The Recall Desk

Archive

December 2024 recalls

558 recalls were announced in December 2024.

What the numbers show

Critical
6
Severe
72
High
409
Moderate
70
Low
1

Of the 558 recalls this month scored against our rubric, 1% are Critical, 13% are Severe.

201–300 of 558

  • HighNHTSA·24E106000·2024-12-17

    Cummins Recalls Diesel Engines Due to Coolant Leak Risk

    Cummins is recalling specific B6.7 and F3.8 diesel engines because an incorrect rubber elbow in the cooling system can leak hot coolant, posing an injury risk to bystanders.

    Product
    ENGINE AND ENGINE COOLING:COOLING SYSTEM:HOSES/LINES/PIPING/FITTINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V933000·2024-12-17

    2024 VinFast VF8 vehicles recalled for center air bag deployment risk

    VinFast is recalling 2023–2025 VF8 vehicles because the center air bag in the driver's seat may deploy improperly during a side impact crash and strike the driver's arm, increasing injury risk.

    Product
    VINFAST — VINFAST VF 8
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V932000·2024-12-16

    Mitsubishi Fuso Recalls 2024 Rizon Trucks Due to Drive Power Loss Risk

    Mitsubishi Fuso is recalling 2024 Rizon FEC7K and FEC9K trucks because a control unit malfunction may cause loss of drive power, increasing crash risk.

    Product
    MITSUBISHI FUSO — MITSUBISHI FUSO RIZON FEC9K (E18), RIZON FEC7K (E16)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V931000·2024-12-13

    Featherlite Recalls 2023-2024 Horse Trailers Due to Fire Risk

    Featherlite is recalling 2023-2024 Living Quarters Horse Trailers because a rubber gas line may overheat and cause a fire. Dealers will install a copper extension free of charge.

    Product
    FEATHERLITE — FEATHERLITE 9807, 7841, 9808, 7821
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V930000·2024-12-13

    2019-2022 Mercedes-Benz Sprinter instrument cluster may be too bright

    Daimler Vans USA is recalling 2019-2022 Mercedes-Benz Sprinter vehicles. The instrument cluster illumination may be too bright and non-adjustable, making it difficult for drivers to see critical safety information and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER 2500, SPRINTER 1500, SPRINTER 4500, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·25063·2024-12-12

    Stanley Recalls 2.6 Million Travel Mugs for Burn Hazard

    Stanley is recalling 2.6 million Switchback and Trigger Action travel mugs whose lids can detach during use, causing burn injuries. The company has received 91 reports worldwide (16 in the U.S.) of lid detachment resulting in 38 burn injuries, with 11 requiring medical attention.

    Product
    Switchback and Trigger Action travel mugs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·25066·2024-12-12

    HTRC C240 Battery Chargers Recalled for Fire and Burn Hazards

    HTRC C240 battery chargers may ignite or cause connected batteries to ignite, posing fire and burn hazards. The recall affects about 34,600 units sold online from December 2017 through June 2024.

    Product
    HTRC C240 battery chargers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V926000·2024-12-12

    2024 Jeep Grand Cherokee Radiator Crossmember Bolts May Not Be Properly Secured

    Chrysler is recalling 631 units of the 2024 Jeep Grand Cherokee and Grand Cherokee L due to unsecured radiator crossmember bolts that may cause improper airbag deployment and fuel leaks during crashes, increasing injury and fire risks.

    Product
    JEEP — JEEP GRAND CHEROKEE L, GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V925000·2024-12-12

    2025 Chevrolet Equinox EV Pedestrian Alert Sound System Defect

    General Motors is recalling 7,606 2025 Chevrolet Equinox EV vehicles due to incorrect pedestrian alert sound software that fails to produce sufficient volume. This violates federal safety standards and may increase the risk of pedestrian injury.

    Product
    CHEVROLET — CHEVROLET EQUINOX EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·25067·2024-12-12

    Wireless Tree Light Controllers Recalled Due to Fire Hazard

    Wireless tree light controllers sold at Walmart, Target, and Cracker Barrel are being recalled because the receiver can overheat and catch fire. Ten overheating incidents and one fire have been reported, with no injuries.

    Product
    Wireless Decorative Tree Light Controllers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25065·2024-12-12

    Yoto Mini speakers recalled for battery fire and burn hazards

    Yoto Inc. is recalling approximately 251,165 Yoto Mini speakers because the lithium-ion battery can overheat and catch fire. No injuries have been reported, but consumers should stop using the product and contact Yoto for a free battery replacement kit.

    Product
    Yoto Mini speakers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·25064·2024-12-12

    Wall Teester Bed Crowns Recalled Due to Mounting Tab Failure

    Touch of Class is recalling about 890 Wall Teester Bed Crowns because their welded mounting tabs can weaken and fail, causing the crown to fall from the wall. One injury has been reported.

    Product
    Wall Teester Bed Crowns
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0248-2025·2024-12-11

    Albertsons Ready-Meal Salads Recalled for Listeria Contamination

    Albertsons Companies LLC recalls multiple ready-meal salad products due to Listeria monocytogenes contamination in cooked chicken. Products were distributed across 21 US states with sell-through dates through October 13, 2024.

