The Recall Desk

Archive

January 2026 recalls

393 recalls were announced in January 2026.

What the numbers show

Critical
39
Severe
30
High
204
Moderate
113
Low
7

Of the 393 recalls this month scored against our rubric, 10% are Critical, 8% are Severe.

1–100 of 393

  • SevereNHTSA·26V058000·2026-01-30

    Grand Design motorhome front seat bases may be improperly tightened

    Grand Design is recalling certain 2025-2026 Lineage motorhomes because the seat base on the driver and front passenger seat may have been improperly tightened. This fails FMVSS 207.

    Product
    GRAND DESIGN — GRAND DESIGN LINEAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V056000·2026-01-30

    BMW and Toyota Supra engine starters may overheat and catch fire

    BMW is recalling certain 2021-2024 BMW models and 2021-2023 Toyota Supra vehicles because the engine starter may overheat and catch fire due to wear on an internal component.

    Product
    BMW — BMW, TOYOTA 430I, Z4, 330I, 530I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V057000·2026-01-30

    Grand Design Recalls 2026 Solitude RVs for Fire Risk

    Grand Design is recalling 2026 Solitude recreational vehicles because a water tank heating pad may fail, increasing the risk of a fire.

    Product
    GRAND DESIGN — GRAND DESIGN LINEAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V054000·2026-01-29

    Honda driver seat cushion frame may not have been tightened properly

    Honda is recalling certain 2023 Accord and Accord Hybrid, 2024 HR-V and Pilot, and Acura Integra vehicles because the driver's seat cushion frame may not have been tightened properly.

    Product
    HONDA — HONDA, ACURA ACCORD HYBRID, INTEGRA, ACCORD, HR-V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V051000·2026-01-29

    Jeep Grand Cherokee rear coil springs may detach while driving

    Chrysler is recalling certain 2021-2023 Jeep Grand Cherokee L and 2022-2023 Grand Cherokee vehicles because the rear coil springs may be incorrectly installed and detach from the vehicle while driving.

    Product
    JEEP — JEEP GRAND CHEROKEE, GRAND CHEROKEE L
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·26219·2026-01-29

    Pull string teething toys recalled after fifteen reported choking incidents

    About 49,410 AiTuiTui Pull String Teething Toys are being recalled. CPSC is aware of 15 choking incidents and two incidents of children able to bite pieces off the silicone strings.

    Product
    AiTuiTui Pull String Teething Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·26227·2026-01-29

    Above-ground pools recalled over a compression strap that creates a foothold

    About 2,390 Sunneday and Blue Bay above-ground pools 48 inches and taller are being recalled because the compression strap around the pool legs may let a child climb in.

    Product
    Sunneday and Blue Bay brand 48-inch and taller above-ground pools
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·26226·2026-01-29

    Plush giraffe and llama toys recalled over legs that can detach

    About 21,230 Giraffe and Llama plush toys with clips sold at Hobby Lobby are being recalled because the legs can detach and release small beads.

    Product
    Giraffe Plush Toy with clip, Llama Plush Toy with clip
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·26220·2026-01-29

    Electric bicycle rear wheel bolts recalled over breakage when torqued

    About 19,890 rear wheel bolts on 2026 Trek FX+ 1 and Electra Townie Go! electric bicycles are being recalled because the bolts can break when torqued, causing wheel separation.

    Product
    Rear wheel bolts installed on model year 2026 Trek FX+ 1 and Electra Townie Go! electric bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·26218·2026-01-29

    Hot water pressure washers recalled over fan wheels that can fail

    About 1,416 NorthStar hot water pressure washers are being recalled because the fan wheel can fail, causing abnormal burner operation that can produce smoke or bursts of flames.

    Product
    Sefudun Hair Growth Serum Kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·26221·2026-01-29

    Multivitamin bottles recalled over caps that are not child-resistant

    About 148,370 Mindbodygreen Ultimate Multivitamin+ bottles are being recalled because the packaging holding iron-containing supplements is not child-resistant.

    Product
    Ultimate Multivitamin+ Dietary Supplement Bottles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·26222·2026-01-29

    Submersible LED lights recalled over accessible lithium coin batteries

    About 9,150 LuxJet Submersible LED Lights are being recalled because the lithium coin batteries can be accessed easily by children and the lights lack the warnings required by Reese's Law.

    Product
    LuxJet Submersible LED Lights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·26V052000·2026-01-29

    Winnebago Recalls 2026 Access Travel Trailers for Missing Weight Label

    Winnebago is recalling 2026 Access travel trailers because the Gross Axle Weight Rating may be missing from the certification label, which could lead to overloading.

