The Recall Desk

Archive

December 2023 recalls

600 recalls were announced in December 2023.

What the numbers show

Critical
29
Severe
213
High
307
Moderate
49
Low
2

Of the 600 recalls this month scored against our rubric, 5% are Critical, 36% are Severe.

301–400 of 600

  • HighFDA (Food)·F-0661-2024·2023-12-20

    Gaw's Salami & Cheese Bagel recalled for undeclared sesame allergen

    Gaws Gourmet Foods is recalling Gaw's Salami & Cheese Bagel 6oz due to undeclared sesame allergen. Affected products have use-by dates from November 28 through December 15, 2023.

    Product
    Gaw's Salami & Cheese Bagel 6oz, Foam Tray with Clear Plastic Wrap package, UPC:1725600501
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0547-2024·2023-12-20

    Laboratory Diagnostic System Software Malfunction Causes System Freezes and Delays

    Ortho-Clinical Diagnostics recalls 216 VITROS XT 7600 laboratory systems running Software Version 3.8.0 due to software issues causing screen freezes and unresponsiveness. The defects delay test result reporting and could postpone patient treatment.

    Product
    VITROS XT 7600 Integrated System Product Code 6844461 Running Software Version 3.8.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0534-2024·2023-12-20

    Medline Leg Bags Recalled Due to Undeclared Latex

    Medline Industries has recalled approximately 19,406 leg bags due to undeclared latex. Patients with latex allergies may experience allergic reactions from skin contact with the device.

    Product
    Medline Leg bag, REF DYND12578
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0546-2024·2023-12-20

    Chemistry System Software Malfunction Causes Freezes and Result Reporting Delays

    Ortho-Clinical Diagnostics is recalling VITROS XT 3400 Chemistry Systems due to software issues causing screen freezes and system unresponsiveness. The problems can delay reporting of patient test results, including critical or STAT assays.

    Product
    VITROS XT 3400 Chemistry System Product Code 6844458 Running Software Version 3.8.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0530-2024·2023-12-20

    Non-sterile Betadine solution labeled and distributed as sterile

    Medline Industries is recalling 1,800 units of Sterile Betadine (Ref DYNDA1998) because the foil sachet contents are non-sterile, despite labeling that claims sterility. The recall affects units nationwide in eight states.

    Product
    STERILE BETADINE, REF DYNDA1998
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0521-2024·2023-12-20

    Cardinal Health Stool Transportation System Recalled for Vial Leakage

    Meridian Bioscience is recalling the Cardinal Health Clean Stool Transportation System due to a manufacturing defect that may cause Para-Pak vials to leak. Affected product: 38 cases with Lot Number 510020Q, distributed nationwide and to Italy.

    Product
    Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0573-2024·2023-12-20

    Frozen and Refrigerated Cheese Products Recalled Due to Temperature Abuse

    Ben E Keith Foods - Fort Worth is recalling frozen and refrigerated cheese products that were subjected to temperature abuse during storage and transport.

    Product
    CHEESE VELVEETA LOAF; CHEESE CHEDDAR SLICE MILD; CHEESE STICK MOZZ BATTERED; CHEESE CHEDDAR SLICE MILD
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0517-2024·2023-12-20

    Brachytherapy Treatment Planning Software Recalled Due to Measurement Inaccuracy

    SagiPlan 2.2 brachytherapy treatment planning software is recalled due to a software malfunction that may round numerical values, potentially causing inaccurate treatment measurements.

    Product
    SagiPlan 2.2, CE0344, Rx Only , Brachyterapy Treatment Planning System
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0602-2024·2023-12-20

    Deli Club Sandwich Recalled Due to Inaccurate Label Information

    E.A. Sween Co. is recalling Deli Express Deli Club sandwiches (lot U023236) due to label mix-up with inaccurate required label information. The recall affects 31,550 units distributed across 19 states.

    Product
    Deli Express, Deli Club 4.4oz wedge sandwich, 10 retail units per wholesale case, UPC 41433-00157
    Category
    Food
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0509-2024·2023-12-20

    Spectranetics Turbo-Elite Atherectomy Catheters recalled due to labeling mismatch

    Spectranetics Corporation is recalling 1,239 Turbo-Elite Laser Atherectomy Catheters due to incorrect labeling where the exterior product box label does not match the internal pouch label.

    Product
    Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 OTW REF 420-006 Spectranetics Turbo-Elite Laser Atherectomy Catheter 1.4 RX REF 414-159 Spectranetics Turbo-Elite Laser Atherectomy Catheter…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0506-2024·2023-12-20

    Hungry Root Marinara Sauce recalled for yeast and mold contamination

    BC Gourmet USA, Inc. is recalling 81,312 units of Hungry Root Marinara Sauce due to yeast and mold contamination. Affected products were distributed in California, New Jersey, and Indiana.

    Product
    Hungry Root Marinara Sauce; 10.5 oz Plastic Cup; UPC 81006252077
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-0572-2024·2023-12-20

    Frozen and Refrigerated Foods Recalled Due to Temperature Abuse

    Ben E Keith Foods recalls approximately 1,721 cases of frozen and refrigerated food products due to temperature abuse during distribution to food services.

    Product
    MILK HOMO GALLON
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0576-2024·2023-12-20

    Frozen Bread Products Recalled Due to Temperature Abuse During Shipment

    Ben E Keith Foods recalls 1721 cases of frozen bread products that experienced temperature abuse during truck shipment to food services. Products include sandwich bread, dinner rolls, and hamburger buns.