    Product
    (1) GINGER CHICKEN BROCCOLI SALAD FS (UPC 27110800000) (2) READY MEALS GINGER CHICKEN BROCOLLI SALAD SS (UPC 29105700000) (3) GINGER BROCOLLI SALAD FS (UPC 29233600000) (4) CHICKEN CAESAR SALAD FS (UPC 29130700000) (5) CAESAR CHICKEN BOWL (UPC 29125500000) (6) READY MEALS…
    Category
    Food
    Distribution
    21 states
  • SevereNHTSA·24E104000·2024-12-11

    ATP Recalls Air Brake Tubing Due to Bursting Risk

    Advanced Technology Products is recalling specific air brake tubing that may crack and burst under pressure, potentially causing a loss of braking ability.

    Product
    SERVICE BRAKES, AIR:SUPPLY:HOSES, LINES/PIPING, AND FITTINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0084-2025·2024-12-11

    PeakMax Capsules Recalled for Undeclared Sildenafil and Diclofenac

    PeakMax Capsules contain undeclared sildenafil and diclofenac and were marketed without FDA approval. This Class I recall affects capsules distributed nationwide.

    Product
    PeakMax Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: PeakMax, San Francisco, CA, www.PeakMax.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0257-2025·2024-12-11

    Fresh Express Salad Bowls Recalled for Potential Listeria Contamination

    Fresh Express Gourmet Cafe Santa Fe Greek salad bowls are being recalled due to potential Listeria monocytogenes contamination linked to a chicken ingredient recall. No illnesses have been reported.

    Product
    Fresh Express Gourmet Cafe Santa Fe Greek 5.2 oz, Labeled Salad Bowls, Refrigerate, UPC Code: 71279 40713 5 and Case Code :71279-56704
    Category
    Food
    Distribution
    12 states
  • SevereNHTSA·24V924000·2024-12-11

    Freightliner M2 Emergency Vehicles Recalled for Engine Shutdown Risk

    Daimler Trucks is recalling 2015-2020 Freightliner Business Class M2 emergency vehicles because software may cause unexpected engine shutdowns, delaying responders.

    Product
    FREIGHTLINER — FREIGHTLINER BUSINESS CLASS M2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0256-2025·2024-12-11

    Fresh Express Chicken Caesar Salad Bowls Recalled for Listeria Monocytogenes

    Fresh Express Gourmet Cafe Chicken Caesar salad bowls are being recalled due to potential Listeria monocytogenes contamination linked to a Bruce Pac recall. The recall affects products distributed across multiple U.S. states.

    Product
    Fresh Express Gourmet Cafe Chicken Caesar 5.75oz, Labeled Salad Bowls, Refrigerate, UPC Code: 71279407074 and Case Code:071279565620
    Category
    Food
    Distribution
    12 states
  • SevereFDA (Drugs)·D-0083-2025·2024-12-11

    VitalityXtra Capsules Recalled for Undeclared Sildenafil and Diclofenac

    VitalityXtra Capsules containing undeclared sildenafil and diclofenac are being recalled nationwide. The product was marketed without required FDA approval and poses health risks from undeclared pharmaceutical ingredients.

    Product
    VitalityXtra Capsules, 500 mg, packaged in 10 count blisters in cartons, Distributed by: VitalityXtra, San Francisco, CA www.vitalityxtra.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0085-2025·2024-12-11

    ZoomMax Capsules contain undeclared sildenafil and diclofenac

    ZoomMax Capsules have been recalled by the FDA due to containing undeclared sildenafil and diclofenac. The product was marketed without FDA approval.

    Product
    ZoomMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZoomMax, 2108 N St. Sacramento, CA 95816, www.zoommax.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0086-2025·2024-12-11

    ZapMax Capsules Recalled for Undeclared Sildenafil and Diclofenac

    ZapMax Capsules, 500 mg are recalled for containing undeclared sildenafil and diclofenac without FDA approval. The product was distributed nationwide; consumers should stop using immediately and consult their healthcare provider.

    Product
    ZapMax Capsules, 500 mg, 10 count blisters in cartons, Distributed by: ZapMax, 2108 N St. Sacramento, CA 95816, www.zapmax.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0255-2025·2024-12-11

    Enoki Mushrooms Recalled for Potential Listeria Contamination

    HH Fresh Trading is recalling enoki mushrooms distributed to West Virginia retail stores due to potential Listeria monocytogenes contamination. Consumers should not consume this product.

    Product
    ENOKI MUSHROOM; 200g/package (25 packages/case); vacuum packed; refrigerated "***ENOKI MUSHROOM***Net WT***200g(1.05oz)***To keep sealed & cold Product of Taiwan Distributed by: HH Fresh Trading Los Angeles CA 90063 Exported by JIA YANG INTERNATIONAL ENTERPRISES CO., LTD.…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0245-2025·2024-12-11

    Wegmans Asian Sesame Salad recalled for undeclared egg

    Wegmans Large Asian Sesame Salad with Chicken contains undeclared egg, a common allergen. The recall affects 365 units distributed across nine states.

    Product
    Wegmans Large Asian Sesame Salad with Chicken and Asian Peanut Dressing.
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-0643-2025·2024-12-11

    MEDLINE Surgical Convenience Kits Recalled for Defective Smoke Evacuation Component

    MEDLINE is recalling surgical convenience kits nationwide because they contain smoke evacuation pencil components from a Stryker product that was previously recalled. The affected kits are used in robotic and laparoscopic surgical procedures.

