The Recall Desk

Archive

March 2023 recalls

1,013 recalls were announced in March 2023.

What the numbers show

Critical
68
Severe
432
High
400
Moderate
107
Low
6

Of the 1,013 recalls this month scored against our rubric, 7% are Critical, 43% are Severe.

601–700 of 1013

  • HighNHTSA·23V188000·2023-03-22

    Volvo Recalls 2023 Models for False Emergency Call System Warnings

    Volvo is recalling 2023 S60, C40, XC40, V60CC, XC60, and XC90 vehicles because a false warning may mask an actual emergency call system failure.

    Product
    VOLVO — VOLVO S60, C40BEV, XC40, V60CC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1262-2023·2023-03-22

    da Vinci Surgical System Patient Cart Ballscrew Failure Risk

    Intuitive Surgical recalls Patient Side Carts for da Vinci X and Xi surgical systems due to ballscrew failure risk. The failure could cause uncontrolled carriage movement leading to potential tissue injury during surgery. 9 units affected.

    Product
    Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X Surgical System, REF: IS4200; Patient Side Cart, REF: 380652, with instrument arms, used as part of the da Vinci Xi Surgical System, REF: IS4000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1255-2023·2023-03-22

    Medical Device Apheresis Kit Recalled Due to Stress Leak Risk

    Fenwal Inc is recalling 6,564 units in certain lots of Amicus apheresis kits because centrifuge packs may develop a stress leak. No illnesses or injuries have been reported.

    Product
    Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0601-2023·2023-03-22

    Café Intermezzo Strawberry Crème Torte Recalled for Undeclared Food Colorants

    Epic Baking is recalling 191 units of Café Intermezzo Strawberry Crème Torte due to undeclared synthetic food colorants in the buttercream. The product was distributed in Georgia and Tennessee.

    Product
    Cafe' Intermezzo Strawberry Cr¿me Torte 5.5 lbs Ingredients: White Cake, Water, Vegetable Oil, Strawberry Buttercream (Sugar, Shortening, Strawberry Jell-O, Vanilla Extract, Salt), Chocolate Pudding Mix, Strawberry Glaze, Red Chocolate Curls. Contains: Milk, eggs, wheat, and soy,
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1252-2023·2023-03-22

    BioFire Respiratory Panel 2.1 Recalled Due to Temperature Shipping Excursions

    BioFire Diagnostics is recalling BioFire Respiratory Panel 2.1 (RP2.1) diagnostic kits due to temperature excursions during shipping that may reduce device performance.

    Product
    In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0622-2023·2023-03-22

    Canton Dry Noodle Recalled for Peanut Contamination

    Baily International Foods is recalling Canton Dry Noodle products due to peanut contamination in a sub-ingredient. The affected products were distributed to wholesalers in 19 states for restaurant and institutional use.

    Product
    Canton Dry Noodle, packaged in 30lb. corrugated (cardboard) boxes.
    Category
    Food
    Distribution
    19 states
  • ModerateFDA (Food)·F-0600-2023·2023-03-22

    Red Velvet Torte Recalled for Undeclared Food Coloring

    Epic Baking's Cafe' Intermezzo Red Velvet Torte is recalled due to undeclared Red 40 food coloring. The recall affects 279 tortes distributed to Georgia and Tennessee.

    Product
    Cafe' Intermezzo Red Velvet Torte 5.5 lbs Ingredients: Red Velvet Cake, Water, Vegetable Oil, Cream Cheese Frosting (Cream Cheese, Sugar, Butter, Shortening, Vanilla Extract), Chocolate Pudding Mix. Contains: Milk, eggs, wheat, and soy, May contain tree nuts and peanuts.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0427-2023·2023-03-22

    White Chocolate Wafer Recalled for Undeclared Peanut Residue

    Clasen Quality Chocolate is recalling DF FT Simple Free White Wafer (Item #12935) due to undeclared peanut residue. Consumers with peanut allergies should avoid this product.

    Product
    DF FT Simple Free White Wafer (MB), Item # 12935. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Sugar, Palm Kernal Oil, Natural Flavor, Sunflower Lecithin (an emulsifier), and Salt. Distributed By: Clasen Quality Chocolate, 5126 West Terrace Drive, Madison, WI
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Food)·F-0585-2023·2023-03-22

    Cafe' Intermezzo apple crumb cheesecake recalled for incomplete ingredient labeling

    Epic Baking is recalling Cafe' Intermezzo apple crumb cheesecake (8 lbs) distributed to Georgia and Tennessee because the firm did not list sub-ingredients, though all major allergens are disclosed.

    Product
    Cafe' Intermezzo Apple Crumb Cheesecake 8 lbs Ingredients: Eggs, Cream Cheese, Sugar, Apple Saute (Applesauce, Brown Sugar, Butter, Cinnamon, Lemon Juice, Vanilla Extract, Nutmeg). Cream Cheese Frosting (Cream Cheese, Sugar, Butter, Shortening, Vanilla Extract). Apple Crumb Topp
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0430-2023·2023-03-22

    Semisweet Chocolate Drops Recalled for Undeclared Peanut Residue

    Clasen Quality Chocolater recalls 1M Simply Free Semisweet Chocolate Drops due to potential undeclared peanut residue. Consumers with peanut allergies should not consume this product.

    Product
    1M Simply Free Semisweet Chocolate Drop (FT), Item # 53384. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Sugar, Chocolate Liquor, Cocoa Butter, Sunflower Lecithin (an emulsifier), and Vanilla Extract. Distributed By: Clasen Quality Chocolate, 5126 West Terrace
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1253-2023·2023-03-22

    In Vitro Diagnostic GI Panel Recalled Due to Temperature Exposure During Shipping

    BioFire Diagnostics is recalling FilmArray GI Panel diagnostic kits due to temperature excursions during shipping that may reduce test performance.