    Product
    BREAD SANDWICH WHITE LOAF, ROLL DINNER HAWAIIAN, BUN HAMBURGER WHITE 4.5 IN FZN
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0150-2024·2023-12-20

    Liothyronine Sodium tablets recalled due to failed impurity and degradation specifications

    Sun Pharmaceutical is recalling 96,192 bottles of Liothyronine Sodium Tablets nationwide due to failed quality specifications for impurities and degradation. The affected lots were distributed in 100-count bottles.

    Product
    LIOTHYRONINE SODIUM — LIOTHYRONINE SODIUM (LIOTHYRONINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0507-2024·2023-12-20

    Hungry Root Creamy Vodka Sauce Recalled for Yeast and Mold Contamination

    BC Gourmet USA is recalling Hungry Root Creamy Vodka Sauce (10.5 oz Plastic Cup) due to the presence of yeast and mold. The affected product was distributed in California, New Jersey, and Indiana.

    Product
    Hungry Root Creamy Vodka Sauce; 10.5 oz Plastic Cup; UPC 810062520787
    Category
    Food
    Distribution
    3 states
  • LowFDA (Devices)·Z-0556-2024·2023-12-20

    Medical Device Instructions Update Recall for Navik 3D Mapping System

    APN Health LLC is recalling the Navik 3D v2 3D Mapping System to update the product instructions for use. The firm initiated this voluntary recall.

    Product
    Navik 3D v2, REF NAVIK3D, 3D Mapping System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V862000·2023-12-19

    2022-2023 Tesla Model S and X Door Latch Safety Defect Recall

    Certain 2022-2023 Tesla Model S and X vehicles may have cabin doors that unlock during a crash due to a door latch defect. Tesla is providing a free over-the-air software update to fix the issue.

    Product
    TESLA — TESLA MODEL S, MODEL X
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V861000·2023-12-19

    Van Hool Recalls 2024 CX45 Vehicles Due to Seat Belt Screw Defect

    Van Hool is recalling 64 2024 CX45 vehicles because a seat belt assembly screw may break. This defect could prevent the seat belt from properly restraining occupants during a crash.

    Product
    VAN HOOL — VAN HOOL CX45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V859000·2023-12-19

    Doosan Portable Generator Trailers Recalled for Brake Wiring Defect

    Doosan is recalling 2019-2023 Portable Generator Trailers because the electric brake harness was incorrectly wired, causing brakes to fail when the battery switch is off.

    Product
    DOOSAN PORTABLE POWER — DOOSAN PORTABLE POWER MOBILE GENERATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V860000·2023-12-19

    Airstream Basecamp Travel Trailers Recalled for Failing Spare Tire Bracket

    The spare tire carrier bracket on certain 2012-2023 Airstream Basecamp travel trailers may experience metal fatigue and break, causing the spare tire to detach and become a road hazard. Airstream is providing free replacement and reinforcement of the bracket.

    Product
    AIRSTREAM — AIRSTREAM BASECAMP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V858000·2023-12-18

    Fuel pump failure recall for 2013-2023 Honda and Acura vehicles

    Honda is recalling certain 2013-2023 Honda Accord, Civic, CR-V, HR-V, Odyssey, Pilot, Ridgeline and Acura ILX, MDX, RDX, RLX, TLX vehicles because the fuel pump inside the fuel tank may fail, potentially causing engine stall while driving and increasing crash risk.

    Product
    ACURA — ACURA, HONDA MDX HYBRID, ACCORD HYBRID, CIVIC, PILOT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23E095000·2023-12-18

    Hendrickson Lift Axle Recall Due to Steering Knuckle Assembly Defect

    Hendrickson is recalling certain COMPOSILITE EXS20 and SC20 Lift Axles because bearing journals may not be fully seated, increasing the risk of a crash.

    Product
    STEERING:LINKAGES:KNUCKLE:SPINDLE:ARM recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V857000·2023-12-18

    2024 PJ Trailers Recalled: Defective Tires Cause Pressure Loss

    PJ Trailers is recalling 2024 model trailers due to defective tires that may experience sidewall separation and pressure loss. Dealers will replace affected tires free of charge.

    Product
    PJ TRAILERS — PJ TRAILERS DT, DG, CE, C8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V856000·2023-12-17

    Can-Am Spyder F3 Motorcycle Rearview Mirror Lens Dislodgment Recall

    Bombardier Recreational Products is recalling 2023 Can-Am Spyder F3 and F3-S motorcycles because the rearview mirror lens may dislodge from the housing, reducing driver visibility and increasing crash risk. Dealers will install new mirror assemblies free of charge.

    Product
    CAN-AM — CAN-AM SPYDER F3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V850000·2023-12-15

    Coachmen Concord Motorhomes Recalled for Air Suspension Line Defect

    Forest River is recalling 2023-2024 Coachmen Concord motorhomes because an air suspension line may be installed near the exhaust, risking sudden suspension loss and vehicle control issues.