    Product
    MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF CDS980998L; 4) ROBOTIC PROCEDURE, REF CDS982128P; 5) ROBOTIC, REF CDS984262N; 6) GYN LAPAROSCOPY, REF CDS984900M; 7) GYN…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0240-2025·2024-12-11

    THIRSTER Lemonade Drink Mix Recalled for Metal Fragment Contamination

    DYMA Brands recalls THIRSTER Lemonade Drink Mix because a damaged sifter used in dextrose production introduced metal fragments into the product. The product was distributed to 29 states.

    Product
    THIRSTER Lemonade Drink Mix NATURALLY FLAVORED LOW CALORIE, NET WT. 8.6 OZ (244 g), UPC 7 58108 39736 4, Case UPC 50758108397359, DISTRIBUTED BY US FOODS, INC. ROSEMONT, IL 60018
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·F-0226-2025·2024-12-11

    Gordon CHOICE Lemonade Mix Recalled for Metal Fragment Contamination

    Gordon CHOICE Lemonade Beverage Mix is being recalled for metal fragment contamination in the product. Consumers should stop using affected packages and contact the manufacturer.

    Product
    Gordon CHOICE Lemonade Beverage Mix Naturally Flavored Low Calorie Instant LOW CAL LEMONADE, NET WT. 8.6 OZ (243 g), UPC 0 93901 59605 5, Case UPC 10093901596052, FOR DISTRIBUTION EXCLUSIVELY BY PARA SU DISTRIBUCION EXCLUSIVA POR GORDON FOOD SERVICE WYOMING, MI 49509
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·F-0233-2025·2024-12-11

    Sysco Pink Lemonade Drink Mix Recalled for Metal Fragment Contamination

    Sysco Classic Pink Lemonade Drink Mix is recalled because a damaged sifter during production introduced metal fragments into the product. Products were distributed across 29 states.

    Product
    Sysco Classic Pink Lemonade Drink Mix Natural Flavor, NET WT. 24OZ(1 LB 8 OZ) 680 g, UPC 0 74865 09326 2, Case UPC 10074865093269, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·F-0231-2025·2024-12-11

    Sysco Fruit Punch Drink Mix recalled for metal fragments

    Sysco Classic Fruit Punch Drink Mix is being recalled due to metal fragments introduced by a damaged sifter during manufacturing. The affected product (Case UPC 00734730132709, Lot 263 EFA) was distributed across 29 states.

    Product
    Sysco Classic Fruit Punch Drink Mix Natural and Artificial Flavor, NET WT. 8.6OZ (244 G), Case UPC 00734730132709, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
    Category
    Food
    Distribution
    30 states
  • HighFDA (Drugs)·D-0094-2025·2024-12-11

    Diltiazem Hydrochloride Capsules Recalled Due to N-Nitroso Impurity Above Limits

    Glenmark Pharmaceuticals recalls Diltiazem Hydrochloride extended-release capsules due to presence of N-nitroso-desmethyl-diltiazem impurity above FDA recommended limits. The recall affects 12,864 bottles distributed nationwide.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0227-2025·2024-12-11

    Katy's KITCHEN Gelatin Mix Recalled for Metal Fragments

    Katy's KITCHEN Originals gelatin mix products are being recalled because a damaged sifter introduced metal fragments during manufacturing. The affected flavors are Lemon, Lime, and Orange, distributed across 29 states.

    Product
    Katy's KITCHEN Originals LEMON GELATIN MIX MEXCLA DE GELATINA DE LIMON, NET WT. 24 OZ. (1.5 LBS.) 680 g, UPC 8 22486 11794 8, Case UPC 30822486117918; Katy's KITCHEN Originals LIME GELATIN MIX, NET WT. 24 OZ. (1.5 LBS.) 680 g, UPC 8 22486 11795 5 & Katy's KITCHEN Originals…
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·F-0246-2025·2024-12-11

    Albertsons Green Chili Chicken Enchiladas Recalled for Listeria Contamination

    Albertsons is recalling two green chicken enchilada meal kit products due to Listeria monocytogenes contamination in the cooked chicken. Affected products were distributed across 20 states with sell-through dates up to October 13, 2024.

    Product
    (1) READY MEALS GREEN CHILI CHICKEN ENCHILADAS SS COLD (UPC 21291600000) (2) GREEN CHICKEN ENCHILADAS 6 CT SS COLD (UPC 27163500000)
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-0253-2025·2024-12-11

    Traditional Country Canning spaghetti sauce recalled for undeclared egg allergen

    Englewood Cannery is recalling Traditional Country Canning Spaghetti Sauce (16 oz.) because it contains undeclared egg, a common allergen. The affected product was distributed in Alabama and Tennessee.

    Product
    Traditional Country Canning Spaghetti Sauce, Net Wt. 16 oz. (453g), packaged in glass jars with metal lids, 12 jars per case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Drugs)·D-0077-2025·2024-12-11

    FDA Recalls Cinacalcet 30mg Tablets for N-nitroso Impurity

    Aurobindo Pharma USA is recalling Cinacalcet 30mg tablets nationwide due to N-nitroso Cinacalcet impurity above FDA limits. Patients should contact their healthcare provider about their medication.

    Product
    Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0638-2025·2024-12-11

    MEDLINE medical convenience kits recalled for defective component

    Medline is recalling medical convenience kits (CLEAN CLOSING PACK and CLEAN CLOSURE PACK GREEN) distributed nationwide because they contain a SafeAir Smoke Evacuation Pencil component that was recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A; 2) CLEAN CLOSURE PACK GREEN, REF DYNJ84667
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0222-2025·2024-12-11

    AROMA VITA Hot Cocoa Mix Recalled for Metal Fragments

    AROMA VITA Hot Cocoa Mix is being recalled due to metal fragments in the product caused by a damaged sifter used during dextrose production.