    Product
    WINNEBAGO — WINNEBAGO ACCESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·26236·2026-01-29

    Cargo electric bicycles recalled over buckles that may not latch

    About 320 Urban Arrow FamilyNext Pro Cargo E-Bikes are being recalled because the Fidlock buckle can fail to fully latch when used with children in the cargo area.

    Product
    Urban Arrow FamilyNext Pro Cargo E-Bikes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·26230·2026-01-29

    Glow-in-the-dark crayon sets recalled over high strontium and aluminum levels

    About 600 Primark The Nightmare Before Christmas Glow-in-the-Dark Coloring Sets are being recalled because the crayons have high levels of strontium and aluminum.

    Product
    Primark The Nightmare Before Christmas Glow-in-the-Dark Coloring Set
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1012-2026·2026-01-28

    Semi electric lightweight homecare beds recalled over pendants that may overheat

    Medline is recalling 13,245 Semi Electric Lightweight Homecare Beds because the hand control pendant and its cords may overheat and, in rare instances, pose a risk of fire.

    Product
    MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L
    Category
    Medical Device
    Distribution
    4 states
  • CriticalFDA (Food)·H-0407-2026·2026-01-28

    Barbecue and dip sauce recalled over undeclared fish from Worcestershire

    Anthony's BBQ is recalling 192 bottles of Anthony's Barbecue & Dip-It Sauce because the label does not declare Worcestershire, which contains anchovy.

    Product
    Anthony's Barbecue & Dip-It Sauce, 15 oz. (425g) glass bottle, UPC 6 89076 62272 1. Anthony's BBQ Sauce PO Box 3239 Harbor, OR 97415. The ingredients statement on the recalled bottle is declared as "***Ingredients: Tomatoes, Brown Sugar, Distilled Water, Distilled Vinegar, Garli
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Devices)·Z-1013-2026·2026-01-28

    Full electric basic homecare beds recalled over pendants that may overheat

    Medline is recalling 138,412 units of the Full Electric Basic Homecare Bed because the hand control pendant and its cords may overheat and, in rare instances, pose a risk of fire.

    Product
    MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full Electric Basic Homecare Bed, 4-pack,REF MDR107003E-4.
    Category
    Medical Device
    Distribution
    4 states
  • CriticalFDA (Devices)·Z-1147-2026·2026-01-28

    Full electric lightweight homecare beds recalled over pendants that may overheat

    Medline is recalling 35,694 units of the Full Electric Lightweight Homecare Bed because the hand control pendant and its cords may overheat and, in rare instances, pose a risk of fire.

    Product
    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of multiple physiological parameters, including ECG, respiration (RESP), non-inv
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1016-2026·2026-01-28

    Full electric low lightweight homecare beds recalled over overheating pendants

    Medline is recalling 15,581 units of the Full Electric Low Lightweight Homecare Bed because the hand control pendant and its cords may overheat and, in rare instances, pose a risk of fire.

    Product
    MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR107003LO
    Category
    Medical Device
    Distribution
    4 states
  • CriticalFDA (Devices)·Z-1014-2026·2026-01-28

    Full electric low homecare beds recalled over hand pendants that overheat

    Medline is recalling 22,565 units of the Full Electric Low Basic Homecare Bed because the hand control pendant and its cords may overheat and, in rare instances, pose a risk of fire.

    Product
    MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO
    Category
    Medical Device
    Distribution
    4 states
  • CriticalFDA (Devices)·Z-1102-2026·2026-01-28

    Frozen cookie dough recalled over undeclared peanuts in white chocolate macadamia

    Gregory's Foods is recalling 308 cases of Bag Full of Cookies White Chocolate Macadamia Nut frozen cookie dough over undeclared peanuts.

    Product
    RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·26V050000·2026-01-28

    Ducati motorcycle rear brake hose may fail from excessive heat

    Ducati is recalling certain 2025-2026 Streetfighter V4 and Panigale V4 motorcycles because excessive heat may damage the rear brake hose, resulting in a sudden loss of the rear brakes.

    Product
    DUCATI — DUCATI PANIGALE V4 S, STREETFIGHTER V4 S, PANIGALE V4, STREETFIGHTER V4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1125-2026·2026-01-28

    Waste management vascular trays recalled over inflation handles that may detach

    Merit Medical Systems is recalling 864 units of its Custom Waste Management Kit Vascular Tray because the inflation device handle may detach from the syringe during a procedure.

