The Recall Desk

Archive

March 2024 recalls

556 recalls were announced in March 2024.

What the numbers show

Critical
24
Severe
151
High
334
Moderate
45
Low
2

Of the 556 recalls this month scored against our rubric, 4% are Critical, 27% are Severe.

201–300 of 556

  • HighNHTSA·24V200000·2024-03-14

    2022-2024 Kia EV6: Loss of Drive Power from Charging System Failure

    Kia is recalling 2022-2024 EV6 vehicles because the Integrated Charging Control Unit may fail, stopping the 12-volt battery from charging. This loss of drive power increases crash risk.

    Product
    KIA — KIA EV6
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V201000·2024-03-14

    Jaguar E-Pace Brake Pad Warning Light May Not Activate

    Jaguar is recalling certain 2021-2024 E-Pace vehicles because the brake pad wear warning light may not appear when brake pads are worn. This could reduce braking ability and increase crash risk.

    Product
    JAGUAR — JAGUAR E-PACE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V196000·2024-03-14

    Stellantis Recalls 2016 Jeep Wrangler for Air Bag Clockspring Defect

    Stellantis is recalling 2016 right-hand drive Jeep Wranglers because debris may cause the clockspring to fail, preventing the driver's air bag from deploying in a crash.

    Product
    JEEP — JEEP WRANGLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24158·2024-03-14

    Honeywell System Sensor L-Series Fire Alarm Sounders and Strobes Recall

    Honeywell is recalling about 29,000 System Sensor L-Series low frequency fire alarm sounders and strobes because they can malfunction and fail to alert people to a fire. No injuries have been reported, but two units showed low or no sound output during installation.

    Product
    System Sensor L-series low frequency Sounders and Strobes for residential apartments and commercial buildings
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24159·2024-03-14

    Insignia Air Fryers and Ovens Recalled for Fire and Burn Hazards

    Best Buy is recalling about 187,400 Insignia brand air fryers and air fryer ovens sold from November 2021 through November 2023 because the units can overheat, causing handles to melt, glass doors to shatter, and fires.

    Product
    Air Fryers and Air Fryer Ovens
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24161·2024-03-14

    U.S. Boiler Company Recalls Gas-Fired Residential Boilers for Carbon Monoxide Hazard

    About 2,500 U.S. Boiler, New Yorker Boiler, Advantage, FORCE, and Archer brand gas-fired boilers are recalled because the blocked vent switch can fail at altitudes above 5,400 feet, allowing carbon monoxide to accumulate in homes. No injuries have been reported.

    Product
    U.S. Boiler, New Yorker Boiler, Advantage, FORCE and Archer brand gas-fired hot water residential boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·24V197000·2024-03-14

    2022 RAM ProMaster Wiring Harness Causes Left Taillight and Turn Signal Failure

    Chrysler is recalling 2021-2022 RAM ProMaster vehicles due to wiring harness defects that can disable the left taillight and turn signal, increasing crash risk. Dealers will replace the harness free of charge.

    Product
    RAM — RAM PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·24160·2024-03-14

    Tracker Off Road OX EV Light Utility Vehicles Recalled for Fire Hazard

    About 500 Tracker Off Road OX EV vehicles are being recalled due to water entering the lithium-ion battery pack, which can cause a fire. No injuries have been reported.

    Product
    Tracker Off Road OX EV Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1044-2024·2024-03-13

    Vegetarian Pia Cake Taro Durian Recalled for Undeclared Egg Allergen

    LQNN Inc. is recalling Vegetarian Pia Cake Taro Durian (14 oz bags) due to undeclared egg allergen. The recall affects approximately 222,320 bags distributed across 31 U.S. states and Canada.

    Product
    Vegetarian Pia Cake Taro Durian, 14 oz (400g)
    Category
    Food
    Distribution
    32 states
  • CriticalFDA (Food)·F-1050-2024·2024-03-13

    Vegetarian Pia Cake Recalled for Undeclared Egg Allergen

    LQNN Inc. is recalling 222,320 bags of Vegetarian Pia Cake Mung Bean Pineapple for containing undeclared egg. The product was distributed across 31 U.S. states and Canada.

    Product
    Vegetarian Pia Cake Mung Bean Pineapple, 14oz (400g)
    Category
    Food
    Distribution
    32 states
  • CriticalFDA (Food)·F-1035-2024·2024-03-13

    Frios Gourmet Pops Frozen Popsicles Recalled for Undeclared Egg Allergen

    Frios Gourmet Pops frozen popsicles are being recalled because they contain undeclared egg, an allergen. Consumers with egg allergies may face allergic reactions if they consume these products.