    Product
    AROMA VITA HOT COCOA MIX, NET WT. 32OZ (2LBS) 907g, UPC 7 1908 50007 0, Case UPC 50719098500075, Distributed by DYMA Brands, Inc. Atlanta, GA 30328
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0608-2025·2024-12-11

    GE Healthcare CT Systems Recalled Due to Progressive Image Rotation

    GE Healthcare CT systems may display progressively rotated images, particularly in helical, cine, and cardiac scans. Rotations up to 56 degrees may affect image interpretation and could necessitate additional patient scanning.

    Product
    GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0606-2025·2024-12-11

    CT imaging system issue causes progressive image rotation during scans

    GE Healthcare CT systems have a technical issue causing progressive image rotation during helical and cardiac scans. No injuries reported, but unnoticed rotation could affect diagnosis or require rescans.

    Product
    GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0232-2025·2024-12-11

    Sysco Classic Lemonade Drink Mix recalled for metal fragments

    Sysco Classic Lemonade Drink Mix is being recalled due to metal fragments introduced during dextrose production. Consumers should not consume the product and should discard it or return it to their retailer.

    Product
    Sysco Classic Lemonade Drink Mix Natural Flavor, NET WT. 24OZ (1 LB 8 OZ) 690g, UPC 0 74865 09325 5, Case UPC 10074865093252, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077ON, HOUSTON, TEXAS 77077
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·F-0251-2025·2024-12-11

    Apple Wedge Apple Cider Recalled for Elevated Patulin Levels

    Apple Wedge 100% Pasteurized Apple Cider with code C3419 was recalled for containing patulin at 78 ppb, exceeding the FDA limit of 50 ppb. Products were distributed to GA, NC, SC, and FL.

    Product
    No Preservatives 100% CIDER Pasteurized APPLE WEDGE CIDER 1/2 Gal. (1.89L) HENDERSONVILLE, NC 28792 Keep Refrigerated Produce of USA UPC 0 36482 64000 7
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0639-2025·2024-12-11

    Medline Convenience Kits Recalled Due to Defective Smoke Evacuation Component

    Medline is recalling L&D convenience kits distributed nationwide because they were manufactured with smoke evacuation pencils that Stryker subsequently recalled. The affected kits contain components from lot 23HMI048.

    Product
    MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0579-2025·2024-12-11

    Ziehm Vision RFD 3D Hand Switch Defect May Cause Unintended Radiation

    The Ziehm Vision RFD 3D hand switch can fail when exposed to mechanical stress like dropping, potentially initiating unintended radiation from the x-ray system.

    Product
    Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0241-2025·2024-12-11

    Thirster Low Cal Fruit Recalled for Metal Fragment Contamination

    Dyma Brands recalls Thirster Low Cal Fruit due to metal fragments in the product from a damaged sifter during dextrose production. The affected pouches were distributed across 29 states.

    Product
    THIRSTER LOW CAL FRUIT, NET WT. 8.6OZ, Case UPC 50758108397380, DISTRIBUTED BY US FOODS, INC. ROSEMONT, IL 60018
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0629-2025·2024-12-11

    MEDLINE Surgical Convenience Kits Recalled for Defective Smoke Evacuation Pencil Component

    MEDLINE is recalling 102 varieties of surgical convenience kits containing SafeAir Smoke Evacuation Pencils that have been recalled by manufacturer Stryker. The nationwide recall affects 24,754 units.

    Product
    MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184I; 2) ENT MINOR, REF CDS983466L; 3) EAR, REF CDS983486K; 4) HEAD AND NECK, REF CDS984259N; 5) HEAD AND NECK, REF CDS984259O; 6) HEAD & NECK CDS, REF CDS984282L; 7) T & A, REF CDS984895I; 8) T &…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0578-2025·2024-12-11

    Ziehm Vision RFD X-ray System Hand Switch May Cause Unintended Radiation

    Orthoscan's Ziehm Vision RFD fluoroscopic x-ray systems may have wired hand switches that fail under mechanical stress, potentially causing unintended radiation. The manufacturer is recalling affected units in the U.S. and Puerto Rico.

    Product
    Ziehm Vision RFD. Interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0600-2025·2024-12-11

    GE Healthcare CT Systems May Display Rotated Images in Diagnostic Scans

    Certain GE Healthcare CT systems may produce progressively rotated images during diagnostic scans. If undetected and a rescan is needed, the same rotation recurs.

    Product
    GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0618-2025·2024-12-11

    McKesson Calcium Alginate Wound Dressing Recalled for Sterile Barrier Defect

    McKesson Calcium Alginate Dressing Model 3562 is recalled because defects in the primary packaging pouch compromise the sterile barrier. Lot number W00070426 affects approximately 8,000 boxes distributed across Illinois, Texas, and Virginia.

    Product
    McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0590-2025·2024-12-11

    Medical Device: BD MAX System Service Credential Breach Poses Unauthorized Access Risk

    An unauthorized actor accessed service credentials for Becton Dickinson's BD MAX diagnostic systems. Until credentials are updated, there is risk of unauthorized access that may impact data confidentiality, system integrity, and availability.

    Product
    BD MAX System, BD MAX Instrument Version or Model: 441916 Catalog Number: 441916
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0228-2025·2024-12-11

    REJUV ORIGINALS Orange Drink Mix Recalled for Metal Fragments

    DYMA BRANDS is recalling REJUV ORIGINALS Low Calorie Orange Drink Mix due to metal fragments introduced during production. The contaminated product was distributed across 29 states.