    Product
    In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0580-2023·2023-03-22

    Two Rivers Coffee pods recalled for undeclared peanut residue

    Two Rivers Coffee hot cocoa pods in variety packs may contain undeclared peanut residue. Consumers with peanut allergies should not consume these products and should check the affected product codes.

    Product
    Cold Stone Creamery Hot Cocoa Peanut Butter Cup Perfection packaged in single serve pods. Pods are packaged in the following Two Rivers Variety Pack boxes: -Two Rivers Coffee Hot Cocoa Pods, Single Serve Variety Sampler Pack , 40 Count UPC: 810683022554 -Two Rivers Coffee Hot C
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0603-2023·2023-03-22

    Cafe' Intermezzo Traditional Cheesecake recalled for incomplete sub-ingredient disclosure

    Epic Baking recalled 323 units of Cafe' Intermezzo Traditional Cheesecake distributed in Georgia and Tennessee for failure to list sub-ingredients on the label. All major allergens are disclosed in the product's contains statement.

    Product
    Cafe' Intermezzo Traditional Cheesecake 5.5 lbs Ingredients: Cream Cheese, Eggs, Sugar, Graham Cracker Crust (Graham Cracker Crumbs, Butter, Sugar, Vanilla Extract, Cinnamon), Vanilla Extract, Corn Starch Contains: Milk, eggs, wheat, and soy, May contain tree nuts and peanuts.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0465-2023·2023-03-22

    Buprenorphine Transdermal System Recalled for Failed Impurity Specifications

    AVEVA Drug Delivery Systems recalls nationwide batches of Buprenorphine Transdermal patches due to a degradation impurity exceeding acceptable limits during stability testing.

    Product
    Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7077-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0594-2023·2023-03-22

    Epic Baking Cheesecake Recalled for Incomplete Sub-ingredient Disclosure

    Epic Baking is recalling 625 units of Cafe' Intermezzo Cookies and Cream Cheesecake sold in Georgia and Tennessee because the firm did not list all sub-ingredients. All major allergens were disclosed in the ingredient statement.

    Product
    Cafe' Intermezzo Cookies and Cream Cheesecake 6 lbs Ingredients: Eggs, Cream Cheese, Sugar, Oreo Crust (Oreo Crust (Oreo Cookies, Butter), Oreo Cookies, Vanilla Extract, All-Purpose Flour, Hershey's Syrup, Corn Starch. Contains: Milk, eggs, wheat and soy. May contain tree nuts an
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0467-2023·2023-03-22

    FDA Recalls Colchicine Tablets Due to Failed Impurity Specifications

    Zydus Pharmaceuticals is recalling certain batches of Colchicine Tablets 0.6 mg because quality testing detected out-of-specification levels of Beta-lumicolchicine impurity. Affected lots were distributed in Arizona, Ohio, and Mississippi.

    Product
    Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC 16714-0039-02, Manufactured for: NorthStar Rx LLC., Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, c) 100 tablets per bottle, NDC 7
    Category
    Drug
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-0466-2023·2023-03-22

    Buprenorphine Transdermal System 20 mcg/hour Recalled for Specification Failure

    AVEVA Drug Delivery Systems recalls Buprenorphine Transdermal System 20 mcg/hour (Lot 51836) nationwide due to degradation product impurity exceeding specification limits during stability testing.

    Product
    Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7079-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1251-2023·2023-03-22

    BioFire BCID2 Diagnostic Panels Recalled for Temperature-Related Performance Issues

    BioFire Diagnostics is recalling BioFire BCID2 diagnostic panels that experienced temperature excursions during shipment, which may reduce their performance. Affected kits were distributed in Florida and Georgia.

    Product
    In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0620-2023·2023-03-22

    Egg Roll Wrappers Recalled Due to Undisclosed Peanut Contamination

    Baily International Foods is recalling 1,145 boxes of frozen egg roll wrappers due to peanut contamination in a sub-ingredient. The affected product was distributed to wholesalers in 19 states for restaurant and institutional use.

    Product
    Egg roll wrappers, 6" x 6" and 7" x 7", packaged in 30lb. corrugated (cardboard) boxes. Product is sold frozen.
    Category
    Food
    Distribution
    19 states
  • ModerateFDA (Food)·F-0424-2023·2023-03-22

    Women's Daily Vitamins with Iron Recalled for Sub-Potent Formulation

    Mason Vitamins is recalling People's Choice Women's Daily Vitamins with Iron because the product contains less of five key vitamins than stated on the label. Approximately 224,279 bottles are affected.

    Product
    People's Choice Women's Daily Vitamins with Iron, 30 Tablets, Dietary Supplement
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0433-2023·2023-03-22

    DF 85% Cacao Chocolate Wafers Recalled for Undeclared Peanut Residue

    Clasen Quality Chocolate is recalling DF 85% Cacao Bittersweet Chocolate Wafers (Item #54213, Lot #2347T540CL14) because the product may contain undeclared peanut residue, which poses a risk to consumers with peanut allergies.

    Product
    DF 85% Cacao Bittersweet Chocolate Wafer, Item # 54213. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Chocolate, Sugar, Sunflower Lecithin (an emulsifier), and Natural Vanilla Flavor. Distributed By: Clasen Quality Chocolate, 5126 West Terrace Drive, Madison, WI
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Food)·F-0596-2023·2023-03-22

    Lemon Torte Recall: Undeclared Food Colorants in Product

    Epic Baking's Cafe' Intermezzo Heavenly Lemon Torte contains undeclared food colorants (Yellow 5, Yellow 6, and Red 40) not listed on the label. The product was distributed in Georgia and Tennessee.