    Product
    COACHMEN — COACHMEN CONCORD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V854000·2023-12-15

    Mercedes-Benz Recalls Vehicles for Potential Front Roof Panel Detachment

    Mercedes-Benz is recalling 2014-2020 models because the front roof panel may detach, creating a road hazard and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, MERCEDES-MAYBACH redundant S550E, C 350 E, GLA 250, S 560 4MATIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V851000·2023-12-15

    Mercedes-Benz Recalls 2022-2023 AMG G63 Due to Rear Axle Cracks

    Mercedes-Benz is recalling 2022-2023 AMG G63 vehicles because the rear axle differential housing may crack, potentially causing oil leaks or axle failure.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG G63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·063-2023·2023-12-15

    Simmons Recalls TGI Fridays Boneless Chicken Bites Due to Plastic Contamination

    Simmons Prepared Foods is recalling TGI Fridays boneless chicken bites because they may contain pieces of clear, hard plastic. No illnesses have been reported.

    Product
    Simmons Prepared Foods, Inc. — Simmons Prepared Foods, Inc. Recalls Boneless Chicken Bites Products Due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V849000·2023-12-15

    Mercedes-Benz Recalls 2023 Sprinter Vans for Suspension Bolt Issue

    Daimler Vans USA is recalling 2023 Mercedes-Benz Sprinter vans because a front suspension bolt may not be secured properly, which can cause a loss of steering control.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER 4500, SPRINTER 2500, SPRINTER 3500, SPRINTER 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V855000·2023-12-15

    Can-Am Ryker Motorcycles Recalled for Fuel Pump Failure Risk

    Bombardier is recalling 2019-2023 Can-Am Ryker motorcycles because the fuel pump impeller may swell and fail, causing engine stall while driving and increasing crash risk.

    Product
    CAN-AM — CAN-AM RYKER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V848000·2023-12-15

    Ford Maverick Turn Signal Failure Missing Driver Alert Recall

    Ford is recalling 2022-2024 Maverick vehicles because the body control module may fail to alert drivers when a rear turn signal stops working, increasing crash risk.

    Product
    FORD — FORD MAVERICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V847000·2023-12-15

    Certain 2023 Ford F-series trucks recalled for steering column air bag failure

    Ford is recalling approximately 17,970 certain 2023 F-150 and F-250-F-600 trucks because the steering column clock spring may become electrically disconnected, preventing the driver's air bag from deploying in a crash.

    Product
    FORD — FORD F-250 SD, F-450 SD, F-550 SD, F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V853000·2023-12-15

    Mercedes-Benz Recalls 2023 EQE 350 Vehicles for Headlight Software Error

    Mercedes-Benz is recalling 2023 EQE 350 vehicles with comfort suspension because a software error may cause incorrect headlight adjustment, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ EQE350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowNHTSA·23V852000·2023-12-15

    Great Dane Recalls 2023 Champion Trailers for Incorrect VIN Labels

    Great Dane is recalling 2023 Champion trailers because incorrect VINs on certification labels may prevent owners from recognizing safety recalls.

    Product
    GREAT DANE — GREAT DANE CHAMPION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·24056·2023-12-14

    Polaris RZR 200 Youth Off-Road Vehicles Recalled for Steering Lock-Up Hazard

    Polaris is recalling about 19,000 Model Year 2021-2024 RZR 200 youth off-road vehicles because the steering system can lock up during use, posing a crash hazard and risk of serious injury to children.

    Product
    Model Year 2021-2024 RZR 200 Youth ROVs
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·23V845000·2023-12-14

    2019 Chevrolet Bolt EV Fire Hazard After Crash

    General Motors is recalling certain 2017-2023 Chevrolet Bolt EV vehicles where the seat belt pretensioner exhaust may ignite carpet fibers near the B-pillar following a crash, creating a fire risk.

    Product
    CHEVROLET — CHEVROLET BOLT EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24060·2023-12-14

    Room & Board Griffin Duo Bunk Beds Recall Due to Collapse Risk

    Room & Board is recalling about 500 Griffin Duo Bunk Beds sold from May 2013 through May 2017 because some units lack properly installed set screws in the side rail brackets, creating a risk of collapse and fall injuries. Two collapse incidents have been reported with no injuries.

    Product
    Room & Board Griffin Duo Bunk Beds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24736·2023-12-14

    Kubota RTV-XG850 Utility Vehicles Recalled for Steering Hazards

    Kubota is recalling about 3,170 RTV-XG850 Sidekick utility vehicles sold between March 2023 and September 2023 due to improper steering shaft assembly that could cause loss of control and crash hazards.

    Product
    Utility Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24051·2023-12-14

    Empower Brands Recalls PowerXL Dual-Basket Air Fryers Due to Burn Hazard

    Empower Brands is recalling about 319,000 PowerXL DUAF-10 and DUAF-005 Vortex Dual-Basket Air Fryers because the plastic U-Channel connector can break during use, posing a burn hazard. The firm has received 41 reports of breakage, including three burn injuries.

    Product
    PowerXL™ DUAF-10 and DUAF-005 Vortex Dual-Basket Air Fryers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24734·2023-12-14

    Collegiate English Horse-Riding Saddles Recalled for Fall Injury Risk

    WeatherBeeta USA is recalling about 2,300 Collegiate English horse-riding saddles because the rivet or stirrup bar can break, causing the rider to fall. One fall injury has been reported.

    Product
    Collegiate English Horse-Riding Saddles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24735·2023-12-14

    Can-Am Side-by-Side Vehicles Recalled for Clutch Failure Risk

    BRP is recalling about 14,555 Model Year 2022 and 2023 Can-Am Commander, Defender, and Maverick Trail side-by-side vehicles because the operator's guide contains incorrect maintenance intervals for the clutch, which can lead to clutch failure and fragment ejection, posing a risk of serious injury.