    Product
    REJUV ORIGINALS LOW CALORIE ORANGE DRINK MIX NATURAL FLAVOR, NET WT. 8.6 OZ. (244g), UPC 8 22486 14388 6, Case UPC 30822486143887, MARKETED BY INDEPENDENT MARKETING ALLIANCE HOUSTON, TX 77043
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0631-2025·2024-12-11

    Medline Convenience Kits Recalled Due to Defective Component

    Medline Industries is recalling 70 convenience kits containing SafeAir Smoke Evacuation Pencil components that were subsequently recalled by Stryker. The affected product types are General Endoscopy Pack and Endo Bladder Pack.

    Product
    MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44673G; 2) ENDO BLADDER PACK, REF DYNJ49672L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0630-2025·2024-12-11

    Medline Surgical Kits Recalled Due to Defective Smoke Evacuation Component

    Medline is recalling 167,074 surgical convenience kits nationwide containing SafeAir Smoke Evacuation Pencils previously recalled by manufacturer Stryker for use in various surgical procedures.

    Product
    MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS760057K; 3) ABDOMINAL LAPAROSCOPY, REF CDS760057L; 4) MAJOR LAPAROTOMY CDS, REF CDS860015W; 5) MINOR LAPAROTOMY CDS, REF CDS860016P; 6) MINOR LAPAROTOMY CDS, REF CDS860016Q; 7) MINOR LAPAROTOMY CDS, REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0584-2025·2024-12-11

    BD EpiCenter Medical Device Software Service Credentials Accessed by Unauthorized Party

    BD EpiCenter software service credentials were accessed by an unauthorized actor. Until credentials are updated, there is risk of unauthorized access to the software and associated data.

    Product
    BD EpiCenter Single User Software Version or Model: 441007 Catalog Number: 441007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0613-2025·2024-12-11

    GE Healthcare CT Operator Console Images May Rotate During Scans

    GE Healthcare CT systems may produce progressively rotated images during helical, cine, and cardiac scans. Images can rotate up to 56 degrees, potentially requiring patient rescans.

    Product
    GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Discovery RT, Optima CT580, or Discovery CT590 RT; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0079-2025·2024-12-11

    Cinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding FDA Safety Limit

    Aurobindo Pharma USA recalls Cinacalcet 90 mg tablets nationwide due to N-nitroso impurity exceeding FDA's interim safety limit. The impurity is a known carcinogenic compound.

    Product
    Cinacalcet Tablets, 90 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-833-30), b) 500-count HDPE bottle (NDC 65862-833-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India. 90 mg - 30 Tablets - NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0105-2025·2024-12-11

    Duloxetine Delayed-Release Capsules Nationwide Recall for N-Nitroso Impurity

    Rising Pharma recalls Duloxetine Delayed-Release Capsules 20 mg nationwide due to N-nitroso-duloxetine impurity exceeding recommended interim limits, affecting 209,376 bottles.

    Product
    Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0573-2025·2024-12-11

    Mobile C-arm hand switch defect may cause unintended X-ray emission

    Ziehm Solo Digital Mobile C-arm devices may have hand switch defects that can cause unintended radiation emission when exposed to impacts or drops. The recalled units have been distributed in the U.S. and Puerto Rico.

    Product
    Ziehm Solo. Digital Mobile C-arm
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0101-2025·2024-12-11

    Duloxetine Capsules recalled for manufacturing impurity exceeding FDA interim limit

    Amerisource Health Services LLC is recalling 8,561 bottles of Duloxetine Delayed-Release Capsules, 60 mg due to N-nitroso-duloxetine impurity above recommended interim limits. The affected lots were distributed in Pennsylvania, Ohio, and Puerto Rico.

    Product
    Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-0574-2025·2024-12-11

    X-ray system hand switch may fail under mechanical stress

    The Ziehm Solo FD interventional fluoroscopic x-ray system's hand switch may fail when exposed to mechanical stress, potentially causing unintended radiation. Twenty-five units are affected in the U.S. and Puerto Rico.

    Product
    Ziehm Solo FD. Interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0104-2025·2024-12-11

    Sunitinib Malate Capsules Recalled Due to Label Mix-Up

    AvKARE is recalling Sunitinib Malate 25 mg capsules nationwide due to a label mix-up in lot 100049501. The FDA has classified this as a Class II recall.

    Product
    SUNITINIB MALATE — SUNITINIB MALATE (SUNITINIB MALATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·24V923000·2024-12-11

    Suzuki Recalls 2023-2025 Burgman 400 Scooters for Fuel Leak Risk

    Suzuki is recalling 2023-2025 Burgman 400 scooters because a fuel supply hose may contact a vapor hose, causing fuel leaks that increase fire risk.

    Product
    SUZUKI — SUZUKI BURGMAN 400
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0644-2025·2024-12-11

    MEDLINE circumcision kits recalled due to defective smoke evacuation component

    MEDLINE is recalling circumcision kits manufactured with SafeAir Smoke Evacuation Pencils that were previously recalled by Stryker. No injuries have been reported.

