The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

76–100 of 32222

  • SevereFDA (Drugs)·D-0017-2027·2026-10-14

    FDA Recalls Tirzepatide Injectable Due to Sterility Concerns

    Carolina Infusion, LLC is recalling Tirzepatide 26 mg/mL injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.

    Product
    TIRZEPATIDE 26 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936;
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0074-2027·2026-10-14

    Steris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns

    Steris Corporation is recalling 217 VERIFY Biological Steam Test Packs because the spore population may fall below specifications, potentially causing false sterilization results.

    Product
    VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0025-2027·2026-10-14

    FDA Recalls Tri-MIX Injectable Due to Sterility Concerns

    Carolina Infusion, LLC is recalling Tri-MIX injectable syringes because processing equipment used in compounding raised concerns about the product's sterility.

    Product
    Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/60, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0007-2027·2026-10-14

    K.C. Pharmaceuticals Recalls Good Sense Eye Drops for Sterility Concerns

    K.C. Pharmaceuticals is recalling Good Sense Eye Drops Original Formula due to a lack of assurance of sterility. The recall affects 1,025,448 cartons distributed nationwide.

    Product
    GOODSENSE EYE DROPS ORIGINAL FORMULA — GOODSENSE EYE DROPS ORIGINAL FORMULA (TETRAHYDROZOLINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0081-2027·2026-10-14

    Safeguard US Operating LLC Recalls Compression Bandages Due to Degradation

    Safeguard US Operating LLC is recalling 46,881 units of compression bandages and trauma kits because the bandages may be degraded, posing a risk of introducing foreign material into wounds.

    Product
    Battle Bandage, REF: 32-700; Patrol IFAK Bag, Black - Advanced, REF: 81-125-BL; Patrol IFAK Bag, Multicam - Advanced, REF: 81-125-MC; Patrol IFAK II, Olive Drab, Stocked (Option 1), 81-129-OD; IFAK Bag, Intermediate, Black - Stocked, 81-133-BL; IFAK Bag, Intermediate…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0087-2027·2026-10-14

    Medline Bariatric Rollator Recalled Due to Front Wheel Assembly Disconnect Risk

    Medline is recalling 835 bariatric rollators because the front wheel assembly may disconnect from the frame, posing a risk of falls and severe injuries.

    Product
    Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide moderate weight support while walking, Product Number MDS86800XWBS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·N/A·2026-10-14

    White Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient

    Shaman Botanicals, LLC is recalling White Vein Advanced Alkaloids Chewable Tablets because testing found the active ingredient 7-hydroxymitragynine is present in a quantity greater than the labeled specification.

    Product
    SIERRA NEVADA CHEESE GRAZIERS RAW MILK SHARP CHEDDAR NET WT. 40 LBS Item 6516
    Category
    Food
    Distribution
    41 states
  • SevereFDA (Devices)·Z-0119-2027·2026-10-14

    Intellijoint Navigation Systems Recalled for Potential Fire Risk

    Intellijoint Surgical is recalling eight navigation systems because their workstations may contain a defective Apple battery that could overheat and cause a fire.

    Product
    Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0075-2027·2026-10-14

    Steris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect

    Steris Corporation is recalling VERIFY Biological Steam Test Packs because the spore population may fall below specifications, potentially causing false-negative steam sterilization results.

    Product
    VERIFY Biological Steam Test Pack Model/Catalog Number: S3069
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0032-2027·2026-10-14

    FDA Recalls Tri-MIX Syringes Due to Sterility Assurance Concerns

    Carolina Infusion, LLC is recalling Tri-MIX compounded syringes due to a lack of assurance of sterility related to formulation and processing equipment.

    Product
    Tri-MIX (PAPAV/PHENTO/ALPROS),30/2/40, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0072-2027·2026-10-14

    Steris VERIFY Biological Indicator Recall Due to Spore Population Concerns

    Steris is recalling VERIFY Dual Species Self-Contained Biological Indicators because spore populations may fall below specifications, potentially leading to false sterilization results.

    Product
    VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0004-2027·2026-10-14

    K.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns

    K.C. Pharmaceuticals is recalling Leader Advanced Relief Eye Drops and related brands due to a lack of assurance of sterility. The recall covers 208,896 cartons distributed nationwide.

    Product
    LEADER ADVANCED RELIEF EYE DROPS — LEADER ADVANCED RELIEF EYE DROPS (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0037-2027·2026-10-14

    Apothecary NAD+ Injection Recalled for Lack of Sterility Assurance

    Apothecary Pharma is recalling NAD+ Injection vials due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Apothecary NAD+ Injection 200 mg/mL, 6 mL Sterile Multi-Dose Vial, Rx Only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, NC, 27513, NDC 85091-011-06.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0108-2027·2026-10-14

    Canon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk

    Canon Medical System is recalling one Alphenix INFX-8000C/B5 unit in Idaho due to a risk of tabletop shifting that could cause patient misalignment.