    Product
    Can-Am® Commander series, Defender series, Maverick Trail series equipped with an HD7 or 700 engines side-by-side vehicles (Model Year 2022 and 2023)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24055·2023-12-14

    Polaris Ranger XP Kinetic Off-Road Vehicles Recalled Due to Crash Hazard

    Polaris is recalling Model Year 2023-2024 Ranger XP Kinetic recreational off-road vehicles because pressing the brake and throttle pedals together can deactivate the throttle, creating a crash hazard when the brake is released.

    Product
    Model Year 2023-2024 Ranger XP Kinetic Recreational Off-Road Vehicles (ROVs)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V846000·2023-12-14

    Thomas Built Buses Recalls Electric School Buses for Inverter Cable Issue

    Daimler Trucks North America is recalling 2021-2025 Thomas Built SAF-T-LINER C2 Jouley electric school buses because a high voltage inverter cable may not be secured properly, potentially causing a loss of drive power.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2 JOULEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24050·2023-12-14

    Steamfast Travel Steam Irons Recalled for Fire, Burn, and Shock Hazards

    Vornado Air LLC is recalling approximately 1.75 million Steamfast Home & Away Travel Steam Irons because the power cord can become damaged near the bushing, posing fire, burn, and electrical shock hazards.

    Product
    Steamfast Home & Away Travel Steam Irons
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·24058·2023-12-14

    Savvy Rest Quilted Cotton Mattress Pads Recalled for Fire Hazard

    Savvy Rest is recalling about 84 quilted cotton mattress pads because they fail to meet the federal flammability standard for mattress pads and pose a fire hazard. No injuries have been reported.

    Product
    Savvy Rest Quilted Cotton Mattress Pads
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateCPSC·24061·2023-12-14

    Traeger Flatrock Flat Top Propane Grills Recalled for Fire Hazard

    Traeger is recalling about 37,000 Flatrock Flat Top Propane Grills because burner control knobs can be incorrectly labeled, allowing the grill to be unintentionally left on and posing a fire hazard. No fires or injuries have been reported.

    Product
    Traeger Flatrock Flat Top Propane Grills
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0501-2024·2023-12-13

    Turkey Gravy Recalled Due to Undeclared Soy Allergen

    Hy-Vee Turkey Gravy is recalled because it contains undeclared soy. The affected product was distributed to two Hy-Vee distribution centers in Iowa, with 2,000 jars recalled.

    Product
    HyVee Turkey Gravy, Net Wt 12 oz (340g). UPC 0 75450-03608 4. Distributed by Hy-Vee, Inc., West Des Moines, IA 50266
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-0502-2024·2023-12-13

    Hilltop Meadow Farm Raw Milk Cheese Recalled for Listeria Risk

    Hilltop Meadow Farm is recalling Raw Milk Pepper Jack Cheese for potential Listeria monocytogenes contamination. Affected products have sell-by dates through September 2023 and were distributed to retailers in PA, NJ, NY, and WI.

    Product
    Hilltop Meadow Farm Raw Milk Cheese Pepper Jack Aged 60 Days .5 lb., 1 lb., 1.15 lb, 2.5 lb., and 5 lb. UPC: 0 200144 612644. Packaged in clear plastic packaging.
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0616-2024·2023-12-13

    Pico de gallo mix recalled for potential salmonella contamination

    Market Cuts LLC recalls 10-ounce pico de gallo with pineapple clamshells due to potential salmonella contamination. Products with best-by dates November 4–9, 2023, were distributed in Illinois, Indiana, Michigan, and Wisconsin.

    Product
    (No brand) 10 oz Mix Pico de Gallo w/Pineapple 3/8" 10 Ounce clamshell UPC 092538003233; Freshly Made Pico de Gallo w/Pineapple Mix 10 Ounce clamshell UPC 092538003233; Market Cuts 10 oz Mix Pico de Gallo w/Pineapple 3/8" 10 Ounce clamshell UPC 092538003233
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0671-2024·2023-12-13

    Bix Produce Recalls Fruit Medley for Potential Salmonella Contamination

    FreshPoint Bix Produce Company is recalling 91 units of Bix Produce Item #12170 (5 lb. Chunk Melon w/Grape) distributed in Iowa, Minnesota, North Dakota, and Wisconsin due to potential Salmonella contamination.

    Product
    Bix Produce Item # 12170 Fruit, Chunk Melon w/Grape 5 lb. containing Cantaloupe, Honeydew, and Red Grapes. Keep Refrigerated. Manufactured and Distributed by: Bix Produce Company, 3060 Centerville Road, Little Canada, MN 55117
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0667-2024·2023-12-13

    Mixed Fruit Cups Recalled for Potential Salmonella Contamination

    FreshPoint Bix Produce Company is recalling Mixed Fruit Cups due to potential Salmonella contamination. The recall affects 432 units distributed in Iowa, Minnesota, North Dakota, and Wisconsin.

    Product
    Mixed Fruit Cup, clam-shell container. Net Wt 5.75 oz (163g). Keep Refrigerated. Ingredients: Cantaloupe, Honeydew, Pineapple, Red Grapes. Manufactured and Distributed by: Bix Produce Company, 3060 Centerville Road, Little Canada, MN 55117 Packaged with the following…
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0613-2024·2023-12-13

    Food recall: Salmonella contamination in ready-made melon bowls

    Market Cuts LLC is recalling Freshly Made Signature Melon bowls (28oz) due to potential Salmonella contamination affecting products distributed in Illinois, Indiana, Michigan, and Wisconsin.

