet J0382G Ultrasonic Instrument Cleaning Solution, SpecClean Ultrasonic Cleaner Solution, Models: GVUS128-1, GVUS128-1EA, GVUS550-1, GVUS24-1, GVUS24-1EA, JGVUS128-1, VGVUSNP128-1, VGVUSNP128-1EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3217-2024·2024-10-02

    Siemens Diagnostic Ultrasound Systems Recalled for Incorrect Unit Conversion

    Siemens ACUSON Maple ultrasound systems may perform incorrect unit conversion in software, producing values 10 times smaller than actual. This could lead to misdiagnosis or inappropriate patient management.

    Product
    ACUSON Maple 1.0 Diagnostic Ultrasound System, REF: 11711750, with software. ACUSON Maple Select 1.0 Diagnostic Ultrasound System, REF: 11711779, with software
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-3226-2024·2024-10-02

    Medical Pacemaker Pack Recalled Due to Sterilization Assurance Failure

    American Contract Systems is recalling the PACEMAKER PACK (Lot 2405112) due to an inoperable chart recorder that prevented confirmation of sterilization requirements. Affected units were distributed in MO, MN, MA, OH, and NE.

    Product
    PACEMAKER PACK, SLCV01J; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3199-2024·2024-10-02

    MRI Diagnostic Device Recalled for Loose Assembly Screws Blocking Equipment

    Philips Ingenia Elition S MRI machines (10 units) are recalled because assembly screws may come loose and interfere with the horizontal tabletop, potentially delaying diagnosis and causing patient anxiety.

    Product
    Ingenia Elition S -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782150 2) 782106
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3238-2024·2024-10-02

    Vaginal Delivery Medical Convenience Kit Recalled for Unconfirmed Sterilization Assurance

    American Contract Systems, Inc. is recalling the Vaginal Delivery ASDV25B medical convenience kit due to an inoperable chart recorder that prevented confirmation of sterilization assurance. The device may not meet required sterilization standards.

    Product
    Vaginal Delivery, ASDV25B; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3244-2024·2024-10-02

    Pacemaker COPM11B Medical Kits Recalled for Sterilization Verification Issue

    American Contract Systems is recalling 3 units of the COPM11B pacemaker medical kits due to inability to confirm sterilization requirements were met. An inoperable chart recorder caused humidity readings to exceed specifications during manufacturing.

    Product
    Pacemaker, COPM11B; Medical convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3266-2024·2024-10-02

    WallFlex and Agile Esophageal Stent Systems Recalled for Catheter Tip Detachment

    Boston Scientific recalls WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The affected stents treat esophageal strictures and may cause procedural complications if detachment occurs.

    Product
    WALLFLEX FC ESO STENT RMV 18X123MM-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esopha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0663-2024·2024-10-02

    Pyridoxine Injection Solution Recalled Due to Lack of Sterility Assurance

    Empower Pharmacy is recalling a pyridoxine (B6) injection solution because sterility assurance could not be confirmed. The recalled product is lot 609763 with a beyond-use date of 04/18/2025.

    Product
    Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3251-2024·2024-10-02

    Cook Biotech Fistula Plug recalled for expiring before labeled date

    Cook Biotech is recalling 3 units of Biodesign Fistula Plug surgical implants because they expire before the printed expiration date. The devices were distributed worldwide.

    Product
    Biodesign Fistula Plug C-FPB-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G24668
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3259-2024·2024-10-02

    Biodesign Recto-Vaginal Fistula Plug units expire before labeled date

    Cook Biotech recalls Biodesign Recto-Vaginal Fistula Plug RVP-0.4 units because they expire before their labeled expiration dates. Affected lots were distributed worldwide.

    Product
    Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3273-2024·2024-10-02

    Wallflex and Agile Esophageal Stent Systems Recalled Due to Catheter Tip Detachment Risk

    Boston Scientific is recalling the Wallflex Esophageal Stent System and Agile Esophageal Over the Wire Stent System due to potential delivery catheter tip detachment during placement. Wallflex devices totaling 115 units are affected.

    Product
    WALLFLEX FC ESO STENT RMV LL 23X125-Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esoph
    Category
    Medical Device
    Distribution
    Distributed nationwide

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