The Recall Desk

Archive

November 2023 recalls

649 recalls were announced in November 2023.

What the numbers show

Critical
20
Severe
190
High
373
Moderate
63
Low
3

Of the 649 recalls this month scored against our rubric, 3% are Critical, 29% are Severe.

Which agencies issued them

101–200 of 649

  • HighFDA (Devices)·Z-0375-2024·2023-11-29

    Biomet Compress Device Anchor Plugs Recalled for Metal Burrs

    Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent proper device function during surgery. The defect could result in extended surgical time.

    Product
    Compress Device Segmental Anchor Plug, 20 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178410
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0333-2024·2023-11-29

    Gastroscope Devices Recalled for Inadequate Channel Drying Process

    Aizu Olympus recalls 680 gastroscope-EUS devices due to unvalidated channel drying. Water remaining in the channels poses contamination and infection risks.

    Product
    Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper digestive tract. Model Numbers: GF-UC140P-AL5, GF-UCT180, GF-UE160-AL5.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0399-2024·2023-11-29

    ORION Robotic Arm Recalled for Sudden Acceleration and Collision Risk

    The FDA recalls ORION robotic positioning arms used in radiation and radiology due to sudden acceleration or unintended movement that could cause patient collision with treatment room equipment. No injuries reported.

    Product
    ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0398-2024·2023-11-29

    Robotic patient positioning system may move unexpectedly after interruption

    The ORION System robotic arm used in radiation therapy may suddenly accelerate or move unexpectedly when motion resumes after an interruption, creating a risk of collision with stationary equipment.

    Product
    ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0113-2024·2023-11-29

    Buspirone Hydrochloride Tablets Recalled Due To Amlodipine Contamination Risk

    FDA recalls Buspirone Hydrochloride 10 mg tablets due to potential contamination with foreign Amlodipine Besylate tablets. The recall affects 1,344 blister cards distributed nationwide.

    Product
    BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0337-2024·2023-11-29

    Hysterofiberscope Model HYF-XP Channel Drying Process Flaw Poses Infection Risk

    Aizu Olympus is recalling HYF-XP hysterofiberscopes because the channel air drying process was not validated. Some repaired units have wet channels that could harbor contamination and pose infection risk.

    Product
    Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0377-2024·2023-11-29

    Biomet Anchor Plugs Recalled: Metal Burrs Prevent Proper Assembly

    Biomet's Compress Device Segmental Anchor Plugs are being recalled due to metal burrs in assembly holes. The defect prevents drill pins from passing through, potentially extending surgical time during implantation procedures.

    Product
    Compress Device Segmental Anchor Plug, 24 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178414
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0320-2024·2023-11-29

    Medtronic Mo.Ma Ultra cerebral protection device labeling error recalled

    Medtronic is recalling 2,767 units of the Mo.Ma Ultra Proximal Cerebral Protection Device due to labeling errors on the manifold that result in incorrect identification of inflation and deflation ports.

    Product
    Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0112-2024·2023-11-29

    Prescription esomeprazole magnesium capsules recalled for failed impurity specifications

    Glenmark Pharmaceuticals recalled esomeprazole magnesium 20mg capsules nationwide due to out-of-specification organic impurities detected during stability testing. No illnesses have been reported.

    Product
    ESOMEPRAZOLE MAGNESIUM — ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE MAGNESIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0379-2024·2023-11-29

    Compress Device Short Anchor Plug recalled for potential metal burrs

    Biomet recalls Compress Device Short Anchor Plug devices due to potential metal burrs in transverse holes that may prevent proper drill and pin placement during orthopedic surgery, affecting units distributed worldwide.

    Product
    Compress Device Short Anchor Plug, 12 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178554
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0370-2024·2023-11-29

    Orthopedic Anchor Plugs Recalled for Metal Burrs Preventing Proper Installation

    Biomet is recalling Compress Device Segmental Anchor Plugs due to metal burrs in transverse holes that may prevent drills or pins from passing through, potentially extending surgical procedures.

    Product
    Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0114-2024·2023-11-29

    Lisinopril Tablets Recalled for Stray Amlodipine Tablet Contamination

    NCS Healthcare recalled Lisinopril Tablets USP 20 mg nationwide due to potential presence of stray Amlodipine Besylate 10 mg tablets in certain lots. No illnesses have been reported.

    Product
    BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0463-2024·2023-11-29

    Dietary Supplement Recalled for Subpotent Folic Acid Content

    ActiPharma is recalling ACTIRON Dietary Supplement (Lot 13309, Exp. 01/26) distributed in Puerto Rico because FDA testing found the folic acid content did not meet the label claim.