    Product
    Freshly Made Signature Melon 28oz bowl UPC 092538002274
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0617-2024·2023-12-13

    Whole Cantaloupe Recalled for Potential Salmonella Contamination

    TruFresh in Nogales, AZ has issued a voluntary recall of whole cantaloupe sourced from Malichita, Mexico, due to potential Salmonella contamination.

    Product
    Whole cantaloupe 3ct and 6ct
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-0665-2024·2023-12-13

    FreshPoint Bix Produce Company Cantaloupe Recall Due to Salmonella Risk

    FreshPoint Bix Produce Company is recalling whole cantaloupes due to potential Salmonella contamination. The recall affects approximately 186 packs distributed across Iowa, Minnesota, North Dakota, and Wisconsin.

    Product
    FreshPoint Bix Produce Company, Whole Cantaloupe, Item 03143. 1/3 CT. 3 melons per container.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0612-2024·2023-12-13

    Freshly Made Signature Fruit Bowl Recalled for Salmonella

    Market Cuts LLC is recalling Freshly Made Signature Fruit 32oz bowls due to potential Salmonella contamination. Products affected have Best By dates 11/4/2023 to 11/9/2023 and were distributed in IL, IN, MI, and WI.

    Product
    Freshly Made Signature Fruit 32oz bowl UPC 092538002298
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0669-2024·2023-12-13

    Mixed Fruit with Grapes Recalled for Potential Salmonella Contamination

    FreshPoint Bix Produce Company is recalling Mixed Fruit with Grapes products due to potential Salmonella contamination. Affected products were distributed in Iowa, Minnesota, North Dakota, and Wisconsin.

    Product
    Bix Produce Mixed Fruit with Grapes products containing Cantaloupe, Honeydew, Pineapple, and Red Grapes. Keep Refrigerated. Manufactured and Distributed by: Bix Produce Company, 3060 Centerville Road, Little Canada, MN 55117 Packaged with the following cuts and weights…
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0609-2024·2023-12-13

    Cantaloupe Chunks Recalled for Salmonella Risk, Class I

    Market Cuts LLC initiated a recall of cantaloupe chunks sold under the Little Salad Bar and Market Cuts brands due to potential Salmonella contamination. Affected products were distributed in Illinois, Indiana, Michigan, and Wisconsin.

    Product
    Little Salad Bar Cantaloupe Chunks, 1lb clamshell UPC 4099100215885; Market Cuts Cantaloupe Chunk 1" 1/5lb Tray, 5lb tray; Market Cuts1 lb Cantaloupe Chunk 1"x1", 1lb clamshell UPC 092538001277; Market Cuts Cantaloupe Chunk 1" 2/5lb Tray, 5lb tray; Market Cuts Cantaloupe Chunk…
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0569-2024·2023-12-13

    Rudy brand whole cantaloupes recalled due to possible Salmonella contamination

    Sofia Produce, L.L.C. is recalling Rudy brand whole cantaloupes distributed across the United States and Canada due to possible Salmonella contamination.

    Product
    Whole cantaloupe, Brand name Rudy 11 count carton, 8 count carton, 9 count carton, 15 count carton d. Container description; Cardboard containers bearing the Rudy label. The Rudy brand cantaloupes also have an individual PLU sticker placed upon each cantaloupe, PLU sticker #…
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Food)·F-0611-2024·2023-12-13

    Food Recall: Market Cuts Fruit Mix Products Due to Salmonella

    Market Cuts LLC is recalling fruit mix products distributed in Illinois, Indiana, Michigan, and Wisconsin due to salmonella. The voluntary recall, initiated November 9, 2023, affects 434 units with best-by dates from November 4–9, 2023.

    Product
    Market Cuts Fruit Mix Standard 1/5lb Tray 5 Pound tray; Market Cuts 1 lb Fruit Mix Chunk 1" 1 Pound clamshell UPC 092538000461; Market Cuts Fruit Mix Standard 2/5lb Tray 5 Pound tray; Market Cuts 20 oz Bowl Fruit Small 20 Ounce bowl UPC 092538000577; Freshly Made Mixed Fruit 10…
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0144-2024·2023-12-13

    FDA Recalls SANDIMMUNE Oral Solution Due to Crystallization

    Novartis Pharmaceuticals is recalling SANDIMMUNE Oral Solution (cyclosporine 100 mg/mL) due to crystallization found in bottles. The affected lots were distributed nationwide.

    Product
    SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM Huningue S.A.S., Huningue, France, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936. NDC 0078-0110-22
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0672-2024·2023-12-13

    Bix Produce Mixed Fruit Recall for Potential Salmonella Contamination

    FreshPoint Bix Produce Company is recalling Item #12217 mixed fruit (cantaloupe, pineapple, red grapes) due to potential Salmonella contamination. The product was distributed in Iowa, Minnesota, North Dakota, and Wisconsin.

    Product
    Bix Produce Item # 12217 Fruit, Chk Cant/Pine 1/2" w/Grp, 5 lb. containing Cantaloupe, Pineapple, and Red Grapes. Keep Refrigerated. Manufactured and Distributed by: Bix Produce Company, 3060 Centerville Road, Little Canada, MN 55117
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0666-2024·2023-12-13

    FreshPoint Bix Produce Cantaloupe Fruit Cup Recalled for Potential Salmonella

    FreshPoint Bix Produce Company is recalling specific lots of Cantaloupe Fruit Cup (Item 19703) due to potential Salmonella contamination. Affected products were distributed to Iowa, Minnesota, North Dakota, and Wisconsin.