    Product
    Frios Gourmet Pops - Banana Pudding Popsicle 3oz frozen popsicle packaged individually in clear plastic sleeve. 48 popsicles per box. *Sold directly to end consumer via food truck
    Category
    Food
    Distribution
    17 states
  • SevereFDA (Food)·F-1047-2024·2024-03-13

    FDA recalls Banh Pia Classic Hopia for undeclared egg allergen

    LQNN Inc. is recalling Banh Pia Classic Hopia because it contains undeclared egg allergen, which can cause serious allergic reactions. About 222,320 bags were distributed across 31 U.S. states and Canada.

    Product
    Banh Pia Classic Hopia, Mung Bean Durian, 16.8oz (480g)
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Food)·F-1040-2024·2024-03-13

    Chick-fil-A Polynesian Sauce Cup recalled for undeclared wheat and soy allergens

    T Marzetti Co is recalling Chick-fil-A Polynesian Sauce Cups (28g single serve) due to undeclared wheat and soy allergens. The product was distributed across 11 U.S. states.

    Product
    Chick-fil-a Polynesian Sauce Cup: 28g single serve food service cup
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-1052-2024·2024-03-13

    Vegetarian Pia Cake Recalled for Undeclared Egg Allergen

    LQNN Inc. is recalling Vegetarian Pia Cake Red Bean Durian products due to undeclared egg allergen. The recall affects 222,320 bags distributed across 31 U.S. states and Canada.

    Product
    Vegetarian Pia Cake Red Bean Durian, 14oz (400g)
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Devices)·Z-1187-2024·2024-03-13

    Avanos Medical recalls MIC gastric-jejunal feeding tubes with defective syringe

    Avanos Medical is recalling MIC Gastric-Jejunal Feeding Tube Kits containing a sterile pre-filled syringe that was recalled by Nurse Assist. Approximately 53,126 units were distributed worldwide.

    Product
    MIC* Gastric-Jejunal Feeding Tube, Endoscopic/Radiologic Placement, GJ-Tube: a) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Code 0250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit - Endoscopic/Radiologic Placement - 16 Fr, Product Co
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1028-2024·2024-03-13

    Cheese Enchiladas Recalled Due to Potential Listeria Monocytogenes Contamination

    The Fierro Group Inc. is recalling cheese enchiladas with green sauce due to potential Listeria monocytogenes contamination. Products were distributed to supermarkets in Utah.

    Product
    Cheese Enchiladas with Green sauce 4/pkg 14.5oz packaged in a in a Deep Meal tray Plant Fiber - Film 800.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1041-2024·2024-03-13

    Harissa hummus recalled for undeclared sesame allergen

    Wegmans Harissa Hummus (10.5 oz) is recalled because it contains undeclared sesame, an allergen. Consumers with sesame allergies who have purchased affected lots should not consume the product.

    Product
    Wegmans Harissa Hummus Topped With Harrisa 10.5 ounce (298 g), clear plastic package with top, side and bottom labels.
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Food)·F-1043-2024·2024-03-13

    Vegetarian Pia Cake Mung Bean Pumpkin Recalled for Undeclared Egg Allergen

    LQNN Inc. is recalling 222,320 bags of Vegetarian Pia Cake Mung Bean Pumpkin because the product contains undeclared egg allergen. Consumers with egg allergies should not eat this product.

    Product
    Vegetarian Pia Cake Mung Bean Pumpkin, 14 oz (400g)
    Category
    Food
    Distribution
    32 states
  • SevereNHTSA·24V195000·2024-03-13

    Cushman Hauler Pro LSV Recalled for Battery Fire Risk

    Textron is recalling 2024 Cushman Hauler Pro LSV vehicles because a dump bed latch may crack or puncture the battery case, increasing the risk of a fire.

    Product
    CUSHMAN — CUSHMAN HAULER PRO LSV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1186-2024·2024-03-13

    MIC Gastric-Jejunal Feeding Tube Kits Recalled Over Defective Syringe

    Avanos Medical is recalling MIC Gastric-Jejunal Feeding Tube Kits because they contain a sterile pre-filled syringe that was subsequently recalled by Nurse Assist. Approximately 10,808 units have been distributed worldwide.

    Product
    MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Placement - 16 Fr, Product Code 8250-16; b) MIC* Gastric-Jejunal Feeding Tube Kit with ENFit Connector - Endoscopic/Radiologic Pla
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1039-2024·2024-03-13

    Classic Castle Shredded Three Cheese Blend Recalled for Listeria Risk

    Classic Castle Brand Shredded Three Cheese Blend has been recalled due to potential contamination with Listeria monocytogenes. Consumers should not consume affected products.