    Product
    Cafe' Intermezzo Heavenly Lemon Torte 6lbs Ingredients: Yellow Cake, Water, Vegetable Oil, Lemon Buttercream Frosting (Sugar, Shortening, Lemon Jell-O, Vanilla Extract, Lemon Emulsion, Lemon Extract, Salt, Yellow Food Color), Lemon Juice, Lemon Gelatin, Lemon Curd, Lemon Cream Ch
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0464-2023·2023-03-22

    Evamist (Estradiol) Transdermal Spray Recalled for Failed Content Uniformity

    Padagis US LLC is recalling 43,238 cartons of Evamist (Estradiol) transdermal spray nationwide because the spray content uniformity specification for standard deviation was not met at the 18-month stability time point.

    Product
    EVAMIST — EVAMIST (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0598-2023·2023-03-22

    Cake Recall: Cafe' Intermezzo Torte Missing Red 40 Ingredient Declaration

    Epic Baking is recalling Cafe' Intermezzo Light and Dark Torte because the product failed to disclose Red 40 food coloring in its ingredient list. The recall affects 65 tortes distributed to Georgia and Tennessee.

    Product
    Cafe' Intermezzo Light and Dark Torte 5 lbs Ingredients: Dark Chocolate Cake, Water, Vegetable Oil, Coffee, Cream Cheese Frosting (Cream Cheese, Sugar, Butter, Shortening, Vanilla Extract), Chocolate Pudding Mix, Chocolate Cake Crumbs, Hershey's Syrup, White Chocolate Flutes. Con
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0592-2023·2023-03-22

    Café Intermezzo Chocolate Raspberry Torte Recalled for Undeclared Red 40

    Epic Baking is recalling Café Intermezzo Chocolate Raspberry Torte products because they contain undeclared Red 40, a color additive. The affected products were distributed in Georgia and Tennessee.

    Product
    Cafe' Intermezzo Chocolate Raspberry Torte Net Weight 6.13 lbs Ingredient: Dark Chocolate Cake, Water, Vegetable Oil, Coffee, Raspberry Preserves, Chocolate Pudding Mix, Chocolate Buttercream Frosting (Sugar, Shortening, Milk, Cocoa Powder, Vanilla Extract, Salt). Contains: Milk
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0462-2023·2023-03-22

    Clobazam tablets recalled for potential manufacturing cross-contamination risk

    Breckenridge Pharmaceuticals is recalling certain lots of Clobazam 10 mg tablets due to a potential cross-contamination risk stemming from manufacturing process deviations.

    Product
    Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-900-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0609-2023·2023-03-22

    Organic Sunflower Lecithin Powder Recalled for Undeclared Peanut Allergen

    Navada Imports is recalling Organic Sunflower Lecithin Powder (44 lb boxes) due to undeclared peanut allergen. The product was distributed to a distributor in Missouri and then nationwide to manufacturers.

    Product
    Organic Sunflower Lecithin Powder Packaged in 44 lb. (20 kg.) boxes
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0425-2023·2023-03-22

    Dietary Supplement Sub-Potency Recall: Healthy Sense Daily Multiple with Iron

    Mason Vitamins is recalling Healthy Sense Daily Multiple with Iron dietary supplements because the product contains insufficient levels of Vitamins A, B12, B5, C, and E compared to label claims.

    Product
    Healthy Sense Daily Multiple with Iron, Dietary Supplement, 20 Tablets
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-0588-2023·2023-03-22

    Cannoli Cheesecake Recall: Undeclared Yellow 5 and Red 40 Color Additives

    Epic Baking is recalling Cafe' Intermezzo Cannoli Cheesecake tortes distributed in Georgia and Tennessee due to undeclared Yellow 5 and Red 40 color additives not listed on the label. No illnesses have been reported.

    Product
    Cafe' Intermezzo Cannoli Cheesecake 7 lbs Ingredients: Egg, Cream Cheese, Sugar, Ricotta Cheese, Whipped Cream, Graham Cracker Crust (Graham Cracker Crumbs, Butter, Sugar, Vanilla Extract, Cinnamon), All-Purpose Flour, Chocolate Chips, Cannoli Cookies, Orange Syrup, Chocolate But
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0590-2023·2023-03-22

    Cheesecake Brownie Recalled for Undeclared Artificial Food Colorants

    Epic Baking's Cafe' Intermezzo Chocolate Candy Brownie Cheesecake was recalled for containing undeclared artificial food colorants. Approximately 98 units were distributed to Georgia and Tennessee.

    Product
    Cafe' Intermezzo Chocolate Candy Brownie Cheesecake 6.5 lbs Ingredients: Cream Cheese, Eggs, Sugar, Brownie Batter, Pretzel Graham Cracker Crust (Graham Cracker Crumbs, Butter, Sugar, Pretzels, Cocoa Powder, Vanilla Extract), Chocolate Ganache (Chocolate Chips, Heavy Cream), M&M
    Category
    Food
    Distribution
    2 states
  • LowFDA (Food)·F-0593-2023·2023-03-22

    Cafe' Intermezzo Cookie Dough Cheesecake Recalled for Incomplete Sub-Ingredient Labeling

    Epic Baking recalls 102 units of Cafe' Intermezzo Cookie Dough Cheesecake distributed to Georgia and Tennessee due to incomplete sub-ingredient labeling. All major allergens are properly disclosed.