    Product
    Cantaloupe Fruit Cup, Item 19703. clam-shell container. Net Wt 5.75 oz (163g). UPC 8 46709-00523 2. Manufactured and Distributed by: Bix Produce Company, 3060 Centerville Road, Little Canada, MN 55117
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0615-2024·2023-12-13

    Market Cuts Fruit Trays with Cream Cheese Recalled for Salmonella

    Market Cuts LLC voluntarily recalled 40 oz and 80 oz Combo Tray Fruit products with cream cheese due to potential Salmonella contamination. The recall affected products distributed in Illinois, Indiana, Michigan, and Wisconsin.

    Product
    Market Cuts 40 oz Combo Tray Fruit Small w/ Cream Cheese 40 Ounce tray UPC 092538002755; Market Cuts 80 oz Combo Tray Fruit Large w/ Cream Cheese 80 Ounce tray UPC 092538002748
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0670-2024·2023-12-13

    Mixed Fruit Products Recalled for Potential Salmonella Contamination

    Bix Produce Mixed Fruit products containing cantaloupe, honeydew, and pineapple are recalled due to potential Salmonella contamination. Consumers should not consume the affected products.

    Product
    Bix Produce Mixed Fruit products containing Cantaloupe, Honeydew, and Pineapple. Keep Refrigerated. Manufactured and Distributed by: Bix Produce Company, 3060 Centerville Road, Little Canada, MN 55117 Packaged with the following cuts and weights: 1. Item # 12192…
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0668-2024·2023-12-13

    Bix Produce Cut Cantaloupe Recalled for Potential Salmonella Contamination

    FreshPoint Bix Produce Company is recalling 1,355 units of cut cantaloupe products due to potential Salmonella contamination. Products were distributed in Iowa, Minnesota, North Dakota, and Wisconsin.

    Product
    Bix Produce Cut Cantaloupe. Keep Refrigerated. Manufactured and Distributed by: Bix Produce Company, 3060 Centerville Road, Little Canada, MN 55117 Packaged with the following cuts and weights: 1. Item # 12064, Fruit, Balls small Cantaloupe, 5 lb. 2. Item # 12070…
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0610-2024·2023-12-13

    Pineapple Products from Market Cuts Recalled for Possible Salmonella Contamination

    Market Cuts is recalling multiple pineapple products due to potential Salmonella contamination. The recall affects products distributed in Illinois, Indiana, Michigan, and Wisconsin.

    Product
    Market Cuts 1 lb Pineapple Spear 1 Pound clamshell UPC 092538001239; Market Cuts 1 lb Pineapple Chunk 1"x1" 1 Pound clamshell UPC 092538001284; Market Cuts Pineapple Chunk 1" 2/5lb Tray 5 Pound tray; Market Cuts Pineapple Chunk 1" 1/5lb Tray 5 Pound tray; Market Cuts 6 oz…
    Category
    Food
    Distribution
    4 states
  • SevereNHTSA·23V843000·2023-12-13

    Thomas Built Buses Recalls School Buses for Weak Rear Joint

    Daimler Trucks North America is recalling 321 Thomas Built school buses because a rear interior joint may be too weak, increasing injury risk in a crash.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER C2, SAF-T-LINER C2 JOULEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0614-2024·2023-12-13

    Fruit Combo Trays Recalled for Possible Salmonella Contamination

    Market Cuts fruit combo trays (40 oz and 80 oz) are recalled due to possible salmonella contamination. Affected products were distributed in Illinois, Indiana, Michigan, and Wisconsin between November 4–9, 2023.

    Product
    Market Cuts 40 oz Combo Tray Fruit Small 40 Ounce tray UPC 092538001611; (No brand) 80 oz Combo Tray Fruit Large 80 Ounce tray UPC 092538001604; (No brand) 40 oz Combo Tray Fruit Small 40 Ounce tray UPC 092538001611; Market Cuts 80 oz Combo Tray Fruit Large 80 Ounce tray UPC…
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0355-2024·2023-12-13

    Infusomat Administration Sets recalled for tubing dimension defects

    B. Braun Infusomat Administration Sets may have incorrect tubing dimensions that cause false air-in-line alarms, interrupting medication delivery. The defects may prevent critical medications from reaching patients.

    Product
    Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 drops/mL, priming volume: 22mL, length: 119in, SafeLine; 362033 UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE; 362034 Priming volume: 19mL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0420-2024·2023-12-13

    CARDIOHELP Emergency Drive Blockage May Impair Cardiac Blood Oxygenation

    The FDA is recalling CARDIOHELP Emergency Drive units due to potential blocking that impairs blood flow. Affected patients may experience ischemia and hypoxia from inappropriate low blood oxygen.

    Product
    CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0138-2024·2023-12-13

    Dietary supplement recalled for unapproved drug status and pharmaceutical contamination

    Dr. Ergin's SugarMD glucose support capsules are recalled nationwide because they were marketed without FDA approval and are contaminated with the pharmaceutical ingredients metformin and glyburide. Approximately 32,117 units were distributed in the U.S.