    Product
    Classic Castle Brand Shredded Three Cheese Blend Net Wt. 20 Lbs, Net Wt. 5 lbs. Fontana, CA 92336 Plant #06-00333
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-1024-2024·2024-03-13

    Golden Owl Dried Mango Recall for Undeclared Sulfites

    Golden Owl Dried Mango (7 oz) is recalled due to undeclared sulfites. Consumers with sulfite sensitivity should not consume this product.

    Product
    Golden Owl Dried Mango 7 oz (200g) UPC 816710-024461. Packaged in clear non-flex plastic jars. 24 jars per case.
    Category
    Food
    Distribution
    17 states
  • SevereFDA (Food)·F-1029-2024·2024-03-13

    Chicken Enchilada with Rice & Beans Recalled for Listeria Contamination

    The Fierro Group Inc. is recalling Chicken Enchilada with Rice & Beans products due to potential Listeria monocytogenes contamination in the Queso Fresno cheese. Affected products were distributed to supermarkets in Utah.

    Product
    Chicken Enchilada with Rice & Beans/Green 14 oz. packaged in a in a Deep Meal tray Plant Fiber - Film 800.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1042-2024·2024-03-13

    BANH PIA Hopia Cake Recalled Due to Undeclared Egg Allergen

    LQNN Inc. is recalling BANH PIA Hopia Cake due to undeclared egg allergen. Approximately 222,320 bags were distributed to 31 U.S. states and Canada.

    Product
    BANH PIA Hopia Cake, Mung Bean - Durian, 16.8 oz (480g)
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Food)·F-1026-2024·2024-03-13

    Taylor Fresh Foods Roasted Street Corn Salad Recalled for Listeria Contamination Risk

    Taylor Fresh Foods recalls COLD CASE roasted street corn salad due to potential Listeria monocytogenes contamination. Affected: 60 cases across 28 states.

    Product
    COLD CASE, ROASTED STREET CORN SALAD 1/4.78# (KR) Separate Kit Items packed in sealed bag and placed in a plastic RPC container
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Food)·F-1027-2024·2024-03-13

    Cheese Enchiladas Recalled for Potential Listeria Monocytogenes Contamination

    The Fierro Group Inc. is recalling Cheese Enchiladas with Red sauce due to potential contamination with Listeria monocytogenes. Products were distributed to supermarkets in Utah.

    Product
    Cheese Enchiladas with Red sauce 4/pkg 14.5oz packaged in a in a Deep Meal tray Plant Fiber - Film 800.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1048-2024·2024-03-13

    BANH PIA Hopia Cake Recalled for Undeclared Egg Allergen

    LQNN Inc. is recalling BANH PIA Hopia Cake Mungbean Durian due to undeclared egg allergen. The product was distributed to customers in 31 U.S. states and Canada.

    Product
    BANH PIA Hopia Cake Mungbean Durian, 9.7oz (275g)
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Food)·F-1046-2024·2024-03-13

    Vegetarian Pia Cake Recalled for Undeclared Egg Allergen

    LQNN Inc. is recalling approximately 222,320 bags of Vegetarian Pia Cake Black Sesame Durian due to undeclared egg. Consumers with egg allergies should not consume this product.

    Product
    Vegetarian Pia Cake Black Sesame Durian, 14oz (400g)
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Food)·F-1051-2024·2024-03-13

    Vegetarian Pia Cake Pandan Durian Recalled for Undeclared Egg Allergen

    LQNN Inc. is recalling 222,320 bags of Vegetarian Pia Cake Pandan Durian due to undeclared egg allergen. Consumers with egg allergies should not consume this product.

    Product
    Vegetarian Pia Cake Pandan Durian, 14oz (400g)
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Food)·F-1025-2024·2024-03-13

    Taylor Fresh Foods Marketside Salad Kit Recalled for Potential Listeria Contamination

    Taylor Fresh Foods is recalling Marketside Bacon Ranch Crunch Chopped Salad Kits due to potential Listeria monocytogenes contamination. Affected products with best-by dates on or before Feb 21, 2024 were distributed to 28 states.

    Product
    Marketside Bacon Ranch Crunch Chopped Salad Kit 12.76oz UPC 681131305440
    Category
    Food
    Distribution
    27 states
  • SevereFDA (Food)·F-1049-2024·2024-03-13

    Vegetarian Pia Cake Recalled Due to Undeclared Egg Allergen

    LQNN Inc. is recalling Vegetarian Pia Cake Mungbean Durian (14oz) distributed across 31 U.S. states and Canada due to undeclared egg allergen, which poses serious risk to consumers with egg allergies.

    Product
    Vegetarian Pia Cake Mungbean Durian, 14oz (400g)
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Food)·F-1053-2024·2024-03-13

    BANH PIA Pumpkin Pia Cake Recalled for Undeclared Egg Allergen

    BANH PIA Liu Sha Pumpkin Pia Cake is recalled because it contains egg that is not declared on the label. The recall affects 222,320 bags distributed across 31 US states and Canada. Consumers with egg allergies should not consume this product.