    Product
    MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2) D-CIRCUMCISION PACK, REF DYNJ64432; 3) PACK,CIRCUMCISION ASC, REF DYNJ906909A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0097-2025·2024-12-11

    Diltiazem extended-release capsules recalled for manufacturing impurity

    Glenmark Pharmaceuticals is recalling 4,704 bottles of Diltiazem Hydrochloride extended-release capsules 90mg due to manufacturing contamination with an impurity above FDA limits. Two lot numbers distributed nationwide are affected.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0108-2025·2024-12-11

    Cinacalcet Tablets Recalled for Excess Nitrosamine Impurity

    AvKARE is recalling Cinacalcet Tablets 30 mg due to nitrosamine impurity levels exceeding safe limits. Affected bottles nationwide should not be used.

    Product
    Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0576-2025·2024-12-11

    Fluoroscopic X-Ray System Hand Switch May Cause Unintended Radiation

    Orthoscan Inc. is recalling 22 Ziehm Vision FD fluoroscopic x-ray systems. The hand switch may fail when dropped or impacted, potentially initiating unintended radiation exposure.

    Product
    Ziehm Vision FD. Interventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    1 state
  • HighNHTSA·24V921000·2024-12-11

    Gillig Recalls 2023 Low Floor Buses Due to Odometer Defect

    Gillig is recalling 2023 Low Floor diesel-hybrid transit buses because the odometer fails to display mileage in electric mode, potentially delaying critical maintenance.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0090-2025·2024-12-11

    ROYALAB Germ Away Antibacterial Hand Soap Recalled for Failed Microbiological Testing

    Midlab Incorporated is recalling ROYALAB Germ Away Antibacterial Hand Soap (1-gallon, Lot 0711241) due to out-of-specification microbiological test results. The product failed manufacturing quality standards.

    Product
    ROYALAB Germ Away Antibacterial Hand Soap, Chloroxylenol 0.1%, NET CONTENTS: ONE U.S. GALLON (3.78 L), Royal Papers, 2701 Hereford St., St. Louis, MO 63139
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0221-2025·2024-12-11

    Multivitamin supplement recalled for undeclared drugs and aspartame

    Armonia Natural Store LLC is recalling OneMultivitaminic GAF-PLUS Advance 300ml for containing undeclared Acetaminophen, Dexamethasone Phosphate, and Aspartame. Consumers should discontinue use immediately.

    Product
    OneMultivitaminic GAF-PLUS Advance 300ml, plastic bottle, Room Temperature
    Category
    Drug
    Distribution
    12 states
  • HighFDA (Devices)·Z-0610-2025·2024-12-11

    GE Healthcare Revolution Maxima CT Systems Recalled for Progressive Image Rotation

    GE Healthcare recalled Revolution Maxima and related CT imaging systems that can produce progressively rotated images during helical, cine, and cardiac scans. Approximately 72 units worldwide are affected; no patient injuries reported.

    Product
    GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-ray/computed tomography system
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0091-2025·2024-12-11

    Genuine Joe Antibacterial Lotion Soap recalled for manufacturing quality issue

    Midlab Incorporated is recalling Genuine Joe Antibacterial Lotion Soap (Lot 0711241) nationwide due to out-of-specification microbial test results found during manufacturing quality checks.

    Product
    Genuine Joe Antibacterial Lotion Soap , Chloroxylenol 0.1%, 1 GALLON (3.78L), Manufactured in the U.S.A. for S.P. Richards Co., Atlanta, GA 30339
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0100-2025·2024-12-11

    Duloxetine Delayed-Release Capsules Recalled Due to N-nitroso Impurity

    Amerisource Health Services is recalling specific lots of Duloxetine 30 mg capsules due to N-nitroso-duloxetine impurity levels exceeding FDA recommendations. Patients taking affected lots should contact their healthcare provider immediately.

    Product
    Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-0596-2025·2024-12-11

    Medical Device Breach: BACTEC 9240 System Faces Unauthorized Access Risk

    Becton Dickinson recalled the BACTEC 9240 System after unauthorized actors accessed product service credentials. Until credentials are updated, there is risk of unauthorized access that may compromise system security and data integrity.

    Product
    BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0620-2025·2024-12-11

    Olympus Removes Acecide-C Disinfection from GIF-1TH190 Endoscope Reprocessing

    Olympus has removed high-level disinfection with Acecide-C as an approved reprocessing method for the GIF-1TH190 gastrointestinal videoscope. Approximately 1,770 units nationwide are affected.

    Product
    EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0250-2025·2024-12-11

    Cinnamon Apple Cider Recalled for Elevated Patulin Contamination

    Apple Wedge Cinnamon Apple Cider is being recalled due to elevated patulin contamination detected in testing. Affected products were distributed to Georgia, North Carolina, South Carolina, and Florida.

    Product
    Cinnamon Pasteurized APPLE WEDGE CIDER 1/2 Gal. (1.89L) HENDERSONVILLE, NC 28792 Keep Refrigerated Produce of USA Ingredients: Apples, Natural Cinnamon Flavor. 0.1% Potassium Sorbate Added as Preservative UPC 0 36482 64002 1
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-0081-2025·2024-12-11

    Iron sucrose injection recall due to potential glass contamination in vials

    VENOFER (iron sucrose) injection is being recalled nationwide because certain vials may contain glass particles from potential glass delamination. Patients and healthcare providers should contact their pharmacist or healthcare provider immediately.

    Product
    VENOFER — VENOFER (IRON SUCROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0237-2025·2024-12-11

    Sysco Low Cal Lemonade Recalled for Metal Fragments

    DYMA Brands is recalling Sysco Low Cal Lemonade (8.6 oz pouches) due to metal fragments introduced during production. The product was distributed across 29 states.