    Product
    Cafe' Intermezzo Cookie Dough Cheesecake 7.5 lbs Ingredients: Cream Cheese, Eggs, Sugar, Whipped Cream, Chocolate Ganache (Chocolate Chips, Heavy Cream), Cocoa Crust (Graham Crackers, Butter, Sugar, Cocoa Powder, Vanilla Extract), Chocolate-Dipped Cookies (Chocolate Chips, Butter
    Category
    Food
    Distribution
    2 states
  • LowFDA (Food)·F-0591-2023·2023-03-22

    Cafe' Intermezzo Chocolate Peanut Butter Cheesecake Recalled for Missing Sub-Ingredient Information

    Epic Baking is recalling 134 units of Cafe' Intermezzo Chocolate Peanut Butter Cup Cheesecake distributed to Georgia and Tennessee because the firm failed to list sub-ingredients on the label.

    Product
    Cafe' Intermezzo Chocolate Peanut Butter Cup Cheesecake 6.5 lbs Ingredients: Cream Cheese, Eggs, Sugar, Chocolate Ganache (Chocolate Chips, Heavy Cream), Peanut Butter, Graham Cracker Crust (Graham Cracker Crumbs, Butter Sugar, Vanilla Extract, Cinnamon), Reese's Cups, Vanilla Ex
    Category
    Food
    Distribution
    2 states
  • LowFDA (Food)·F-0602-2023·2023-03-22

    Epic Baking Recalls Tiramisu Cheesecake Due to Incomplete Ingredient Labeling

    Epic Baking recalls Cafe' Intermezzo Tiramisu Cheesecake (6.5 lbs) shipped to GA and TN because sub-ingredients were not fully listed on the label, though all major allergens were disclosed.

    Product
    Cafe' Intermezzo Tiramisu Cheesecake 6.5 lbs Ingredients: Eggs, Cream Cheese, Sugar, Coffee, Whipped Cream, Cocoa Crust (Graham Crackers, Butter, Sugar, Cocoa Powder, Vanilla Extract), Cocoa Powder, Corn Starch, Lady Fingers Mixture (Coffee, Lady Fingers, Kapali Coffee Liqueur, E
    Category
    Food
    Distribution
    2 states
  • LowFDA (Food)·F-0606-2023·2023-03-22

    Epic Baking Cheesecake Recalled for Incomplete Sub-Ingredient Labeling

    Epic Baking is recalling Cafe' Intermezzo White Chocolate Raspberry Cheesecake because sub-ingredients were not listed on the product label, though major allergens were properly disclosed.

    Product
    Cafe' Intermezzo White Chocolate Raspberry Cheesecake 6 lbs Ingredients: Eggs, Cream Cheese, Sugar, White Chocolate Ganache (White Chocolate, Heavy Cream), Graham Cracker Crust (Graham Cracker Crumbs, Butter, Sugar, Vanilla Extract, Cinnamon), Raspberries, Raspberry Syrup, Vanill
    Category
    Food
    Distribution
    2 states
  • LowFDA (Food)·F-0586-2023·2023-03-22

    Cafe' Intermezzo B-52 Cheesecake Recalled for Missing Sub-Ingredient Disclosure

    Epic Baking recalls Cafe' Intermezzo B-52 Cheesecake due to incomplete ingredient labeling. All major allergens are properly listed, but the product failed to disclose sub-ingredients of compound ingredients.

    Product
    Cafe' Intermezzo B-52 Cheesecake 6 lbs Ingredients: Eggs, Cream Cheese, Sugar, White Chocolate, Chocolate Ganache (Chocolate Chips, Heavy Cream), Oreo Crust (Oreo Cookies, Butter), Chocolate Buttercream Frosting (Sugar, Shortening, Milk, Cocoa Powder, Vanilla Extract, Salt), Iris
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·23E022000·2023-03-20

    Meritor Recalls Front Drive Steer Axles Due to Loose Fasteners

    Meritor is recalling specific front drive steer axles because fasteners may not be tightened sufficiently. This defect could cause axle separation and loss of vehicle control.

    Product
    STEERING:CRITICAL FASTENERS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V186000·2023-03-20

    Kentucky Trailer XL-12 Recalled for Winch Remote Water Ingress Risk

    Kentucky Trailer is recalling 2021-2022 XL-12 trailers because water in the winch remote can cause corrosion and unintentional operation, increasing injury risk.

    Product
    KENTUCKY TRAILER — KENTUCKY TRAILER XL-12
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V184000·2023-03-20

    Prevost Recalls One 2023 H3-45 Bus for Emergency Exit Defect

    Prevost is recalling one 2023 H3-45 bus because the emergency exit window may require excessive force to open, potentially delaying escape during an emergency.

    Product
    PREVOST — PREVOST H3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V187000·2023-03-20

    INFINITI QX50 and QX55 vehicles recalled for defective front door lock

    Nissan North America is recalling certain 2022 INFINITI QX50 and 2023 QX55 vehicles due to an incorrect door latch that may prevent the front right-side door from locking automatically, potentially allowing the door to open during a crash.

    Product
    INFINITI — INFINITI QX50, QX55
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V183000·2023-03-20

    Prevost Recalls H3-45 Buses for Hazard Light Software Defect

    Prevost is recalling 2022-2023 H3-45 buses because hazard lights may not flash simultaneously when the ignition is off, increasing crash risk.

    Product
    PREVOST — PREVOST H3-45 VIP, H3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V182000·2023-03-20

    Forest River Continental Cargo recalled for winch remote water intrusion

    Forest River Continental Cargo trailers with Warn wireless winch remotes are recalled. Water intrusion can corrode the remote's circuit board, causing unintended winch operation and injury risk.