    Product
    Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1108-2026·2026-01-28

    RayStation 2024A treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 15.2.0 and 15.1.3 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1107-2026·2026-01-28

    Blood transfusion filters recalled over unconfirmed sterility assurance before release

    GVS TM is recalling 2,720 SQ40S Blood Transfusion Filters from one lot because they were released for distribution before the required quality control release process was completed.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1135-2026·2026-01-28

    LDL cholesterol assays recalled over triglyceride interference causing biased results

    Beckman Coulter is recalling 34,451 units of the LDL Cholesterol OSR6x96 assay because triglyceride interference may cause a positive bias of up to 28.8% in low LDL cholesterol samples.

    Product
    The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a c
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1110-2026·2026-01-28

    RayStation v2025 treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 17.0.0 and 17.0.1 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1113-2026·2026-01-28

    Azurion imaging systems recalled over two software issues affecting imaging

    Philips is recalling 228 Azurion systems on software version R3.1 over two software issues that may result in loss of imaging, loss of motorized movement, incorrect image content or loss of data.

    Product
    Philips Azurion system; Software Version Number: R3.1;
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·H-0411-2026·2026-01-28

    All human food products from one distributor recalled over rodent activity

    Gold Star Distribution is recalling all human food products distributed from the firm over potential exposure of rodents and rodent activity in the distribution center.

    Product
    All human food products distributed from the firm. Including but not limited to: snack foods, candy, gum, cooking oil, canned fruit and beans, honey, Dietary supplements, peanut butter, oatmeal, rice, dry peas and beans, ramen, cold cereal, hot sauce, lemon juice, crackers, can
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1015-2026·2026-01-28

    Red lentil dal soup recalled over undeclared milk and wrong contents

    Bakkavor is recalling 291 cases of H-E-B Meal Simple Red Lentil Dal Soup over undeclared milk, with the record citing the wrong product in the container.

    Product
    MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·H-0415-2026·2026-01-28

    RayStation 10B treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan model 10.1 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Mini Gaceniga Authentic Cuban Loaf Cake Classic (Net Wt. 12 oz (340g)) packaged in wax paper, placed in clear bag and packed in cardboard carton. 12/ 12 oz per master case.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1124-2026·2026-01-28

    Angiographic inflation devices recalled over handles that may detach

    Merit Medical Systems is recalling 173,645 units of the Allwell Inflation Device because the inflation device handle may detach from the syringe during a procedure.

    Product
    Allwell Inflation Device, for angiographic use REF: IS-30-A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1106-2026·2026-01-28

    RayStation 2023B and 2024A recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 14.0.0, 15.0.0 and 15.1.3 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1157-2026·2026-01-28

    RayStation 10B SP1 recalled over radiation dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan model 10.1.1 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    SQ40S Blood Transfusion Filter
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-1145-2026·2026-01-28

    Endoluminal vision probe bags recalled over compromised sterile pouch seals

    Intuitive Surgical is recalling 110,580 Ion Vision Probe Bags because the probe bags may have a compromised or incomplete sterile pouch seal.

    Product
    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1104-2026·2026-01-28

    RayStation 11B treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 12.0.0, 12.1.0, 12.0.3, 12.0.4 and 12.3.0 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1. Radiation Therapy Treatment Planning System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0295-2026·2026-01-28

    Icosapent ethyl capsules recalled as subpotent after capsule contents leaked

    Zydus Pharmaceuticals is recalling 22,896 bottles of Icosapent Ethyl capsules, 1 gram, because oxidation caused by leakage of the capsule contents has left them subpotent.

    Product
    Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1123-2026·2026-01-28

    basixCOMPAK inflation devices recalled over handles that may detach

    Merit Medical Systems is recalling 4,163,123 units of the Merit Medical Inflation Device basixCOMPAK because the inflation device handle may detach from the syringe during a procedure.

    Product
    Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1011-2026·2026-01-28

    Convertible baby gyms recalled over floor mats that can obstruct breathing

    About 500 Mikario Trading 5-in-1 convertible baby gyms are being recalled because the floor mats can obstruct an infant's breathing.

    Product
    MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E; 2) Semi Electric Basic Homecare Bed, 4-pack,REF MDR107002E-4
    Category
    Consumer Product
    Distribution
    4 states
  • HighFDA (Devices)·Z-1111-2026·2026-01-28

    Needle free access connectors recalled over silicone seals that may tear

    ICU Medical is recalling 14,684,607 Tego Connectors because the silicone seal may bulge, separate from the body or tear, which can cause fluid leaks, occluded flow or air infused into the body.