    Product
    ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bottles per case) ) (Lot 13309, Exp.: 01/26), UPC: 363102217104.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0462-2024·2023-11-29

    Frozen Gluten-Free Waffles Recalled for Potential Peanut Contamination

    Treehouse Foods is recalling multiple brands of frozen gluten-free blueberry waffles due to potential peanut contamination. Affected products were distributed in California, Iowa, Illinois, Ohio, and Texas.

    Product
    HEB Central Market Blueberry Buckwheat Gluten Free Waffle, 8.25oz, UPC 004122025365 Giant Eagle Blueberry Gluten Free Waffle, 11.3oz, UPC 030034944940 Topco Full Circle Market Gluten Free Waffles - Blueberry, 11.3oz, UPC 036800486980
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0380-2024·2023-11-29

    Compress Device Short Anchor Plugs recalled due to metal burrs

    Biomet is recalling Compress Device Short Anchor Plugs (14 MM) due to potential metal burrs in transverse holes that may prevent proper insertion during surgery. The defect may extend surgical time.

    Product
    Compress Device Short Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178556
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V803000·2023-11-28

    Cake Recalls 2020-2022 Osa Flex Electric Mopeds for Steering Defect

    Cake is recalling 2020-2022 Osa Flex electric mopeds because the aluminum steering column may fatigue and break, causing a sudden loss of steering.

    Product
    CAKE — CAKE OSA FLEX ELECTRIC MOPED
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V800000·2023-11-28

    2024 Ford Mustang brake pedal defect increases crash risk

    Ford is recalling certain 2024 Mustang vehicles because the brake pedal assembly may have been manufactured incorrectly, causing a loose brake pedal. A loose brake pedal can result in loss of braking function, increasing the risk of a crash.

    Product
    FORD — FORD MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23E092000·2023-11-28

    Chrysler Recalls Steering Column Control Modules for Signal Confusion

    Chrysler is recalling 1,240 Mopar steering column control modules that may cause high beams and turn signals to activate incorrectly, increasing crash risk.

    Product
    STEERING:STEERING CONTROL MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V799000·2023-11-28

    RAM 2500 Steering Control Module Failure May Disable Turn Signals and High Beams

    Certain 2023-2024 RAM 2500 vehicles and related models have a faulty steering column control module that may cause turn signals and high beams to malfunction, increasing the risk of a crash. Owners should contact FCA US, LLC for free repairs.

    Product
    RAM — RAM 4500, 5500, 3500, 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V798000·2023-11-26

    KME Fire Trucks Recalled for Parking Brake Defect

    KME is recalling 2021-2023 fire trucks because a valve defect may delay parking brake engagement, increasing crash risk.

    Product
    KME — KME redundant PREDATOR, SEVERE SERVICE, PREDATOR, redundant PANTHER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V797000·2023-11-24

    BMW Recalls 2014-2015 X3, X4, and X5 Models for Airbag Defect

    BMW is recalling specific 2014-2015 X3, X4, and X5 vehicles because the driver's airbag inflator may explode during deployment, posing a risk of serious injury or death.

    Product
    BMW — BMW X3, X5, X4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V795000·2023-11-23

    Micro Bird Recalls G5 School Buses Due to Wheelchair Track Defect

    Micro Bird is recalling certain G5 school buses because wheelchair track anchorages may detach during a crash, increasing injury risk.

    Product
    MICRO BIRD — MICRO BIRD G5 SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0443-2024·2023-11-22

    Frozen Ice Cream Base Recalled for Undeclared Milk Allergen and Food Colorings

    Paradise Flavors LLC recalls Dulce de Leche ice-cream base (4 oz) for undeclared milk allergen and color additives. The recall affects 210 units distributed in Florida.

    Product
    DULCE DE LECHE, Ice-cream base, Natural flavor, artificial flavor and coloring., Distributed By Paradiose Flavors LLC. 4oz (120 mL). Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0429-2024·2023-11-22

    Paradise Flavors frozen cappuccino ice-cream recalled for undeclared milk

    Paradise Flavors LLC is recalling 60 units of its frozen cappuccino ice-cream (4 oz pouches) from Florida due to undeclared milk allergen, which poses a serious risk to consumers with milk allergies.

    Product
    CAPPUCCINO, Ice-cream base, natural flavoring, artificial flavoring. PARADISE FLAVORS. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0440-2024·2023-11-22

    Paradise Flavors frozen mamey recalled for undeclared milk allergen

    Paradise Flavors LLC is recalling 80 units of frozen MAMEY product due to undeclared milk allergen. Consumers with milk allergies should not consume this product.

    Product
    MAMEY, PARADISE FLAVORS LLC, 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0455-2024·2023-11-22

    Coconut ice cream mix recalled for undeclared milk and tree nut allergens

    Paradise Flavors LLC is recalling 216 units of COCONUT/COCO ice cream mix from Florida distribution due to undeclared milk and tree nut allergens. Consumers allergic to milk or tree nuts should not consume this product.