    Product
    BANH PIA Liu Sha Pumpkin Pia Cake, 480g
    Category
    Food
    Distribution
    32 states
  • SevereFDA (Food)·F-1038-2024·2024-03-13

    Castle Importing Cotija Cheese Recalled for Potential Listeria Contamination

    Castle Importing is recalling crumbled and grated Cotija cheese due to potential Listeria monocytogenes contamination. The affected products were distributed to retailers in California, Ohio, Connecticut, Florida, Texas, Washington, and Illinois.

    Product
    Crumbled Cotija Net Wt. 5.6 lbs (300/0.3oz), Net Wt. 7.5 lbs (300/0.4 oz) Fontana, CA 92336 Plant #06-00333 Classic Castle Brand Crumbled Cotija Net Wt. 20 lbs, Net Wt. 5 lbs Fontana, CA 92336 Plant #06-00333 Classic Castle Brand Grated Cotija Net Wt. 20 lbs, Net Wt. 5 lbs Font
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-1030-2024·2024-03-13

    Chicken Enchilada Recall: Listeria Risk from Queso Fresno Cheese

    The Fierro Group Inc. (Rico Brands) is recalling Chicken Enchilada with Mole Rice & Beans due to potential Listeria monocytogenes contamination in the Queso Fresno cheese. Affected products were distributed to supermarkets in Utah.

    Product
    Chicken Enchilada with Mole Rice & Beans 14 oz. packaged in a in a Deep Meal tray with Plant Fiber - Film 800.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1222-2024·2024-03-13

    VITROS XT7600 System Aspiration Risk During Sample Processing

    Ortho-Clinical Diagnostics is recalling the VITROS XT7600 Integrated System due to potential aspiration from unintended sample containers during processing, which may result in erroneous test results. The recall affects 1,720 units distributed worldwide.

    Product
    VITROS XT7600 Integrated System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1220-2024·2024-03-13

    VITROS 3600 Immunodiagnostic Systems May Cause Aspiration During Sample Processing

    The VITROS 3600 Immunodiagnostic System is being recalled due to potential aspiration of sample containers during laboratory processing, which may result in erroneous test results.

    Product
    VITROS 3600 Immunodiagnostic System (New and Refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1259-2024·2024-03-13

    X3 Triathlon CS Insert Recalled for Potential Sterile Packaging Breach

    Howmedica Osteonics Corp. is recalling the X3 Triathlon CS Insert due to potential breaches in the inner and outer sterile packaging. The breaches could compromise device sterility, affecting 132 units in the U.S. and 26 internationally.

    Product
    X3 TRIATHLON CS INSERT NO 3 10 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1233-2024·2024-03-13

    VITROS Diagnostic System Software Defect May Cause Erroneous Patient Results

    Ortho-Clinical Diagnostics is recalling VITROS XT 7600 systems with software defects in versions 3.8.0 and 3.8.1. The defect prevents quality control rules from being properly reported, which could cause erroneous patient test results.

    Product
    VITROS XT 7600 Integrated System, Catalog No. 6844461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1224-2024·2024-03-13

    Medical Device: VITROS 3600 immunodiagnostic system software defect may produce incorrect results

    A software defect in the VITROS 3600 Immunodiagnostic System may cause quality control baseline statistics to fail to update properly, potentially resulting in erroneous patient test results.

    Product
    VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1250-2024·2024-03-13

    MRI System Spatial Field Gradient Values Incorrectly Displayed and Documented

    Vantage Titan MRI systems display and document spatial field gradient values that are lower than correct, which may cause discomfort in patients with MR-conditional devices.

    Product
    Vantage Titan, Model: MRT-1504
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1255-2024·2024-03-13

    Paragon 28 Phantom TTC Nail recalled for unsterilized distribution

    Paragon 28, Inc. is recalling the Phantom TTC Nail (10.0 X 150mm, RIGHT) distributed in California, as these devices were shipped prior to sterilization. Unsterilized surgical implants pose a serious risk of infection and complications.

    Product
    Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1230-2024·2024-03-13

    VITROS 4600 Chemistry System Software Defect Affects Quality Control Reporting

    A software defect in VITROS 4600 Chemistry Systems running software versions 3.8.0 or 3.8.1 prevents quality control rules from being flagged or reported correctly, potentially allowing erroneous patient results to be released.

    Product
    VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2024·2024-03-13

    Synthes RIA Tube Assembly Recalled for Unconfirmed Sterility

    Synthes is recalling 144 units of RIA Tube Assembly surgical instruments due to sterility failure. The devices cannot be confirmed as sterile and pose a risk of infection if used in orthopedic procedures.