    Product
    Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26V049000·2026-01-28

    Toyota Prius models recalled for unexpected rear door opening risk

    Toyota is recalling certain 2023–2026 Prius and Prius Prime models because water may enter the rear door switch, causing an unlocked door to open unexpectedly while driving. This increases injury risk.

    Product
    TOYOTA — TOYOTA PRIUS PRIME, PRIUS, PRIUS PLUG-IN HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1112-2026·2026-01-28

    PET scanners recalled over a streaking artifact in clinical images

    GE HealthCare is recalling 364 Omni Legend PET systems because an intermittent issue can produce a streaking artifact in PET clinical scan images.

    Product
    GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1105-2026·2026-01-28

    RayStation 12A treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 13.0.0.1547, 13.1.0.144 and 13.1.1.89 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, RayStation 12A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·H-0413-2026·2026-01-28

    Custom manifold kits recalled over inflation handles that may detach

    Merit Medical Systems is recalling 2,192 Custom Manifold Kits, REF K09-13203A, because the inflation device handle may detach from the syringe during a procedure.

    Product
    Gaceniga Authentic Cuban Loaf Cake Raisins (Net Wt. 24 oz (680g)) packaged in wax paper placed in clear bag and packed in cardboard carton. 12/ 24 oz per master case.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Drugs)·D-0294-2026·2026-01-28

    Bulk thyroid drug substance recalled as subpotent from one lot

    Specialty Process Labs is recalling one lot of Thyroid, USP bulk drug substance because it is subpotent.

    Product
    Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1129-2026·2026-01-28

    Angioplasty packs recalled over inflation handles that may detach

    Merit Medical Systems is recalling 328,000 units of the Allwell Angioplasty Pack because the inflation device handle may detach from the syringe during a procedure.

    Product
    Allwell Angioplasty Pack REF: IS-30-B1/B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1128-2026·2026-01-28

    Custom procedure kits recalled over inflation handles that may detach

    Merit Medical Systems is recalling its Custom Procedure Kit because the inflation device handle may detach from the syringe during a procedure.

    Product
    Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1109-2026·2026-01-28

    RayStation 2024B treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan model 16.0.0 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning System Component: No
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1103-2026·2026-01-28

    RayStation 11A treatment planning recalled over dose that fails to invalidate

    RaySearch Laboratories is recalling RayStation/RayPlan models 11.0.0, 11.0.1, 11.0.3 and 11.0.4 because calculated radiation dose is not invalidated as intended for certain regions of interest.

    Product
    RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiation Therapy Treatment Planning System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1121-2026·2026-01-28

    SIGMA Spectrum infusion pumps recalled over defective grease on the gears

    Baxter Healthcare is recalling 585 SIGMA Spectrum Infusion Pumps because defective grease on the cam and motor gears could lead to over-infusion or a free-flow situation.

    Product
    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1126-2026·2026-01-28

    Custom inflation kits recalled over inflation handles that may detach

    Merit Medical Systems is recalling 18,897 units of its Custom Inflation Kit because the inflation device handle may detach from the syringe during a procedure.

    Product
    Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1156-2026·2026-01-28

    Patient information centers recalled over a patch changing notification filters

    Philips North America is recalling 146 Patient Information Center iX units because a software patch modifies Mobile Event Notification filter settings without any indication to the user.

    Product
    Patient Information Center iX; Software Version Number: 4.5.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1120-2026·2026-01-28

    Plum Solo pumps recalled over hard limit messages blocking flush programming

    ICU Medical is recalling the Plum Solo Precision IV Pump because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.

    Product
    ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1152-2026·2026-01-28

    M3B vital signs monitors recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 354 units of its M3B Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1132-2026·2026-01-28

    Long distal radius plates recalled over an incorrect thread orientation

    Tyber Medical is recalling 64 units VOLT Wrist Treatment System distal radius plates because the supplier manufactured anatomical left plates with an incorrect thread orientation.

    Product
    Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 02.426.691S Product Description: 2 Column Distal Radius Plate - 6 Head, 14 Shaft, Standard Left - 186mm Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1137-2026·2026-01-28

    TRAM powered lift devices recalled over potential strap fraying

    Community Products is recalling 3,238 units of the Rifton TRAM over potential fraying on the body support strap.

    Product
    Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1139-2026·2026-01-28

    Gait training devices recalled over potential fraying on the body support strap

    Community Products is recalling 470 units of the Rifton E-Pacer gait training device over potential fraying on the body support strap.