    Product
    COCONUT/COCO ice cream mix, natural flavors, artificial flavors. 9601 Overseas Hwy, Marathon FL. 100ml 3 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0449-2024·2023-11-22

    Cookies And Cream Frozen Product Recalled for Undeclared Milk, Soy, and Wheat Allergens

    Paradise Flavors LLC is recalling 318 units of Cookies And Cream frozen product (4 oz) due to undeclared allergens: milk, soy, and wheat. The product was distributed in Florida.

    Product
    Cookies And Cream, distributed by Paradise Flavors LLC, 4 OZ, 120ML, Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0424-2024·2023-11-22

    Mint Chocolate Chip Ice Cream Recalled for Undeclared Milk and Color Additives

    Paradise Flavors LLC is recalling 112 units of Mint Chocolate Chip ice cream for containing undeclared milk and food color additives (FD&C yellow #5, blue #1, red #40). The product was distributed in Florida.

    Product
    MINT CHOCOLATE CHIP, Ice-cream base, Chocolate chips, Artificial Flavoring, Artificial color. PARADISE FLAVORS. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·23V789000·2023-11-22

    Land Rover Defender Recall for Brake Caliper Detachment Risk

    Jaguar Land Rover is recalling 121 modified 2023 Defender 130 vehicles because improperly reinstalled brake calipers may detach, reducing braking ability and increasing crash risk.

    Product
    LAND ROVER — LAND ROVER DEFENDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0433-2024·2023-11-22

    Ice Cream Base Recalled for Undeclared Milk Allergen and Food Dyes

    Paradise Flavors LLC is recalling RUM RAISIN ice-cream base (4 oz frozen pouches) distributed in Florida due to undeclared milk allergen and undeclared food dyes (FD&C yellow #5, red #40, blue #1). Consumers with milk allergies should not consume this product.

    Product
    RUM RAISIN, ice-cream base, artificial flavoring natural fruits, artificial. DISTRIBUTED PARADISE FLAVORS LLC. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0428-2024·2023-11-22

    Pink Guaba Ice Cream Mix Recalled for Undeclared Milk Allergen and Color Additives

    Paradise Flavors LLC recalls Pink Guaba ice cream mix due to undeclared milk allergen and color additives. Consumers with milk allergies should not consume this product.

    Product
    PINK GUABA, Ice-cream mix, filtered water, Natural Flavoring, sugar, Artificial color. PARADISE FLAVORS. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0452-2024·2023-11-22

    EZQUIMAL Ice Cream Base Recalled for Undeclared Allergens and Color Additives

    Paradise Flavors LLC recalls EZQUIMAL 4 oz frozen ice-cream base due to undeclared allergens (milk, tree nuts, peanuts, soy) and color additives. Product distributed in Florida.

    Product
    EZQUIMAL, ice-cream base, natural flavoring, chocolate cover, penuts. 4 OZ. DISTRIBUTED BY PARADISE FLAVORS LLC. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0460-2024·2023-11-22

    Frozen Gummybear Ice Cream Recalled for Undeclared Milk, Tree Nuts, and Food Dye

    Paradise Flavors LLC is recalling BUBBLEGUM GUMMYBEAR frozen ice cream (4 oz pouches) due to undeclared allergens—milk and tree nuts—and an undeclared color additive (FD&C Blue #1). The product was distributed within Florida only.

    Product
    BUBBLEGUM GUMMYBEAR, ice-cream base, artificial flavor. Distributed by: PARADISE FLAVORS LLC. 4 OZ, 120ML. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0451-2024·2023-11-22

    MAGNUM Ice-Cream Base Recalled for Undeclared Allergens and Color Additives

    Paradise Flavors LLC is recalling MAGNUM ice-cream base due to undeclared milk, tree nuts, peanuts, soy, and FD&C color additives. Consumers with allergies risk serious allergic reactions.

    Product
    MAGNUM, ice-cream base, natural flavoring, 4 OZ. DISTRIBUTED BY PARADISE FLAVORS LLC. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0442-2024·2023-11-22

    Ice cream base from Florida recalled for undeclared milk allergen and color additives

    Paradise Flavors LLC is recalling FLORIDA SUNRISE/CHEMIS ice cream base due to undeclared milk allergen and undeclared color additives. The product was distributed within Florida.

    Product
    FLORIDA SUNRISE/CHEMIS, Paradise Flavors LLC, Ice-cream base, natural flavoring, artificial flavor and color., DISTRIBUTED BY PARADISE FLAVORS LLC, 3 oz, 120 ML. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0432-2024·2023-11-22

    Paradise Flavors Strawberries and Cream ice cream base recalled for undeclared milk allergen

    Paradise Flavors LLC is recalling Strawberries and Cream ice cream base (4 oz) due to undeclared milk allergen. Approximately 86 units from the latest production were distributed in Florida.