    Product
    RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis, to harves
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1225-2024·2024-03-13

    Laboratory analyzer software defect may cause erroneous patient test results

    A software defect in VITROS 4600 Chemistry Systems causes quality control baselines to not update when users change them, potentially causing erroneous patient results.

    Product
    VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1232-2024·2024-03-13

    Laboratory chemistry system software defect impairs quality control reporting

    A software defect in VITROS XT 3400 Chemistry Systems prevents quality control rules from properly reporting failures in test controls. This may result in erroneous patient test results being reported.

    Product
    VITROS XT 3400 Chemistry System, Catalog No. 6844458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1226-2024·2024-03-13

    VITROS 5600 Diagnostic System Software Defect May Cause Erroneous Lab Results

    A software defect in VITROS 5600 Systems prevents quality control baseline statistics from updating properly, which may cause erroneous patient test results to be reported.

    Product
    VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1231-2024·2024-03-13

    VITROS 5600 Diagnostic System Software Defect Prevents Quality Control Flagging

    Ortho-Clinical Diagnostics is recalling VITROS 5600 diagnostic systems (software versions 3.8.0 or 3.8.1) due to a defect that prevents quality control alerts from displaying, potentially allowing erroneous patient test results to be reported.

    Product
    VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1238-2024·2024-03-13

    RAPIDSORB IPS Battery Pack recalled due to unconfirmed sterility

    Synthes is recalling 10 units of RAPIDSORB IPS Battery Pack Sterile because the products cannot be confirmed as sterile. The affected lot was distributed worldwide to medical facilities. Patients should consult their healthcare provider about replacement options.

    Product
    RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. Part Number: 530.553.01S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1239-2024·2024-03-13

    TFNA Femoral Nail surgical implant recalled for sterility failure

    Synthes (USA) Products LLC is recalling 11 TFNA Femoral Nails (Lot 3744P37) because the products are not sterilized or sterility cannot be confirmed, posing infection risk.

    Product
    TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.944S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1260-2024·2024-03-13

    X3 Triathlon Orthopedic Insert Recalled Due to Potential Packaging Breaches

    Howmedica Osteonics recalls 143 units of the X3 Triathlon CS Insert No. 6 (10 mm) due to potential breaches in inner and outer sterile blister packaging that could compromise product sterility.

    Product
    X3 TRIATHLON CS INSERT NO 6 10 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1229-2024·2024-03-13

    Medical Device Software Defect May Cause Erroneous Lab Results

    A software defect in VITROS 3600 Immunodiagnostic Systems (versions 3.8.0 and 3.8.1) prevents quality control rules from reporting failures as expected, potentially allowing invalid test results to be reported.

    Product
    VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1023-2024·2024-03-13

    Frothy Monkey Spinach and Feta Croissants Recalled for Metal Fragments

    Bakery by Frothy Monkey is recalling Spinach & Feta Croissants sold in Tennessee and Alabama due to potential metal fragments. Consumers should not eat these croissants and should return them to the store.

    Product
    Frothy Monkey - Spinach & Feta Croissant - packaged and sold individually
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1247-2024·2024-03-13

    Aesculap Hasson Trocar Recall Due to Potentially Compromised Sterile Packaging

    Aesculap Inc recalls Disposable Hasson Trocars (EK240SU) due to potentially damaged sterile packaging that may compromise sterility. Batch 52581648 distributed in KS, NJ, NY, and Canada requires immediate discontinuation.

    Product
    DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1022-2024·2024-03-13

    Frothy Monkey Ham & Cheese Croissant Recalled for Potential Metal Fragments

    Bakery by Frothy Monkey is recalling Ham & Cheese Croissants due to potential metal fragments in the product. Consumers should not consume affected units.

    Product
    Frothy Monkey - Ham & Cheese Croissant - packaged and sold individually
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1234-2024·2024-03-13

    Titanium Hindfoot Arthrodesis Cannulated Nails Recalled Due to Sterilization Failure

    Synthes recalls 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails (5 units) due to failed sterilization. These surgical implants were distributed worldwide and pose infection risk if implanted.

    Product
    13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to facilitate tibiotalocalcaneal arthrodesis to treat severe foot/ankle deformity, arthritis, instability, and skeletal defects after tumor resection. Part Number: 04.008.378S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1271-2024·2024-03-13

    FUJIFILM Synapse PACS Software Produces Incorrect Breast Imaging Measurements

    FUJIFILM is recalling Synapse PACS Version 7.2.100 because the medical imaging software produces incorrect measurements when analyzing certain breast images. Affected healthcare facilities using this software version should verify measurement accuracy in their systems.