    Product
    Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 count (UPC 1 95893 92767 8), b) 120 count (UPC 1 95893 54697 8), c) 180 count (UPC 1 95893 99957 6) bottles, Manufactured for SUGARMDS LLC, Port St. Lucie, FL…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0601-2024·2023-12-13

    Imperial Fresh whole cantaloupes recalled due to possible Salmonella contamination

    Freshpoint Of Southern Ca is recalling Imperial Fresh whole cantaloupes (3ct and 6ct) distributed to food services in California, Arizona, and Nevada due to possible Salmonella contamination.

    Product
    Whole cantaloupe 3ct and 6ct brand name Imperial Fresh
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0568-2024·2023-12-13

    Malichita whole cantaloupe recalled for possible Salmonella contamination

    Sofia Produce recalls Malichita brand whole cantaloupes for possible Salmonella contamination. The recall affects approximately 18,335 boxes distributed to multiple U.S. states and Canada.

    Product
    Whole cantaloupe, Brand name Malichita 11 count carton, 8 count carton, 9 count carton, 15 count carton d. Container description; Red Corrugated Paper Carton or Black Plastic RPC.
    Category
    Food
    Distribution
    20 states
  • HighFDA (Devices)·Z-0438-2024·2023-12-13

    CardioQuip Modular Cooler-Heater heating chamber malfunction poses burn risk

    CardioQuip is recalling 150 units of its Modular Cooler-Heater (Model MCH-1000m) due to potential heating-chamber malfunction that could cause component melting or burning. The device may overheat unexpectedly.

    Product
    CardioQuip Modular Cooler-Heater, Model:MCH-1000(m), Power: 115V-60hz,16A
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-0446-2024·2023-12-13

    Medical radiation therapy system detector arm extension recall

    Elekta recalls Infinity radiation therapy systems for a detector arm defect that could cause uncontrolled extension if a microswitch is improperly configured. No injuries reported.

    Product
    ELEKTA LIMITED Elekta Infinity, REF XRT 0511, XRT 0521, XRT 0531, XRT 0541; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0461-2024·2023-12-13

    Quantum TTC Biliary Balloon Dilator Recalled for Balloon Detachment Risk

    Wilson-Cook Medical is recalling QUANTUM TTC BILIARY BALLOON DILATORS due to nonconforming devices that may detach during use. Detachment could require endoscopic retrieval and carries a risk of bleeding.

    Product
    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0474-2024·2023-12-13

    EVO VISIAN Intraocular Lenses recalled for potential specification defects

    Staar Surgical Company is recalling 9 EVO VISIAN intraocular lenses due to potential specification non-compliance. The affected devices were distributed to 40 US states.

    Product
    EVO VISIAN Implantable Collamer Lens, REF: VICMO12.6. Phakic Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Food)·F-0488-2024·2023-12-13

    BAPS Shayona Ricotta Fudge Discs Recalled for Undeclared Soy

    BAPS Shayona is recalling 723 units of Plain Penda Ricotta fudge discs because some contain undeclared soy. The product was distributed to six states and poses a risk for those with soy allergies.

    Product
    BAPS SHAYONA Plain Penda Ricotta fudge discs flavored with rose water Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53152 Contains: Milk, Nut
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0477-2024·2023-12-13

    HVAD Ventricular Assist Device Updated Instructions for Alarm Conditions

    Heartware is providing updated instructions for the HVAD ventricular assist device to clarify Controller Fault alarm conditions and device useful life information for 892 implanted units worldwide.

    Product
    HVAD (HeartWare Ventricular Assist Device) STERILE IMPLANT KIT, Model Number 1102
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0489-2024·2023-12-13

    BAPS Shayona Kaju Katri Cashew Fudge Recalled for Undeclared Yellow #5 Dye

    BAPS Shayona Kaju Katri Kesar (cashew fudge with saffron) is being recalled because it contains undeclared Yellow #5 dye. The product was distributed to Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.

    Product
    BAPS SHAYONA Kaju Katri Kesar Cashew fudge flavored with saffron Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53065 Contains: Nut
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0457-2024·2023-12-13

    Biliary balloon dilators recalled due to design nonconformity and detachment risk

    Wilson-Cook Medical recalled 731 QUANTUM TTC biliary balloon dilators due to design nonconformity that could cause balloon detachment. The device failure may require endoscopic retrieval and risks bleeding complications.

    Product
    QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0466-2024·2023-12-13

    EVO+VISIAN Implantable Collamer Lens Recalled for Specification Non-Compliance

    Staar Surgical recalls 51 EVO+VISIAN intraocular lenses due to potential specification non-compliance. Affected devices were distributed across multiple U.S. states.

    Product
    EVO+VISIAN Implantable Collamer Lens, REF: VICM5_13.2. Phakic Intraocular lens.
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Drugs)·D-0147-2024·2023-12-13

    ROPivacaine HCl Injection Bags Recalled Due to Leaking

    STAQ Pharma is recalling ROPivacaine HCl 0.2% injection bags nationwide due to leaking bags caused by manufacturing quality control failures. No illnesses or injuries have been reported.

    Product
    ROPivacaine HCl 0.2% PF in Sodium Chloride 1,000 mg/500 mL (2 mg per mL) Injection, 500 mL bags, Rx only, STAQ Pharma Inc. 14135 E 42nd Ave, Unit 50, Denver, Colorado 80239, NDC 73177-0109-26,
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0501-2024·2023-12-13

    RANDOX Total Bilirubin Reagent Recall Due to Elevated Patient Results

    Randox is recalling RANDOX Total Bilirubin reagent because reports indicate elevated patient results when using plasma samples with this reagent.