    Product
    Strawberries and Cream, ice-cream base, natural flavoring. Paradise Flavors LLC. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0435-2024·2023-11-22

    Banana Bread Ice Cream Recalled for Multiple Undeclared Allergens

    Paradise Flavors LLC is recalling its Banana Bread ice cream (4 oz) due to undeclared allergens: milk, tree nuts, peanuts, soy, and wheat. The product was distributed in Florida only.

    Product
    BANANA BREAD , Ice-cream base, Natural fruit, bread, dehydrated fruit. PARADISE FLAVORS LLC. CONTAINS NUTS. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0437-2024·2023-11-22

    Paradise Flavors Key Lime Creamsicle frozen treats recalled for undeclared allergens

    Paradise Flavors is recalling Key Lime Creamsicle frozen desserts due to undeclared milk allergen and undeclared food color additives. Consumers with milk allergies should not consume this product.

    Product
    KEY LIME CREAMSICLE, Filtered water, ice-cream base, natural flavoring, artificial color, citric acid and carboxymethylcellulose. PARADISE FLAVORS. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0445-2024·2023-11-22

    Frozen ice cream product recalled due to undeclared allergens

    Paradise Flavors LLC recalled Ferrero Rocher ice-cream base distributed in Florida due to undeclared allergens: milk, tree nuts, peanuts, soy, and wheat. Consumers should not consume this product if allergic to these substances.

    Product
    Ferrero Rocher, Ice-cream base, Hazelnut, Nutella, Penuts, Cacao, Rich Chocolate, Artificial flavoring., DISTRIBUTED BY: PARADISE FLAVORS LLC. 4oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0447-2024·2023-11-22

    Pine Nut Ice Cream Bar Recalled for Undeclared Milk, Soy, Wheat, Tree Nuts

    Paradise Flavors LLC has recalled its 4 oz Pine Nut Ice Cream Bar due to undeclared allergens: milk, tree nuts, soy, and wheat. The product was distributed in Florida and poses a risk to consumers with these allergies.

    Product
    Pine Nut/Pinon, Ice Cream Bar, Ice cream base, natural flavoring, dehydrated fruit, artificial coloring, 4 oz, Paradise Flavors. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0439-2024·2023-11-22

    Paradise Flavors Rice Pudding Ice Cream Mix Recalled for Undeclared Milk

    Paradise Flavors Arroz con Leche rice pudding ice cream mix is recalled due to undeclared milk allergen. Consumers with milk allergies should not consume this product.

    Product
    ARROZ CON LECHE/RICE PUDDING, Ice cream MIX, Filtered water, Natural Rice, cinamon and caramel, DISTRIBUTOR PARADISE FLAVORS LLC, 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0461-2024·2023-11-22

    Frozen Cotton Candy with M&Ms recalled for undeclared allergens

    Paradise Flavors LLC is recalling Cotton Candy with M&Ms due to undeclared milk, peanuts, and soy allergens, plus undeclared color additives. The product was distributed in Florida.

    Product
    Cotton Candy with M&Ms, ice-cream base, M&M's, artificial flavor, food coloring. DISTRIBUTED BY PARADISE FLAVORS LLC. 4 OZ. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0434-2024·2023-11-22

    Trail Mix Ice Cream Base Recalled for Undeclared Allergens

    Paradise Flavors LLC is recalling Trail Mix/Frutas Secas ice cream base because it contains undeclared allergens: milk, tree nuts, peanuts, and soy. Consumers with allergies to these ingredients should not consume the product.

    Product
    Trail Mix/Frutas Secas, Ice-cream base, dried fruits and nuts, vanilla extract. 9301 Overseas Hwy. Marathon FL 33050. CONTAINS NUTS. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0453-2024·2023-11-22

    Paradise Flavors Frozen Chocolate Ice Cream Recalled for Undeclared Milk and Soy

    Paradise Flavors LLC is recalling frozen chocolate ice cream (4 OZ/120 ML packages) distributed in Florida due to undeclared milk and soy allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    CHOCOLATE, ice-cream base, chocolate powder, natural flavoring,. PARADISE FLAVORS, 4 OZ, 120 ML. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0425-2024·2023-11-22

    Guava Jelly Ice Cream Recalled for Undeclared Milk Allergen and Color Additives

    Paradise Flavors is recalling 86 units of frozen guava jelly ice-cream product due to undeclared milk allergen and color additives (FD&C yellow #5, yellow #8, red #40). The product was distributed only in Florida.

    Product
    GUAVA JELLY, Ice-cream base, natural flavoring, artificial coloring. PARADISE FLAVORS. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0408-2024·2023-11-22

    Ice cream recall: Undeclared egg allergen in Guilt Free vanilla

    TH Searcy LLC is recalling Guilt Free No Sugar Added Ice Cream due to undeclared egg allergen. The recall affects 34,500 retail units distributed through Walmart, Kroger, and Associated Wholesale Grocers across nine states.