    Product
    Synapse PACS - Version 7.2.100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1241-2024·2024-03-13

    Synthes Clavicle Plate Implants Recalled Due to Sterility Failure

    Synthes is recalling 47 VA-LCP Clavicle Plate 2.7 bone fixation implants (Lot 1201P12) distributed worldwide because sterility cannot be confirmed. Non-sterile surgical implants pose risk of infection.

    Product
    VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicle bone fragments. Part Number: 02.112.621S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1261-2024·2024-03-13

    X3 Triathlon inserts recalled for potential sterile packaging breaches

    Howmedica Osteonics Corp. is recalling X3 Triathlon inserts due to potential breaches in sterile packaging. The breach could compromise device sterility and allow contamination if the affected units are used.

    Product
    X3 TRIATHLON CS INSERT NO 6 11 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2024·2024-03-13

    Synthes 1.5MM Surgical Drill Bit Recalled Due to Sterilization Concerns

    Synthes has recalled 17 units of 1.5MM surgical drill bits worldwide because the products could not be confirmed as sterilized, posing an infection risk during orthopedic procedures.

    Product
    1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1253-2024·2024-03-13

    Apollo Onyx Delivery Microcatheter recalled for incorrect indications for use

    Micro Therapeutics is recalling Apollo Onyx Delivery Microcatheter devices with incorrect indications for use. European-version devices were distributed in the U.S. across 29 states.

    Product
    The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1251-2024·2024-03-13

    Invacare Homecare and G-Series Bed Components Recalled for Weld Defects

    Invacare Corporation is recalling approximately 8,117 bed component units nationwide due to a potential weld defect that may cause premature weld failure.

    Product
    Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5) BAR5000IVC (6) 5000IVC (7) 5490IVC (8) 5490LOW
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1272-2024·2024-03-13

    Medical imaging software measurements incorrect in specific cases

    FUJIFILM's Synapse PACS Version 7.2.200 produces incorrect measurements when analyzing certain breast imaging scans without pixel spacing data. This measurement error could affect diagnostic accuracy.

    Product
    Synapse PACS - Version 7.2.200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1243-2024·2024-03-13

    Aesculap Disposable Trocar with Dilating Pin Recalled for Compromised Sterility

    Aesculap Inc is recalling Disposable Trocars with Dilating Pins (Product Code EK224SU) due to potentially damaged sterile blister packaging that may compromise sterility. Affected units were distributed in the US and Canada.

    Product
    DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1236-2024·2024-03-13

    Synthes 2.5MM Surgical Drill Bits Recalled Due to Unconfirmed Sterility

    Synthes (USA) Products LLC is recalling 30 units of 2.5MM sterile surgical drill bits (Lot 77P6506) because sterility cannot be confirmed. Non-sterile surgical instruments pose a risk of surgical site infection if used in orthopedic procedures.

    Product
    2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1245-2024·2024-03-13

    Aesculap Disposable Trocars Recalled Due to Sterile Packaging Damage Risk

    Aesculap Inc is recalling disposable trocars with dilating pins (Product Code EK234SU) because their sterile blister packaging may be damaged, potentially compromising sterility. This Class II recall affects units distributed in the US and Canada.

    Product
    DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1034-2024·2024-03-13

    Lian Sheng Dried Plum Recalled Due to Undeclared Sulfites

    Lian Sheng Dried Plum is recalled due to undeclared sulfites. The product contains 21.91 mg/serving of sulfites that are not listed on the label, posing a risk to people with sulfite sensitivity.

    Product
    Lian Sheng Dried Plum; 5.8oz (165g); packaged in clear plastic bottle; UPC 6928580581396
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1240-2024·2024-03-13

    TFNA Femoral Nail Recalled Due to Sterility Confirmation Issue

    Synthes is recalling 11 TFNA Femoral Nails due to sterility failures. The affected units worldwide cannot be confirmed as sterilized and pose infection risks to patients.

    Product
    TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.144S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1033-2024·2024-03-13

    Dried Tangerine Plum Recalled Due to Undeclared Sulfites

    Rong Shing Trading NY Inc is recalling 4.7oz bottles of Dried Tangerine Plum due to undeclared sulfites. Products distributed in Florida and New York with best-before date 05/31/2023 may be affected.

    Product
    Dried Tangerine Plum; packaged in 4.7oz (135g) clear plastic bottle; UPC 6928580580214
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1269-2024·2024-03-13

    Medical Device Imaging Software May Calculate Incorrect Breast Measurements

    Synapse PACS Version 7.1.000US may produce incorrect measurements when Secondary Capture 2D images lack pixel spacing information in the DICOM header. The affected software is installed in healthcare facilities worldwide, including the United States and Puerto Rico.