    Product
    FOREST RIVER — FOREST RIVER CONTINENTAL CARGO, CARGO MATE, CROSS BOW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V178000·2023-03-17

    Mercedes-Benz Recalls GLE and GLS Models for Rear Window Trim Defect

    Mercedes-Benz is recalling 70,225 GLE and GLS vehicles because rear door window trim bars may detach while driving, creating a road hazard.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, MERCEDES-MAYBACH AMG GLS63 4MATIC+, GLS 580 4MATIC, GLS 450 4MATIC, AMG GLE63 S 4MATIC+
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·009-2023·2023-03-17

    WOW Frozen Food Recalls Uninspected Frozen Meat and Poultry Sfihas

    WOW Frozen Food LLC is recalling approximately 488 pounds of frozen sfihas products produced without federal inspection. The items were sold in Florida and via Instagram.

    Product
    WOW Frozen Food LLC Recalls Frozen Meat and Poultry Sfihas Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·008-2023·2023-03-17

    Hoyo Recalls Frozen Beef Sambusa Due to Possible Metal Contamination

    Hoyo, SBC is recalling approximately 1,046 pounds of frozen beef sambusa products due to possible contamination with thin, wire-like metal.

    Product
    Hoyo, SBC — Hoyo, SBC Recalls Frozen, Ready-To-Eat Beef Sambusa Product Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·23V177000·2023-03-17

    Mercedes-Benz Recalls GLE and GLS Models for Fire Risk

    Mercedes-Benz is recalling certain 2020-2021 GLE and GLS models because incorrectly installed air conditioner drain hoses may cause water intrusion, increasing the risk of fire or electrical failure.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG GLE63, GLE 580, MAYBACH GLS600, AMG GLE53
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V176000·2023-03-17

    Porsche Taycan Seat Belt Warning System Malfunction Recall

    Porsche is recalling 2020-2023 Taycan models due to a malfunctioning seat belt warning system that may fail to alert unbelted passengers. Dealers will update the instrument cluster software free of charge.

    Product
    PORSCHE — PORSCHE TAYCAN 4S, TAYCAN GTS, TAYCAN TURBO, TAYCAN 4 CROSS TURISMO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23161·2023-03-17

    Mockingbird Single Strollers Recalled Due to Fall Hazard

    Mockingbird LLC is recalling about 25,390 Single Strollers because the lower side of the frame can crack, posing a fall risk to children. The company is offering a free frame reinforcement kit.

    Product
    Mockingbird Single Strollers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V175000·2023-03-17

    2020-2023 CAN-AM Spyder and Ryker Motorcycles Brake Light Defect

    CAN-AM is recalling 2020-2023 Spyder RT and 2022-2023 Ryker motorcycles because brake lights may remain illuminated when the brake pedal is not pressed. This can prevent other motorists from seeing actual braking and increase crash risk.

    Product
    CAN-AM — CAN-AM SPYDER RT, RYKER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V180000·2023-03-17

    Hyundai Palisade windshield wiper motor failure due to ice and snow

    Hyundai is recalling 2021-2023 Palisade vehicles because the windshield wiper motor may fail due to snow or ice buildup, reducing visibility and increasing crash risk.

    Product
    HYUNDAI — HYUNDAI PALISADE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V181000·2023-03-17

    Hyundai Santa Cruz and Santa Fe recalled for tow hitch fire hazard

    Hyundai is recalling 2019-2023 Santa Fe and related variants plus 2022-2023 Santa Cruz vehicles equipped with tow hitch harnesses. Water accumulation in the harness module may cause electrical short and fire.

    Product
    HYUNDAI — HYUNDAI SANTA FE PLUG-IN HYBRID, SANTA FE HYBRID, SANTA CRUZ, SANTA FE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V179000·2023-03-17

    2023 Kia Carnival Recall: Tow Hitch Fire Risk

    Kia is recalling 2022-2023 Carnival vehicles with tow hitch harnesses that may accumulate water, causing electrical shorts that can result in fire.

    Product
    KIA — KIA CARNIVAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·23734·2023-03-16

    Polaris Sportsman ATVs Recalled for Fire and Brake Loss Hazards

    Polaris is recalling model years 2021–2023 Sportsman 450 and 570 ATVs because an improperly assembled wiring harness can contact the brake line and vehicle frame, resulting in front brake loss and fire.

    Product
    Model Years 2021-2023 Sportsman 450 and 570 All-Terrain Vehicles (ATVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23E021000·2023-03-16

    Ducati Recalls Desert X Soft Side Bags Due to Fire Risk

    Ducati is recalling 65 Desert X Soft Side Bags Kits because the right-side bag may contact the exhaust, posing a fire and crash risk.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V172000·2023-03-16

    2023 Cadillac XT6 Transmission Defect Recall for Half-Shaft Disengagement

    General Motors is recalling 2023 Cadillac XT6 and related vehicles due to a transmission defect. An incorrectly built sun gear can cause the half-shaft to disengage, risking loss of drive power or vehicle rollaway.

    Product
    CADILLAC — CADILLAC, CHEVROLET, GMC XT5, BLAZER, XT6, TRAVERSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V169000·2023-03-16

    Keystone Cougar travel trailers recalled for missing emergency exit window

    Keystone is recalling certain 2022-2023 Cougar travel trailers that may lack a required emergency exit window, creating a safety hazard in emergency situations. Owners should contact Keystone customer service for a free inspection and replacement if needed.