    Product
    Guilt Free No Sugar Added Ice Cream Homemade Vanilla 1.5qts
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-0436-2024·2023-11-22

    Paradise Flavors Pistachio Ice Cream Base Recalled for Undeclared Allergens

    Paradise Flavors is recalling pistachio ice cream base (4 oz pouches) distributed in Florida due to undeclared milk and tree nuts. The product also contains undeclared color additives FD&C yellow #5 and blue #1.

    Product
    Pistachio, Ice-cream base, Natural Flavors, Artificial Colors. Paradise Flavors. CONTAINS NUTS. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0458-2024·2023-11-22

    Paradise Flavors Soursop Ice-Cream Base Recalled for Undeclared Milk

    Paradise Flavors is recalling its 4 oz Guavanana (soursop) ice-cream base because it contains undeclared milk, a major allergen that poses health risks to consumers with milk allergies.

    Product
    GUANAVANA (SOURSOP/GUANABANA), ice-cream base, natural flavoring. PARADISE FLAVORS. 4 OZ, 120ml. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·23E090000·2023-11-22

    Chrysler Recalls Mopar Hybrid Service Kit Battery Packs Due to Fire Risk

    Chrysler is recalling specific Mopar Hybrid Service Kit Battery Packs because they may fail internally and cause a fire while parked or driving.

    Product
    ELECTRICAL SYSTEM:PROPULSION SYSTEM:TRACTION BATTERY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0454-2024·2023-11-22

    Frozen Avocado Ice-Cream Base Recalled for Undeclared Milk and Color Additives

    Paradise Flavors LLC recalls its frozen avocado ice-cream base for undeclared milk allergen and FD&C color additives. The product was distributed in Florida and may pose a risk to milk-allergic consumers.

    Product
    Avocado, ice-cream base, Natural flavor, artificial coloring. DISTRIBUTED BY PARADISE FLAVORS LLC. 4 OZ. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0431-2024·2023-11-22

    Paradise Flavors Pina Colada Ice Cream Base Recalled for Undeclared Allergens

    Paradise Flavors is recalling 120 units of Pina Colada ice-cream base in 4 oz packages due to undeclared milk and tree nuts allergens, and undeclared color additives. Consumers with allergies should not consume this product.

    Product
    Pina Colada, ice-cream base, natural flavoring, artificial flavoring. PARADISE FLAVORS. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0423-2024·2023-11-22

    UNICORN Ice-Cream Base Recalled for Undeclared Milk Allergen and Color Additives

    Paradise Flavors LLC is recalling 216 units of UNICORN Ice-Cream Base distributed in Florida due to undeclared milk allergen and color additives (FD&C red #5, blue #1, red #3, red #40, yellow #5).

    Product
    UNICORN Ice-cream base, natural flavors, Artificial Flavoring, Artificial color. DISTRIBUTED BY PARADISE FLAVORS LLC. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0459-2024·2023-11-22

    Orange Creamcycle frozen pops recalled for undeclared milk allergen and color additives

    Paradise Flavors LLC is recalling Orange Creamcycle frozen pops due to undeclared milk allergen and undeclared color additives. The product was distributed in Florida and may pose health risks to consumers with milk allergies.

    Product
    ORANGE CREAMCYCLE, Filtered water, natural flavoring, artificial color, citric acid and carboxymethylcellulose, PARADISE FLAVORS. 4 OZ, 120ML. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0457-2024·2023-11-22

    Frozen ice cream base recalled for undeclared milk allergen and color additives

    Paradise Flavors LLC is recalling Chunky Mango frozen ice cream base for containing undeclared milk allergen and color additives. The product poses a health risk to consumers with milk allergies.

    Product
    CHUNKY MANGO, ice-cream base, natural flavoring, artificial flavor and color. 4 OZ, 120ml. DISTRIBUTED BY: Paradise Flavors LLC. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0438-2024·2023-11-22

    Frozen Chocolate Razzberry Cake Recalled for Undeclared Allergens and Color Additives

    Paradise Flavors LLC is recalling Chocolate Razzberry Cake (Gancito) frozen dessert due to undeclared milk, peanuts, soy, and wheat allergens, plus undeclared color additives.

    Product
    CHOCOLATE RAZZBERRY CAKE (GANCITO). INGREDIENTS: Icecream base, Natural flavor, artificial flavoring. Paradise Flavors. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0441-2024·2023-11-22

    Frozen Yogurt Recalled Due to Undeclared Milk and Other Allergens

    YOGOBERRY frozen yogurt (4 oz pouches) is recalled due to undeclared allergens: milk, tree nuts, peanuts, soy, and wheat. The product was distributed in Florida.