    Product
    Synapse PACS - Version 7.1.000US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1256-2024·2024-03-13

    Paragon 28 Phantom TTC Nail Recalled Due to Improper Sterilization

    Paragon 28 has recalled the Phantom TTC Nail (11.5 X 250mm, RIGHT, REF: P31-615-250R) distributed in California prior to sterilization. Non-sterilized surgical implants pose a risk of infection.

    Product
    Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1273-2024·2024-03-13

    Synapse PACS version 7.3.000 produces incorrect breast imaging measurements

    FUJIFILM's Synapse PACS version 7.3.000 software produces incorrect measurements when secondary capture images without pixel spacing are combined with breast tomosynthesis series. No illnesses or injuries reported.

    Product
    Synapse PACS - Version 7.3.000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1045-2024·2024-03-13

    BANH Ba Xa Lady Cake Recalled for Undeclared Egg Allergen

    BANH Ba Xa Lady Cake (260g) was recalled due to undeclared egg allergen. Approximately 222,320 bags distributed across 31 U.S. states may pose risk to egg-allergic consumers.

    Product
    BANH Ba Xa Lady Cake, 260g
    Category
    Food
    Distribution
    32 states
  • HighFDA (Devices)·Z-1246-2024·2024-03-13

    Aesculap Disposable Trocars with Dilating Pins Recalled for Packaging Damage

    Aesculap Inc is recalling disposable trocars with dilating pins due to potential sterile blister packaging damage that may compromise sterility. The affected product (code EK236SU) was distributed in the US and Canada.

    Product
    DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1020-2024·2024-03-13

    Frothy Monkey Plain Croissants recalled for potential metal fragments

    Bakery by Frothy Monkey is recalling individually packaged Plain Croissants distributed in Tennessee and Alabama (Best By 01/31/2024) due to potential metal fragments.

    Product
    Frothy Monkey - Plain Croissant - packaged and sold individually
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1252-2024·2024-03-13

    FDA Recalls Apollo Onyx Delivery Microcatheter Due to Labeling Mismatch

    FDA is recalling Apollo Onyx Delivery Microcatheters distributed in the US with incorrect European labeling. The devices contain different indications for use than those approved for the US market.

    Product
    The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the infusion of the Onyx liquid embolic system (LES). The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·013-2024·2024-03-13

    Kroger Apple Walnut Chicken Salad Bowl Recalled for Undeclared Wheat

    Taylor Farms Pacific is recalling Kroger brand apple walnut with chicken salad bowls due to undeclared wheat allergen. No adverse reactions have been reported.

    Product
    Taylor Farm - Pacific — Taylor Farms Pacific Recalls Kroger Brand Ready-To-Eat Apple Walnut With Chicken Salad Bowl Products Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-1254-2024·2024-03-13

    Paragon 28 Phantom TTC Nail distributed prior to sterilization

    Paragon 28 is recalling Phantom TTC Nails distributed before sterilization. Non-sterile surgical devices pose a potential infection risk if implanted.

    Product
    Phantom TTC Nail, 10.0 X 200mm, Right
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1036-2024·2024-03-13

    Frios Gourmet Pops Creamy Coconut recalled for undeclared sulfites

    FGP Manufacturing recalls Frios Gourmet Pops due to undeclared sulfites in frozen popsicles distributed to franchise owners across 17 states. Consumers with sulfite sensitivity should not consume the product.

    Product
    Frios Gourmet Pops - Creamy Coconut Popsicle 3oz frozen popsicle packaged individually in clear plastic sleeve. 48 popsicles per box. *Sold directly to end consumer via food truck
    Category
    Food
    Distribution
    17 states
  • HighFDA (Devices)·Z-1265-2024·2024-03-13

    FDA Recalls Tibial Inserts Due to Potential Sterile Packaging Breach

    Howmedica Osteonics is recalling tibial inserts due to potential breaches in sterile packaging. The breach could allow device contamination and increase post-operative infection risk.

    Product
    NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1021-2024·2024-03-13

    Frothy Monkey Chocolate Croissants Recalled for Potential Metal Fragments

    Bakery by Frothy Monkey is recalling chocolate croissants due to the potential presence of metal fragments. The affected products were distributed in Tennessee and Alabama.

    Product
    Frothy Monkey - Chocolate Croissant - packaged and sold individually
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1266-2024·2024-03-13

    Knee Implant Tibial Inserts Recalled for Sterile Packaging Breach

    Howmedica Osteonics recalls Triathlon knee implant tibial inserts (37 US units) due to potential packaging breaches of inner and outer sterile blisters that may compromise product sterility.

    Product
    NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1262-2024·2024-03-13

    Howmedica X3 Triathlon CS Insert Recalled for Packaging Defects

    Howmedica Osteonics Corp. is recalling the X3 Triathlon CS Insert (Part No. 5531-G-709-E, Lot KA1Y71) due to potential inner and outer sterile blister packaging breaches. No injuries have been reported.