    Product
    Alphenix INFX-8000C/B5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V673000·2026-10-14

    Toyota Recalls Land Cruiser Hybrid Vehicles for Fuel Leak Risk

    Toyota is recalling 2024-2027 Land Cruiser Hybrid vehicles because a fuel tube connection may disconnect and leak fuel, increasing fire risk.

    Product
    TOYOTA — TOYOTA LAND CRUISER HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0011-2027·2026-10-14

    Better Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk

    The Better Bakehouse Snack Company is recalling Donutful Chocolate Dipped Vanilla Cake Donuts due to undeclared milk. The product was distributed nationwide.

    Product
    Donutful Chocolate Dipped Vanilla Cake Donuts - 7.05oz/10ct.Case Configuration 5 count carton, 6 cartons per case. UPC 850041392103. Paperboard carton containing 5 individually wrapped packages of two donuts each. UPC: 850041392103. The Better Bakehouse Snack Co. 3651 Lindell…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0020-2027·2026-10-14

    Sweet Sensi THC Gum Drops Recalled for Staphylococcus aureus

    Sweet Sensi is recalling Passion Guava Kush THC gum drops nationwide due to the detection of Staphylococcus aureus.

    Product
    Sweet Sensi Elevated Edibles Hybrid Gum Drops - Passion Guava Kush 140mg THC. Product is packaged in sealable & flexible gold, purple and black metallic plastic mylar pouch and is sold in two sizes: 1) Net wt. Approx. 2.1oz (60g) 10 count and 2) Net wt. 6.3oz (180g) 30 count.…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0029-2027·2026-10-14

    FDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns

    Carolina Infusion, LLC is recalling Tirzepatide/Cyanocobalamin 76/2 mg/mL injectable syringes due to a lack of assurance of sterility related to formulation and processing equipment.

    Product
    TIRZEPATIDE/CYANOCOBALAMIN 76/2 MG/ML INJECTABLE, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0005-2027·2026-10-14

    K.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns

    K.C. Pharmaceuticals is recalling multiple brands of eye drops due to a lack of assurance of sterility. The recall covers 1,435,830 cartons distributed nationwide.

    Product
    TARGET EYE DROPS MAXIMUM REDNESS RELIEF EYE — TARGET EYE DROPS MAXIMUM REDNESS RELIEF EYE (GLYCERIN, NAPHAZOLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0014-2027·2026-10-14

    GIAS Food Inc. Recalls Lemon Alfredo Fettuccine for Listeria Contamination

    GIAS Food Inc. is recalling 1,174 cases of Lemon Alfredo Fettuccine due to contamination with Listeria monocytogenes. The product was distributed to retail locations nationwide.

    Product
    Lemon Alfredo Fettuccine packed in a yellow plastic sealed bag with pink and black lettering; label reads in part as "bettergoods Lemon Alfredo Fettuccine, MADE IN ITALY, NET WT 22 OZ, BEST if Used By: SEP 21 2027 L6081A, UPC 194346442706, DISTRIBUTED BY: Walmart Inc.…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0079-2027·2026-10-14

    Cardinal Health Recalls Presource Packs with Medtronic Microstream Components

    Cardinal Health 200, LLC is recalling 210 Presource Packs containing Medtronic Microstream components due to reports of difficulty disconnecting the adapter, which can cause treatment delays or unintended extubation.

    Product
    Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J Intubating Bag Kit Catalog Number OMSVM4166A Intubation UH Kit Catalog Number AN2336608G
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0107-2027·2026-10-14

    Polymedco Sediplast Tubes Recalled for Potential Blood Exposure

    Polymedco is recalling Sediplast tubes because pressure buildup may eject the cap, releasing blood and creating a biological hazard for operators.

    Product
    SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0023-2027·2026-10-14

    FDA Recalls Tri-MIX Injectable Due to Sterility Concerns

    Carolina Infusion, LLC is recalling Tri-MIX injectable syringes due to a lack of assurance of sterility related to processing equipment.

    Product
    Tri-MIX (PAPAV/PHENTO/ALPROS),30/1/10, injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specific patient prescription, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0085-2027·2026-10-14

    Stryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach

    Stryker is recalling Bard EP XT Decapolar Steerable Diagnostic EP Catheters due to a potential sterile barrier breach that could lead to particulate embolization, infection, or thrombus formation.

    Product
    BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 201007
    Category
    Medical Device
    Distribution
    Distributed nationwide