    Product
    YOGOBERRY (YOGURT WITH FRUITS), Ice cream, Mix Berries, Granola, Honey, Citric acid., PARADISE FLAVORS LLC, 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0427-2024·2023-11-22

    Butter pecan ice cream recalled for undeclared allergens and color additives

    Paradise Flavors LLC is recalling BUTTER PECAN ice cream due to undeclared milk and tree nut allergens and undeclared color additives. The product was distributed domestically in Florida.

    Product
    BUTTER PECAN, Ice-cream base, Natural flavor, graham crackers, artificial color, citric acid, artificial flavoring. Paradise Flavors. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0446-2024·2023-11-22

    Blackberry Cheesecake Ice Cream Recalled for Undeclared Allergens

    Paradise Flavors LLC is recalling Blackberry Cheesecake ice cream (4 oz) due to undeclared milk, soy, and wheat allergens. The product was distributed in Florida.

    Product
    BLACKBERRY CHEESECAKE, Ice-cream base, Natural Flavor, Cheese, Butter, crackers., 4 oz (120 ML), PARADISE FLAVORS LLC. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0456-2024·2023-11-22

    Paradise Flavors Frozen Key Lime Pie Recalled for Undeclared Allergens and Color Additives

    Paradise Flavors frozen key lime pie contains undeclared allergens (milk, soy, wheat) and color additives (FD&C yellow #5, blue #1, red #40). Consumers with allergies should not consume this product.

    Product
    KEY LIME PIE, PARADISE FLAVORS, 9601 Overseas Hwy, Marathon FL. 33050. 4 OZ. 120ml. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0448-2024·2023-11-22

    Peanut Butter Ice-Cream Base Recalled for Undeclared Allergens

    Paradise Flavors LLC is recalling peanut butter ice-cream base distributed in Florida due to undeclared allergens (milk, peanut, soy, and wheat) not listed on the label.

    Product
    PEANUT BUTTER/MAZAPAN, Ice-cream base, Natural Flavor, Artificial Color, sea salt., Distributed by PARADISE FLAVORS LLC, 4 OZ. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0426-2024·2023-11-22

    Vanilla Ice Cream Base Recalled for Undeclared Milk and Color Additives

    Paradise Flavors LLC is recalling vanilla ice cream base due to undeclared milk allergen and color additives. Consumers with milk allergies should not use this product.

    Product
    VANILLA, Ice-cream base, Natural flavor, artificial flavor and coloring. Distributed By Paradiose Flavors LLC. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0444-2024·2023-11-22

    Chocolate ice cream product recalled due to undeclared allergens

    Paradise Flavors LLC is recalling Chocolate with Almonds ice-cream products due to undeclared allergens: milk, tree nuts, peanuts, and soy. Consumers with these allergies should discard the product.

    Product
    CHOCOLATE WITH ALMONDS, ice-cream base, chocolate powder, natural flavoring, PARADISE FLAVORS, 4oz, 120 ML. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0430-2024·2023-11-22

    Paradise Flavors Sweet Corn Ice Cream Mix Recalled for Undeclared Milk and Color Additives

    Paradise Flavors recalls Sweet Corn ice cream mix distributed in Florida for undeclared milk allergen and color additives. Consumers with milk allergies risk allergic reaction from this product.

    Product
    SWEET CORN/ELOTE, Ice cream mix, natural flavoring, sea salt. PARADISE FLAVORS. 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0294-2024·2023-11-22

    CT Scanner Image Fusion Software Error Affecting Radiation Therapy Planning

    A software bug in Philips Brilliance CT scanners causes image-fusion errors, resulting in incorrect radiation therapy coordinates and potential treatment planning failures.

    Product
    Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V793000·2023-11-22

    2023-2024 Volvo VN Trucks Recalled for Accelerator Control System Defect

    Volvo Trucks is recalling certain 2023-2024 VN trucks because the accelerator pedal position sensor may disconnect, preventing the engine from returning to idle quickly. This can cause loss of vehicle control and increase crash risk.

    Product
    VOLVO — VOLVO VN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0307-2024·2023-11-22

    Medical Device Recall: KWIKSTIK Microbiological Reagent Contaminated with Aspergillus

    Microbiologics Inc recalls KWIKSTIK microbiological reagent kits due to Aspergillus flavus contamination in bulk pellets. Affected products were distributed worldwide, including the US, Italy, France, Turkey, Peru, and Mexico.

    Product
    KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0295-2024·2023-11-22

    IBA Proton Therapy System Patient Positioning Can Move Unexpectedly

    The IBA Proton Therapy System's patient positioning system can perform unexpected motions, risking patient crushing. Five US units and nine international units are affected.