    Product
    KEYSTONE — KEYSTONE COUGAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23158·2023-03-16

    STIHL Docking Stations for iMOW Robotic Mowers Recalled for Fire Hazard

    STIHL is recalling about 2,700 iMOW docking stations that can short-circuit when exposed to moisture, creating a fire hazard. Eight reports of thermal overheating and two fires have been reported; no injuries.

    Product
    STIHL docking stations sold with STIHL iMOW® robotic lawn mowers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23156·2023-03-16

    Fredericksburg Farms 10-Ounce Scented Candles Recalled for Laceration Hazard

    Fredericksburg Farms is recalling about 6,500 scented candles with glass lids because some lids are too tight, causing jars to break when forcibly opened. The company has received four reports of hand lacerations.

    Product
    Fredericksburg Farms 10 Ounce Scented Candles with Glass Lids
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23154·2023-03-16

    Pfizer Recalls Nurtec ODT Prescription Tablets for Non-Child-Resistant Packaging

    Pfizer is recalling Nurtec® ODT (rimegepant) 75mg tablets because the blister card packaging is not child-resistant as required by law, posing a poisoning risk to children who may access and swallow the contents.

    Product
    Nurtec® ODT (rimegepant) orally disintegrating tablets, 75mg 8-Unit Dose blister pack
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·23159·2023-03-16

    IKEA LETTAN Mirrors Recalled Due to Laceration Hazard

    IKEA is recalling LETTAN flat mirrors because plastic wall fittings can break and cause the mirror to fall, creating a laceration risk. About 22,400 units in the U.S. are affected.

    Product
    IKEA LETTAN Mirrors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23155·2023-03-16

    Ecoxall Sodium and Potassium Hydroxide Products Recalled for Non-Compliant Packaging

    Ecoxall is recalling sodium hydroxide and potassium hydroxide products sold on Amazon because the packaging does not meet child-resistant requirements under the Poison Prevention Packaging Act. The products pose a risk of chemical burns and skin or eye irritation.

    Product
    Ecoxall Sodium and Potassium Hydroxide
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23157·2023-03-16

    Sunbeam Queen Size Heated Blankets Recalled for Fire and Burn Hazards

    Sunbeam Queen Size Heated Blankets (model 32810027) can overheat, posing fire and burn hazards. The firm has received 13 reports of overheating with no injuries reported. Consumers should stop using them immediately and contact Star Elite for a refund.

    Product
    Sunbeam® Queen Size Heated Blankets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·23V171000·2023-03-16

    2023 International Trucks Recalled for Parking Brake Defect

    Navistar is recalling certain 2023 International trucks because the Intellipark Parking Valve Module can fail to engage the parking brake, risking vehicle rollaway. The manufacturer will replace the defective component.

    Product
    INTERNATIONAL — INTERNATIONAL LT, HV, HX, RH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V174000·2023-03-16

    Honda Odyssey Rearview Mirror Glass May Detach, Reducing Visibility

    Honda is recalling certain 2020-2022 model year Odyssey, Passport, Pilot, and Ridgeline vehicles because heating pads behind the side-view mirrors may not be bonded properly, allowing mirror glass to detach and reduce visibility.

    Product
    HONDA — HONDA ODYSSEY, PILOT, PASSPORT, RIDGELINE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1148-2023·2023-03-15

    Cardiosave Rescue intra-aortic balloon pump may shut down unexpectedly

    The Cardiosave Rescue intra-aortic balloon pump may suddenly stop working due to communication failure between internal circuit boards, interrupting patient therapy and threatening hemodynamic stability.

    Product
    Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0455-2023·2023-03-15

    Hand Sanitizer Recalled for Methanol and Acetaldehyde Contamination

    Snowy Range Blue hand sanitizer is recalled due to FDA findings of methanol, acetaldehyde, and acetal above permissible limits. The product was distributed nationwide across all lot codes.

    Product
    Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution, 4fl. oz. [118mL], Distributed by Reliable Products, LLC, Cheyenne, WY 82003, NDC 75288-100-04.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0456-2023·2023-03-15

    Drug Recall: Pharmedica Non-Sterile MSM Drops Due to Contamination

    Pharmedica USA recalled Purely Soothing 15% MSM Drops nationwide due to non-sterility concerns. The voluntary Class I recall affects approximately 1,904 bottles distributed via e-commerce and trade shows.

    Product
    Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31034 91382 9; and b) 30 ml, 1.014 fl oz bottle, UPC 7 31034 91379 9; Manufactured by: Pharmedica USA, Phoenix, AZ.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0411-2023·2023-03-15

    JSJ ZSR Cake recalled for undeclared egg allergen

    Titans Global Inc. is recalling JSJ ZSR Cake due to undeclared egg on the label. The recall affects 12,432 units distributed to five retail locations in California.

    Product
    JSJ ZSR Cake 3.35 oz (95g) 28 units per case produced date: 2022/11/08
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1146-2023·2023-03-15

    Cardiosave Rescue Intra-Aortic Balloon Pumps recalled for connection failure

    Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to a coiled cord cable connection failure that may cause unexpected device shutdown and loss of communication.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0410-2023·2023-03-15

    JSJ Chocolate Cake Recalled for Undeclared Egg Allergen

    Titans Global Inc. is recalling JSJ Chocolate Cake due to undeclared egg not listed on the label. The recall affects 12,432 units distributed to five retail locations in California.

    Product
    JSJ Chocolate Cake 3.35 oz (95g) 28 units per case produced date: 2022/11/08
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·23V167000·2023-03-15

    2023 Alliance RV Valor travel trailers recalled for incorrect wheel assemblies

    Alliance RV is recalling certain 2023 Valor 21T15 travel trailers with incorrect wheel and tire assemblies that may become overloaded. Overloaded tires can fail and increase the risk of crashes.