    Product
    RANDOX Total Bilirubin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0426-2024·2023-12-13

    ProCuity Hospital Beds Missing Electrical Safety Test Data

    Stryker's ProCuity bed series model 3009 lacks required electrical safety test documentation, creating a risk of tissue burns or electrical shock. The beds are distributed across North America, Europe, and other regions.

    Product
    ProCuity bed series, model number 3009, item number: 3009PX-L-200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0495-2024·2023-12-13

    Integra Cranial Access Kit Recalled for Packaging Defect Compromising Sterility

    Integra LifeSciences is recalling 510 units of Cranial Access Kits due to a defect in outer packaging that can split spontaneously, compromising device sterility and increasing infection risk in neurosurgery.

    Product
    Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7260
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0452-2024·2023-12-13

    Ceiling-mounted equipment dispensers recalled for weakened suspension arm

    IHB Operations is recalling Freedom Boom ceiling-mounted equipment dispensers due to weakened connection points on the suspension arm that could cause equipment failure. The defect affects 1,497 units distributed across multiple US states.

    Product
    Freedom Boom models series: F110, F120, F130, F320, F330, F350, F410, and F420 with built in 42A Lightweight Spring Arm part numbers 42A-43L, 42A-43M, 42A-43H, and 42A-43S. Ceiling mounted utilities and equipment dispensing system.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-0504-2024·2023-12-13

    Medical Catheter Sets Recalled Due to Bonding Material Defect

    CooperSurgical H/S Catheter Sets may have defective bonding material causing component detachment or leakage. The sets are used in hysterosalpingography procedures to detect uterine abnormalities.

    Product
    CooperSurgical H/S CATHETER SET FR 5 with Integated Stylet Model: 61-4005S For administering contrast media during Hysterosalpingography or Hysterosonography procedures to detect uterine pathology such as polyps, fibroids, adhesions or endometrial thickening, and/or patency…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0494-2024·2023-12-13

    Integra Cranial Access Kit Packaging Defect Compromises Sterility

    Integra LifeSciences is recalling 180 Cranial Access Kits due to a packaging defect that can cause splits, compromising the sterility of the surgical device.

    Product
    Integra¿ Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7280
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0478-2024·2023-12-13

    Medical Device Instruction Update: HVAD Ventricular Assist Device Clarifications

    HeartWare is issuing clarifications to instructions for the PUMP 1103 HVAD ventricular assist device regarding when Controller Fault alarms sound and component useful life. No illnesses or injuries have been reported.

    Product
    PUMP 1103 HVAD (HeartWare Ventricular Assist Device) IMPLANT KIT, Model Number 1103
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0499-2024·2023-12-13

    Milled Golden Flax Recalled for Plastic Foreign Object Contamination

    Scoular Grain Co is recalling Milled Golden Flax MGDF in 50 lb bags due to plastic foreign object contamination. Affected lot numbers REG23261 and REG23268 were distributed to Texas and Canada.

    Product
    Milled Golden Flax MGDF, 50 lb bag
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0499-2024·2023-12-13

    Cranial Access Kit Packaging Defect May Compromise Sterility

    Integra LifeSciences is recalling a cranial access kit due to a packaging defect that can cause the sterile outer packaging to split without additional force, potentially compromising device sterility.

    Product
    Combo Kit Consists OF 10-110/INS-4500/INS-7040- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: 31004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0496-2024·2023-12-13

    Cranial Access Kit Recall Due to Packaging Defect Compromising Sterility

    Integra LifeSciences is recalling 485 Cranial Access Kits (Catalog INS7250) due to a packaging defect that can cause spontaneous splitting, compromising device sterility. The kits are used for surgical access to the brain.

    Product
    Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS7250
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0491-2024·2023-12-13

    Integra Cranial Access Kit Recalled for Defective Outer Packaging

    Integra LifeSciences is recalling 1,639 units of its Cranial Access Kits because the outer packaging may split without additional external force, potentially compromising device sterility.

    Product
    Integra Cranial access kit (without Prep solutions) Bit and Guard-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: INS5HND
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0455-2024·2023-12-13

    NovoTHOR Gen 2.5 Therapy Bed Recalled for Ball Stud Failure

    Thor Photomedicine's NovoTHOR Gen 2.5 therapy beds are being recalled due to failure of ball stud components in the gas strut, which can detach from the canopy. This affects 26 units distributed across the US and internationally.

    Product
    NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0495-2024·2023-12-13

    BAPS SHAYONA Surti Ghari sweet dumplings recalled for undeclared soy and Yellow #6

    BAPS SHAYONA Surti Ghari sweet dumplings are recalled due to undeclared soy and Yellow #6 dye. The product was distributed in Alabama, Florida, Georgia, North Carolina, South Carolina, and Tennessee.

    Product
    BAPS SHAYONA Surti Ghari Sweet dumplings stuffed with minced nuts and glazed with clarified butter Net Wt: 12 Oz 460 Rockbridge Rd NW Lilburn, GA 30047 UPC 53102 Contains: Milk
    Category
    Food
    Distribution
    6 states
  • HighFDA (Devices)·Z-0476-2024·2023-12-13

    HeartWare HVAD Ventricular Assist Device Documentation Update

    HeartWare is updating documentation for 380 HVAD cardiac assist devices to clarify Controller Fault alarm conditions and device lifetime instructions.

    Product
    STERILE HVAD (HeartWare Ventricular Assist Device) PUMP (US), Model Number 1101
    Category
    Medical Device
    Distribution
    0 states

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