    Product
    IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0310-2024·2023-11-22

    Medline Blood Culture Collection Kits Recalled for Expired Internal Components

    Medline is recalling 4,850 adult blood culture collection kits (lot numbers 23EMI373, 23EMF712, 23DMF155, 23CMH026) because components inside expired before the kit's labeled expiration date.

    Product
    ADLT BLOOD CULTURE COLLECT KIT, REF DYNDH1245
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0414-2024·2023-11-22

    Full Spectrum Hemp Oil Gummies recalled for undeclared sunflower allergen

    Tay's Sales and Distribution is recalling Full Spectrum Cold Pressed Hemp Oil Gummies due to undeclared sunflower allergen in the product. Affected products (Lot 081321) were distributed in Iowa and Illinois.

    Product
    Full Spectrum Cold Pressed Hemp Oil Gummies, Fruit Punch, 1.41 oz (4-count) and 8oz (15-count).
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0300-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall: Loose Battery Pins Risk Power Loss

    Physio-Control is recalling LIFEPAK 15 defibrillators due to a potential defect where battery pins may become loose, causing power issues.

    Product
    LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0298-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Failure

    Physio-Control is recalling LIFEPAK 15 defibrillators due to loose battery pins that may cause power failure. Users should verify device functionality immediately.

    Product
    LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0409-2024·2023-11-22

    Frozen Tuna Ground Meat Recalled Due to Bacterial Contamination and Histamine

    Takumi brand frozen tuna ground meat is being recalled due to bacterial contamination (E. coli, coliforms) and elevated histamine. The product was distributed in CA, NV, TX, and NC in August-September 2021.

    Product
    Takumi brand frozen tuna ground meat, raw but ready to eat, vacuum packaged units in fiber boxes, net wt. 11 lbs. per box. individual units were sold by weight at the point of sale. Product of Fiji, and imported by Tokai Denpun USA INC. Bellevue, WA. Vacuum package label is…
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0301-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recalled for Loose Battery Pins Causing Power Loss

    Physio-Control is recalling LIFEPAK 15 defibrillators due to potential loose battery pins that could cause power failure. Four affected units have been distributed to Arizona, California, North Carolina, New Jersey, and New York.

    Product
    LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0304-2024·2023-11-22

    LIFEPAK 15 Defibrillators Recalled Due to Potential Loose Battery Pins

    Physio-Control has recalled LIFEPAK 15 defibrillators because battery pins may become loose, causing power issues. Owners should contact the manufacturer for instructions on how to proceed.

    Product
    LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23E091000·2023-11-22

    Ricon Recalls Wheelchair Lift Warning Kits Due to Dim Beacon Lighting

    Ricon is recalling Threshold Warning System Kits for wheelchair lifts because the red beacon may not be bright enough, increasing injury risk.

    Product
    EQUIPMENT ADAPTIVE/MOBILITY:WHEELCHAIR LIFT/RAMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0318-2024·2023-11-22

    Express Dry Seal Chest Drains Recalled for Insufficient Setup Instructions

    Atrium Medical Corporation is recalling Express Dry Seal Chest Drains (models 4000-100N and 4050-100N) due to inadequate instructions for proper catheter and patient tube connection setup. No injuries have been reported.

    Product
    Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0319-2024·2023-11-22

    CT Scanner Software Bug May Cause Gantry to Move to Wrong Position

    Philips Spectral CT on Rails software version 5.1.0 may fail to move the needle position to the desired location during scans. This could cause the gantry to move unexpectedly and potentially collide with the user or needle.

    Product
    Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0103-2024·2023-11-22

    DOP Instant Hand Sanitizer Recalled for Potency Compliance Failures

    Omega & Delta Co., Inc. is recalling specific lots of DOP Instant Hand Sanitizer because they do not meet established potency standards. Some batches are sub-potent or super-potent, potentially affecting antimicrobial effectiveness or causing irritation.

    Product
    DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ (118 ml) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00027 4
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0308-2024·2023-11-22

    Laboratory Culture Disks Recalled for Aspergillus Flavus Contamination

    Microbiologics Inc is recalling LYFO-DISK P. venetum laboratory culture disks (lot 794-142) found contaminated with Aspergillus flavus during complaint investigation. The product was distributed worldwide.

    Product
    LYFO-DISK, P. venetum, Catalog number 0794L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0105-2024·2023-11-22

    Equate Hand Sanitizer recalled for potency non-compliance in Puerto Rico

    Equate Hand Sanitizer 7.5 oz bottles (Lot #006511) from Omega & Delta Co., Inc. are being recalled due to potency non-compliance. The product was distributed in Puerto Rico.

    Product
    Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0303-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Loss

    Physio-Control is recalling 8 LIFEPAK 15 defibrillators due to loose battery pins that may cause power loss. Affected units were distributed in Arizona, California, North Carolina, New Jersey, and New York.