    Product
    SYSCO LOW CAL LEMONADE, NET WT. 8.6OZ, Case UPC 00734730132648, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
    Category
    Food
    Distribution
    30 states
  • HighFDA (Drugs)·D-0099-2025·2024-12-11

    Duloxetine Delayed-Release Capsules Recalled Due to Manufacturing Quality Deviation

    Amerisource Health Services LLC recalls Duloxetine 20 mg delayed-release capsules due to the presence of N-nitroso-duloxetine impurity above acceptable limits. The affected bottles were distributed in Pennsylvania, Ohio, and Puerto Rico.

    Product
    Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0078-2025·2024-12-11

    Prescription Cinacalcet Tablets Recalled for N-Nitroso Impurity

    Aurobindo Pharma USA Inc is recalling Cinacalcet 60mg tablets nationwide due to N-nitroso Cinacalcet impurity exceeding FDA recommended interim limits.

    Product
    Cinacalcet Tablets, 60mg, packaged in: a) 30-count HDPE bottle (NDC 65862-832-30), b) 500-count HDPE bottle (NDC 65862-832-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0622-2025·2024-12-11

    Medline Tracheostomy Convenience Kits Recalled Due to Defective Component

    Medline is recalling 88 units of tracheostomy convenience kits containing a defective smoke evacuation pencil component that was previously recalled by Stryker. Products were distributed nationwide.

    Product
    MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TRACHEOSTOMY, REF DYNJ902123J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0096-2025·2024-12-11

    Prescription Drug Diltiazem Hydrochloride Recalled for Manufacturing Impurity

    Glenmark Pharmaceuticals is recalling 5,232 bottles of Diltiazem Hydrochloride Extended-Release Capsules nationwide due to an impurity that exceeds FDA safety limits. Patients currently taking this medication should contact their pharmacist or doctor.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0640-2025·2024-12-11

    MEDLINE convenience kits recalled due to defective component

    Medline is recalling multiple lots of its convenience kits because they contain a component (SafeAir Smoke Evacuation Pencil) that was previously recalled by Stryker. The affected kits are distributed nationwide.

    Product
    MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC NEURO PACK, REF CDS780202Q; 3) BASIC NEURO PACK, REF CDS780202R; 4) ACDF CDS, REF CDS941061M; 5) NEURO KIT, REF CDS981327Q; 6) ZALE V-P SHUNT CDS, REF CDS983186J; 7) NEURO PACK-LF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0112-2025·2024-12-11

    Prescription Drug Lisdexamfetamine Dimesylate Recalled for Failed Content Uniformity

    Lannett Company is recalling 1,608 bottles of Lisdexamfetamine Dimesylate 10 mg capsules nationwide due to failed content uniformity. The active ingredient may be unevenly distributed in some capsules.

    Product
    LISDEXAMFETAMINE DIMESYLATE — LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0575-2025·2024-12-11

    X-ray system hand switch may fail, risking unintended radiation exposure

    Three Ziehm Vision x-ray systems have hand switches that may fail under mechanical stress, potentially causing unintended radiation. Owners should verify their serial numbers and contact the manufacturer.

    Product
    Ziehm Vision system, x-ray, tomography, computed.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0628-2025·2024-12-11

    MEDLINE dental and oral surgery kits recalled due to defective component

    MEDLINE is recalling four types of dental and oral surgery convenience kits that were manufactured using SafeAir Smoke Evacuation Pencils, which were previously recalled by Stryker.

    Product
    MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ52404I; 2) ORL PACK, REF DYNJ59073B; 3) ORAL MAXILOFACIAL PK, REF DYNJ80226A; 4) DENTAL MINOR PACK, REF DYNJ83140
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0617-2025·2024-12-11

    Hollister CalciCare Calcium Alginate Dressing Recalled for Packaging Defect

    Advanced Medical Solutions is recalling Hollister CalciCare Calcium Alginate Dressing (Model 529937R, Lot W00070134) due to defects in the primary packaging pouch that compromise sterile barrier integrity. The affected dressing was distributed nationwide to IL, TX, and VA.

    Product
    Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acute wounds such as: ¿ pressure ulcers ¿ leg ulcers ¿ cavity wounds ¿ lacerations ¿ post-operative surgical wounds
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0626-2025·2024-12-11

    Medline recalls surgical convenience kits with defective smoke evacuation component

    Medline is recalling five types of medical convenience kits because they contain the SafeAir Smoke Evacuation Pencil, which Stryker subsequently recalled.

    Product
    MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VASCULAR ACCESS PACK-LF, REF DYNJ0101291F; 3) MAJOR VASCULAR PACK-LF, REF DYNJ0488546K; 4) PEDS CENTRAL LINE PACK, REF DYNJ84762; 5) PACK,CENTRAL LINE, REF DYNJ906907C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0110-2025·2024-12-11

    Cinacalcet Tablets Recalled Due to Nitrosamine Impurity Exceeding Limits

    AvKARE is recalling 2,796 bottles of Cinacalcet Tablets (90 mg) nationwide due to manufacturing deviations resulting in N-Nitroso-Cinacalcet above acceptable intake limits.

    Product
    Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0252-2025·2024-12-11

    Jose Madrid Salsa Recalled for Undeclared Yellow Food Colorants

    Jose Madrid Salsa Chipotle Con Queso is being recalled because it contains undeclared Yellow #5 and Yellow #6 food colorants. These additives must be labeled and can trigger sensitivities in some consumers.