    Product
    ALLIANCE RV — ALLIANCE RV VALOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1147-2023·2023-03-15

    Cardiosave Hybrid IABP Recalled for Risk of Unexpected Shutdown

    The Cardiosave Hybrid intra-aortic balloon pump (IABP) is being recalled because it may unexpectedly shut down due to communication loss between internal components. The shutdown could interrupt therapy in cardiac patients and compromise their hemodynamic stability.

    Product
    Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998-UC-0800-52* 0998-UC-0800-53* 0998
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0417-2023·2023-03-15

    Chukar Cherries Cherry Bombs Recalled Nationwide for Undeclared Hazelnuts

    Chukar Cherry Company is recalling Cherry Bombs Bits 'n Pieces chocolate candy nationwide due to undeclared hazelnuts, a food allergen.

    Product
    Chukar Cherries Cherry Bombs Bits 'n Pieces, item #21508, net wt. 12 oz. (340g). UPC 0 11261 21508 9. Product is packaged in clear plastic film pouch. INGREDIENTS: Milk, Bittersweet, Semisweet, and White Chocolate (Sugar, Unsweetened Chocolate processed with potassium carbonate
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0412-2023·2023-03-15

    JSJ DMC Leaf Cake recalled due to undeclared egg allergen

    JSJ DMC Leaf Cake (3.35 oz, produced 2022/11/08) has been recalled because egg is present but not declared on the label. The recall affects 12,432 units distributed to 5 retail locations in California.

    Product
    JSJ DMC Leaf Cake 3.35 oz (95g) 28 units per case produced date: 2022/11/08
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1145-2023·2023-03-15

    Cardiosave Hybrid IABP Devices Recalled for Unexpected Shutdown Risk

    Datascope Corp. is recalling Cardiosave Hybrid IABP devices due to a connection failure that may cause unexpected shutdown during use. The failure prevents communication between the device's display head and base unit.

    Product
    Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1217-2023·2023-03-15

    Heartsine Samaritan PAD defibrillators distributed with incorrect language configuration

    Thirteen automated external defibrillators with incorrect language configuration have been recalled by HeartSine Technologies. The wrong language setting could delay or prevent therapy delivery in cardiac emergencies.

    Product
    Heartsine Samaritan PAD: SAM 350P semi-automatic defibrillator, SAM 360P fully automatic defibrillator, SAM 500P semi-automatic defibrillator with CPR Advisor
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-1234-2023·2023-03-15

    TMJ Reconstruction Prosthesis Recalled for Lacking FDA Regulatory Approval

    A patient-fitted temporomandibular (TMJ) reconstruction prosthesis from Stryker Leibinger was recalled after being shipped without FDA regulatory approval. The single device distributed to a customer in Massachusetts has not been evaluated for safety and effectiveness.

    Product
    Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0434-2023·2023-03-15

    Heparin Sodium in Dextrose Injection Recalled for Low Anticoagulant Potency

    B. Braun Medical Inc. is recalling Heparin Sodium in Dextrose Injection (Lot J2C017) due to subpotent anti-Factor IIa activity, which may reduce anticoagulant effectiveness.

    Product
    HEPARIN SODIUM IN DEXTROSE — HEPARIN SODIUM IN DEXTROSE (HEPARIN SODIUM AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0433-2023·2023-03-15

    Eye Drop Recall: Brimonidine Tartrate Due to Cracked Bottle Caps

    Apotex Corp. is recalling Brimonidine Tartrate eye drops (67,056 bottles nationwide) because cracks in bottle caps may compromise sterility and expose patients to contamination.

    Product
    BRIMONIDINE TARTRATE — BRIMONIDINE TARTRATE (BRIMONIDINE TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0444-2023·2023-03-15

    FDA Drug Recall: Phenylephrine IV Bags Recalled for Manufacturing Deviations

    Denver Solutions recalls 1,212 units of Phenylephrine HCl IV bags nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The voluntary recall affects products distributed across the U.S. including government facilities.

    Product
    Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0438-2023·2023-03-15

    NatraBio Cold and Sinus Nasal Spray Recalled for Manufacturing Deviation

    Nutraceutical Corporation is recalling NatraBio Cold & Sinus Nasal Spray (0.8 FL Oz) lot 222016 due to manufacturing deviations and product discoloration. The product was distributed nationwide.

    Product
    NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions NatraBio Shelburne Falls, MA 01370 USA, UPC 3 71400 55711 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0436-2023·2023-03-15

    Verapamil Hydrochloride Tablets Recalled for Failed Dissolution Specification

    Amerisource Health Services LLC is recalling 422 cartons of Verapamil Hydrochloride Extended-Release Tablets, 120 mg due to failed dissolution testing. The tablets did not meet specifications for drug release.

    Product
    Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2023·2023-03-15

    Radiation Therapy System Software Issue May Cause Unexpected Dose

    Sensus Healthcare recalls 23 units of the SRT-100 Vision superficial X-ray radiation therapy system due to a software dose timer malfunction that may result in unexpected radiation delivery to patients.

    Product
    Sensus Healthcare Inc, SRT-100 Vision IPX 0, HFUS Module IPX 1, with software version 1.9.2; Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1232-2023·2023-03-15

    Cardiosave Rescue Pump Recall for Defective O-Rings Causing Helium Leaks

    Datascope is recalling 47 Cardiosave Rescue cardiac pump units due to damaged O-rings on the quick disconnect fitting causing helium leaks that interrupt therapy.