    Product
    LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V792000·2023-11-22

    Mack Trucks Recalled for Accelerator Control System Sensor Failure

    Mack is recalling 650 2023–2024 trucks due to a sensor defect that can prevent the engine from returning to idle quickly, risking loss of vehicle control. The company will replace the throttle pedal and update software at no cost.

    Product
    MACK — MACK ANTHEM (AN), TERRAPRO (TE), GRANITE (GR), LR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0314-2024·2023-11-22

    Blood culture kit recalled due to expired internal components

    Medline's blood culture kit is being recalled because components inside the kit have expired before the kit's stated expiration date. This could affect the kit's ability to function properly.

    Product
    BLOOD CULTURE KIT, REF DYNDH1647B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0313-2024·2023-11-22

    Blood Culture Kits Recalled Due to Expired Internal Components

    Medline Industries is recalling 3,160 units of 24 Blood Culture Kits because components within the kit have expired before the overall kit's stated expiration date. Expired components may compromise device performance or test result accuracy.

    Product
    24 BLOOD CULTURE KIT, REF DYNDH1632
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V790000·2023-11-22

    2024 Land Rover Range Rover oil cooler hose recall

    Certain 2024 Land Rover Range Rovers may have improperly secured engine oil cooler hoses that could leak oil onto roadways, creating a hazard for other drivers and increasing crash risk.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V786000·2023-11-22

    2024 Chevrolet Silverado EV Front Seat Belt Buckle Bolts May Not Be Properly Tightened

    General Motors recalls certain 2024 Chevrolet Silverado EV vehicles due to improperly tightened front seat belt buckle attachment bolts that may not restrain occupants properly during a crash.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO EV, HUMMER EV PICKUP, HUMMER EV SUV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V785000·2023-11-22

    Cadillac Lyriq seat belt bracket defect recall for 2023-2024 models

    General Motors is recalling certain 2023-2024 Cadillac Lyriq vehicles because the bracket anchoring the rear seat belts may have been improperly welded. The defect may prevent the seat belts from properly restraining occupants during a crash.

    Product
    CADILLAC — CADILLAC LYRIQ, redundant LYRIQ
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0309-2024·2023-11-22

    Medical Device Reagent Recalled for Unreliable Test Results

    Beckman Coulter's Transferrin reagent lot 2573 does not maintain stability as claimed, causing unreliable patient test results and control failures. The company confirmed the issue affects diagnostic accuracy.

    Product
    AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0299-2024·2023-11-22

    LIFEPAK 15 defibrillator recalled for potential battery power loss

    Physio-Control is recalling 5 LIFEPAK 15 defibrillators due to a potential defect where battery pins may become loose, resulting in power loss. No illnesses or injuries have been reported.

    Product
    LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·24031·2023-11-22

    Lenovo USB-C Laptop Power Banks Recalled for Fire Hazard

    Lenovo is recalling about 2,850 USB-C laptop power banks because internal screws can loosen, causing a short circuit and lithium-ion battery overheating. One fire with minimal property damage has been reported.

    Product
    Lenovo USB-C Laptop Power Banks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0316-2024·2023-11-22

    Ocean Chest Drains Recalled for Inadequate Assembly Instructions

    Atrium Medical recalls Ocean chest drains due to insufficient precaution instructions for proper catheter and tube connection setup. Improper assembly could compromise device function.

    Product
    Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0302-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recalled for Loose Battery Pins Causing Power Loss

    Physio-Control is recalling LIFEPAK 15 defibrillators due to a potential for battery pins to become loose, which could cause power failure.

    Product
    LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0317-2024·2023-11-22

    Oasis Water Seal Chest Drains Recalled for Inadequate Setup Instructions

    Atrium Medical's Oasis Dry Suction Water Seal Chest Drains are recalled because Instructions for Use do not adequately explain proper setup of catheter and patient tube connections on single collection chamber models.

    Product
    Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OASIS BRU W/AC;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0419-2024·2023-11-22

    Amazon Fresh Frosted Mini Brownies recalled for potential plastic contamination

    Amazon Fresh Frosted Mini Brownies (Item 19858) may contain plastic pieces. The 12-count packs distributed nationwide are subject to recall.

    Product
    Item 19858, Amazon Fresh, Frosted Mini Brownie with yellow and purple icing with sprinkles, 12 count per pack, packaged in a plastic clear clamshell container, net wt. 14oz. Case UPC 1 08 42379 19858 5; Retail package UPC 8 42379 19858 8.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0312-2024·2023-11-22

    Medline Recalls Central Line Blood Culture Kits Over Expired Components

    Medline Industries is recalling 1,600 Central Line Blood Culture kits due to component expiration prior to the listed kit expiration date. Expired materials could compromise blood culture test accuracy.

    Product
    CENTRAL LINE BLOOD CULTURE DRA, REF DYNDH1562
    Category
    Medical Device
    Distribution
    Distributed nationwide

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