    Product
    Jose Madrid Salsa Chipotle Con Queso, Net Wt. 13 oz. (369g), packaged in glass jars; 12 jars per case
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-0598-2025·2024-12-11

    Cartiva Synthetic Cartilage Implants Recalled Due to Higher Complication Rates

    Cartiva Synthetic Cartilage Implants are being recalled due to higher-than-expected rates of complications including implant displacement, subsidence, nerve damage, and fragmentation. Patients with these implants should consult their surgeon.

    Product
    Cartiva Synthetic Cartilage Implant (SCI) Catalog: CAR-06-US (6mm), CAR-08-US (8mm), CAR-10-US (10mm), CAR-12-US (12mm)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0243-2025·2024-12-11

    Member's Mark Roasted Red Pepper Hummus Recalled for Potential Foreign Objects

    Cedar's Mediterranean Foods is recalling Member's Mark Roasted Red Pepper Hummus due to potential presence of foreign objects. The recall affects 23,136 units distributed to retail locations in ten states.

    Product
    Member's Mark brand Roasted Red Pepper Hummus; 32 oz (907 g) Plastic Container with UPC# 193968044268
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-0583-2025·2024-12-11

    Spectral CT Devices Pose Collision and Misdiagnosis Software Risks

    Philips Spectral CT and Spectral CT Plus devices may fail to update plan positioning during interventional procedures, creating collision risks to operators and patients. A software defect may also assign incorrect patient IDs, potentially causing misdiagnosis.

    Product
    Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0597-2025·2024-12-11

    Siemens Atellica CI Analyzer may produce falsely elevated electrolyte test results

    Siemens' Atellica CI Analyzer may display incorrect diluent volume levels, causing falsely elevated sodium, potassium, and chloride test results in 559 units distributed worldwide.

    Product
    Atellica CI Analyzer. Catalog Numbers: 10947347.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0593-2025·2024-12-11

    BD BACTEC FX Instrument Top credential compromise enables unauthorized access risk

    BD service credentials for BACTEC FX instruments were accessed by an unauthorized actor, creating risk of unauthorized system access until credentials are updated.

    Product
    BD BACTEC FX, Instrument Top, Packaged Version or Model: 441385 Catalog Number: 441385
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0577-2025·2024-12-11

    Fluoroscopic X-ray System Hand Switch May Fail and Cause Unintended Radiation

    The Ziehm Vision R fluoroscopic x-ray system has a hand switch that may fail under mechanical stress and cause unintended radiation. Ziehm Imaging, Inc. is recalling 5 affected units distributed in the U.S.

    Product
    Ziehm Vision R. Iterventional fluoroscopic x-ray system
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0238-2025·2024-12-11

    Sysco Pink Lemonade Recalled Due to Metal Fragment Contamination

    Sysco Pink Lemonade 24-ounce pouches are being recalled due to potential metal fragment contamination from a damaged sifter during production. The product was distributed to 29 states.

    Product
    SYSCO PINK LEMONADE, NET WT. 24OZ, UPC 0 74865 09326 2, Case UPC 10074865093269, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0627-2025·2024-12-11

    Medline Medical Device Kits Recalled Due to Defective SafeAir Component

    Medline is recalling 980 units of medical convenience kits manufactured using SafeAir Smoke Evacuation Pencil components that Stryker previously recalled. The kits were distributed nationwide.

    Product
    MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BREAST BIOPSY PACK-LF, REF DYNJ0842590G; 3) TREATMENT ROOM PACK, REF DYNJ41473G; 4) TREATMENT ROOM PACK, REF DYNJ41473I; 5) BREAST BIOPSY PACK, REF DYNJ44148G; 6) PRX BREAST PACK…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0089-2025·2024-12-11

    Array Liquid Antiseptic Handwash Recalled for Microbiological Test Failures

    Midlab Incorporated is recalling Array Liquid Antiseptic Handwash due to manufacturing quality deviations. The product failed microbiological testing and may not provide adequate antimicrobial protection.

    Product
    Array Liquid Antiseptic Handwash, Chloroxylenol 0.1%, NET CONTENTS: 128 FL OZ (1 GAL) 3.785 L, FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE, WYOMING, MI 49509
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0229-2025·2024-12-11

    Pink Lemonade Drink Mix Recalled for Metal Fragment Contamination

    REJUV ORIGINALS pink lemonade drink mix is being recalled due to metal fragments introduced during production. The contamination resulted from a damaged sifter used in dextrose processing.

    Product
    REJUV ORIGINALS PINK LEMONADE DRINK MIX NATURAL FLAVOR, NET WT. 24OZ. (680g), UPC 8 22486 11808 2, Case UPC 30822486118083, MARKETED BY INDEPENDENT MARKETING ALLIANCE HOUSTON, TX 77043
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·F-0234-2025·2024-12-11

    Sysco Classic Strawberry Drink Mix recalled for metal fragment contamination

    Sysco Classic Strawberry Drink Mix is being recalled due to metal fragments discovered during production. A damaged sifter in dextrose processing introduced the contamination into the product.

    Product
    Sysco Classic Strawberry Drink Mix Artificial Flavor, NET WT. 24OZ (1 LB 8 OZ) 690g, UPC 0 74865 09328 6, Case UPC 10074865093283, DISTRIBUTED BY SYSCO CORPORATION, HOUSTON, TEXAS 77077
    Category
    Food
    Distribution
    30 states

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