    Product
    X3 TRIATHLON CS INSERT NO 7 9 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1263-2024·2024-03-13

    Orthopedic knee implant recalled for potential sterile packaging breaches

    Howmedica Osteonics Corp. is recalling the NO 3 Triathlon TS Plus Tibial Insert due to potential breaches in the sterile packaging. The breaches could compromise product sterility and safety.

    Product
    NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1242-2024·2024-03-13

    Synthes Opal Intervertebral Cage Spinal Implant Recall: Sterility Not Confirmed

    Synthes is recalling 30 Opal intervertebral cage spinal implants (Lot 427P153) because sterility cannot be confirmed. Patients with these devices should contact their surgeon immediately.

    Product
    Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1276-2024·2024-03-13

    ConvaTec Natura Stomahesive surgical ostomy system pouch-flange coupling mismatch

    ConvaTec Natura Stomahesive ostomy kits contain a 45mm flange but 57mm pouch, creating an incompatible coupling. The mismatch prevents the components from fitting together properly.

    Product
    ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1223-2024·2024-03-13

    Automated medication dispensing cabinets may randomly freeze, crash, or hang

    BD Pyxis automated dispensing cabinets with affected software may randomly hang, freeze, or crash, potentially delaying medication access and causing data loss. Approximately 20,443 units are affected worldwide.

    Product
    BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1270-2024·2024-03-13

    Synapse PACS Software Version 7.2.000 Measurement Error in Breast Imaging

    FUJIFILM's Synapse PACS Version 7.2.000 produces incorrect measurements in breast imaging when analyzing Secondary Capture 2D images lacking pixel spacing information. Affected healthcare facilities should discontinue use for breast imaging measurements.

    Product
    Synapse PACS - Version 7.2.000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1244-2024·2024-03-13

    Aesculap Hasson trocar recalled due to sterility packaging concerns

    Aesculap Inc has recalled Hasson trocar surgical instruments (18 units) because sterile blister packaging may be damaged and sterility compromised. The recall affects the U.S. (Kansas, New Jersey, New York) and Canada.

    Product
    DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1264-2024·2024-03-13

    Triathlon TS Plus tibial inserts recalled for potential packaging breaches

    Howmedica Osteonics Corp. is recalling Triathlon TS Plus tibial inserts due to potential breaches in sterile packaging that could compromise product sterility. Affected units were distributed nationwide and internationally.

    Product
    NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1228-2024·2024-03-13

    Medical device software defect may cause incorrect laboratory test results

    A software defect in VITROS XT 7600 diagnostic systems running version 3.8.1 causes quality control baseline statistics to fail to update properly, potentially resulting in erroneous patient laboratory results.

    Product
    VITROS XT 7600 Integrated System, Catalog No. 6844461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1249-2024·2024-03-13

    MRI System Displays Incorrect Field Gradient Safety Values

    Canon Medical's Vantage Elan MRI system may display incorrect maximum Spatial Field Gradient values, potentially causing discomfort in patients with MR conditional devices.

    Product
    MRI system: Vantage Elan, Model: MRT-2020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1227-2024·2024-03-13

    Medical Device Recall: VITROS XT 3400 Chemistry System Software Defect

    Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to a software defect affecting quality control baseline statistics, which may cause inaccurate patient test results.

    Product
    VITROS XT 3400 Chemistry System, Catalog No. 6844458
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0365-2024·2024-03-13

    Clindamycin Phosphate Topical Solution recalled due to defective container leakage

    Contract Pharmaceuticals Limited Canada is recalling Clindamycin Phosphate Topical Solution 1% due to defective containers with slow leakage. Lot 119874 (expires 06/30/2025) distributed nationwide in the U.S. and Puerto Rico is affected.

    Product
    Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, L5N 6R8, NDC 71428-0003-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0366-2024·2024-03-13

    Methylprednisolone Acetate Injectable Suspension Recalled for Failed Dissolution

    Eugia US LLC recalls methylprednisolone acetate injection due to failed dissolution specifications. Affected states: Ohio, Tennessee, Louisiana, and Mississippi.

    Product
    METHYLPREDNISOLONE ACETATE — METHYLPREDNISOLONE ACETATE (METHYLPREDNISOLONE ACETATE)
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1258-2024·2024-03-13

    Embrace Drill Tower Surgical Instruments Recalled Due to Mixed-Up Type Descriptions

    Waldemar Link recalled Embrace Drill Tower surgical instruments because type descriptions ("standard" vs "wedged") are mixed up in the product overview documentation. Surgeons may select incorrect instrument types due to the confusion.

    Product
    Embrace Drill Tower, Standard/Lateral (25mm)
    Category
    Medical Device
    Distribution
    Distributed nationwide

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