    Product
    Cardiosave Rescue. Model Number: 0998-00-0800-83.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1210-2023·2023-03-15

    Simplexa Flu A/B & RSV Diagnostic Kits Recalled for Leaking Components

    DiaSorin is recalling 4,142 Simplexa Flu A/B & RSV Direct Gen II diagnostic kits due to leaking Direct amplification Discs that may cause contamination, cross-contamination, invalid test results, and system error codes.

    Product
    Simplexa Flu A/B & RSV Direct Gen II, REF: MOL2655; including Reaction Mix REF: MOL2656; with previous assay definition v5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0406-2023·2023-03-15

    Rao's Roasted Peppers with Portobello Mushrooms Recalled for Undeclared Pine Nuts

    Sunny Dell, Inc. recalls Rao's Homemade Roasted Peppers with Portobello Mushrooms (12 oz) for undeclared pine nuts. Product distributed to Northeast U.S. Consumers with pine nut allergies should be aware of this recall.

    Product
    Rao's Homemade Roasted Peppers with Portobello Mushrooms Net WT. 12OZ (340g) UPC:74749001106 Packaged in glass jars, 12 packages per cases
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1225-2023·2023-03-15

    CardioMEMS Heart Failure Sensor May Give Inaccurate Readings at High Elevations

    St. Jude Medical is recalling 317 CardioMEMS PA Sensors due to operation outside their intended frequency range at elevations above 2,000 feet, which may cause inaccurate pressure readings or signal acquisition problems.

    Product
    CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2023·2023-03-15

    Cardiosave Rescue IABP Helium Regulator Failures May Impair Function

    Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to helium regulator failures that may cause insufficient helium levels when the pump console is docked. The defect may affect device operation.

    Product
    Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, and 0998-00-0800-85
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1223-2023·2023-03-15

    CardioMEMS PA Sensor Operates Outside Frequency Range at High Elevations

    Select CardioMEMS CM2000 PA sensors may operate outside their intended frequency range above 2,000 feet elevation, potentially causing inaccurate readings or signal acquisition problems in heart failure monitoring.

    Product
    CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1212-2023·2023-03-15

    Blood Sample Collection Kits Shipped With Incorrect Identification Labels

    LetsGetChecked Blood Sample Collection kits were distributed with incorrect shipping labels that assigned samples to wrong users. This could result in incorrect Hepatitis C Virus test results or rejected samples due to demographic mismatches.

    Product
    LetsGetChecked Blood Sample Collection kit-In vitro diagnostic medical device specifically intended for the primary containment and preservation of blood samples.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1211-2023·2023-03-15

    Sprint 200 Wheeled Stretcher Siderail Labeling Update to Prevent Falls

    FDA is updating labeling for Sprint 200 wheeled stretchers to ensure the siderail is secured to a locked position, preventing potential patient falls and injuries. 335 units (310 US, 25 international) are affected.

    Product
    Sprint 200 wheeled stretcher, Item numbers 1ES200-7, 1ES210-1, and 1ES211-1.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Food)·F-0416-2023·2023-03-15

    Shirakiku Shichimi Togarashi Spice Recalled for Undeclared Sesame

    Shirakiku Shichimi Togarashi spice (Lot 12262023) is recalled because it contains undeclared sesame due to potential product mix-up. The 2,617 packages were distributed nationwide and internationally.

    Product
    SPICE SHICHIMI TOGARASHI 300g UPC: 074410341213 Brand: Shirakiku Distributed by: Wismettac Asian Foods, Inc. Santa Fe Springs, CA 90670 Product of China
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0418-2023·2023-03-15

    Given Imaging SmartBar Cereal Bar Recalled for Potential Tobacco Beetle Contamination

    Given Imaging Ltd. is recalling SmartBar Cereal Bars because they may be contaminated with tobacco beetles. Consumers should not consume the affected product.

    Product
    Given Imaging SmartBar Cereal Bar; Net Weight 2.53 oz (72 g); Ingredients: glucose syrup, soy crisps, oats, pea protein, puffed wheat (wheat, sugar), concentrated pineapple juice, fructose, dried cranberries (cranberries, sugar, sunflower oil), dried apples, brown sugar, invert s
    Category
    Food
    Distribution
    38 states
  • HighFDA (Drugs)·D-0439-2023·2023-03-15

    NaturalCare bioAllers Homeopathic Drops Recalled for Manufacturing Quality Defect

    Nutraceutical Corporation is recalling NaturalCare bioAllers homeopathic liquid drops nationwide due to a raw material manufacturing quality issue. The recall affects lot 222076 with an expiration date of 03/27.

    Product
    NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% Alcohol, 1 FL OZ( 30mL), Mfd. for Nutraceutical Corp. NaturalCare Park City, UT, 84098 USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1214-2023·2023-03-15

    Siemens epoc Host 2 blood gas analyzer recalled for pO2 measurement quality control issue

    Siemens is recalling 22,156 units of the epoc Host 2 blood gas analyzer due to pO2 measurement quality control issues related to barometric pressure. The devices are distributed worldwide.

    Product
    epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 10736388 epoc Host 2, China 10736389 epoc Host 2, Japan 10736390 epoc Host 2, Refurbished 10736393 epoc Host 2, Canada, Refurbished 10736394 epoc Host 2, Japanese, Refurbished
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1224-2023·2023-03-15

    CardioMEMS PA Sensor models affected by radio-frequency range at high elevations

    St. Jude Medical recalls CardioMEMS PA Sensors that may operate outside intended frequency range above 2,000 feet elevation, risking inaccurate readings in heart failure monitoring. Approximately 1,905 units affected.

    Product
    CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart failure (HF) patients. The system measures changes in PA pressure which physicians use
    Category
    Medical Device
    Distribution
    Distributed nationwide

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