    Product
    Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjustment that facilitates the sit-to-stand motion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1155-2026·2026-01-28

    Telemetry transmitters recalled over potential cybersecurity issues flagged by FDA

    Edan Diagnostics is recalling 1,457 units of its iT20 Telemetry Transmitter after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyzing and processing. After that, data will be sent to MFM-CMS via Wi-Fi. The para
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1149-2026·2026-01-28

    iX series patient monitors recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 379 units of its Patient Monitor models iX10, iX12 and iX15 after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0291-2026·2026-01-28

    Diclofenac topical gel recalled after failing pH specifications

    Cipla USA is recalling 92,376 tubes of Diclofenac Sodium Topical Gel 1% after the batch failed pH specifications.

    Product
    DICLOFENAC SODIUM — DICLOFENAC SODIUM (DICLOFENAC SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0414-2026·2026-01-28

    Infusion pumps recalled over hard limit messages blocking piggyback flush programming

    ICU Medical is recalling Plum Duo Precision IV Pumps because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.

    Product
    Mini Gaceniga Authentic Cuban Loaf Cake Raisins (Net Wt. 12 oz (340g)) packaged in wax paper, placed in clear bag and packed in cardboard carton. 12/ 12 oz per master case.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·H-0412-2026·2026-01-28

    Classic Cuban loaf cake recalled over undeclared FD&C Yellow 5

    Catao Market is recalling 775 master cases of Gaceniga Authentic Cuban Loaf Cake Classic because the colour FD&C Yellow #5 was not declared on the label.

    Product
    Gacen¿iga Authentic Cuban Loaf Cake Classic (Net Wt. 24 oz (680g)) packaged in wax paper, placed in clear bag and packed in cardboard carton. 12/ 24 oz per master case.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1138-2026·2026-01-28

    iM20 patient monitors recalled over potential cybersecurity issues flagged by FDA

    Edan Diagnostics is recalling 377 units of its iM20 Patient Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training. The low base variant includes smaller casters and lower base frame so that th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1142-2026·2026-01-28

    M3 vital signs monitors recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 13,934 units of its M3 Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-inv
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1153-2026·2026-01-28

    M3A vital signs monitors recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 12,201 units of its M3A Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1136-2026·2026-01-28

    Laboratory tube sorters recalled over a lift that may drop unexpectedly

    Sysmex America is recalling 44 TS-10/TS-10H Tube Sorters because the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement.

    Product
    TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1144-2026·2026-01-28

    iM3s series vital signs monitors recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 136 units of its Vital Signs Monitor models iM3s, iM3As, iM3Bs and iHM3s after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1134-2026·2026-01-28

    iM series patient monitors recalled over potential cybersecurity issues flagged by FDA

    Edan Diagnostics is recalling 14,550 units of its Patient Monitor models iM50, iM60, iM70 and iM80 after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System
    Category
    Medical Device
    Distribution
    51 states
  • ModerateFDA (Devices)·Z-1143-2026·2026-01-28

    iM3 vital signs monitors recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 11,987 units of its iM3 Vital Signs Monitor after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0458-2026·2026-01-28

    Cuban crackers recalled over three undeclared artificial colors

    Lily's Bakery Factory is recalling 890 boxes of Cuban Crackers Galletas Cubanas over undeclared FD&C Yellow #5, FD&C Yellow #6 and FD&C Red 40.

    Product
    Cuban Crackers Galletas Cubanas, Net Wt 8Oz (226g). Distributed by Best Floridian, LLC. UPC 5700300060
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1154-2026·2026-01-28

    iM8 series patient monitors recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 3,141 units of its Patient Monitor models iM8, iM8A and iM8B after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and cont
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1151-2026·2026-01-28

    MFM-CNS clinical data software recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 395 units of its Central Monitoring System models MFM-CNS and MFM-CNS Lite after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1146-2026·2026-01-28

    Elite V series patient monitors recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 342 units of its Patient Monitor models elite V5, elite V6 and elite V8 after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Als
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1140-2026·2026-01-28

    Fetal monitors recalled over potential cybersecurity issues flagged by FDA

    Edan Diagnostics is recalling 3,721 units of its Fetal Monitor models F2 and F3 after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1131-2026·2026-01-28

    Distal radius plates recalled over an incorrect thread orientation

    Tyber Medical is recalling 100 VOLT Wrist Treatment System distal radius plates because the supplier manufactured anatomical left plates with an incorrect thread orientation.

    Product
    Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1141-2026·2026-01-28

    Fetal and maternal monitors recalled over potential cybersecurity issues

    Edan Diagnostics is recalling 3,518 units of its Fetal & Maternal Monitor models F6, F9, F6 Express and F9 Express after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1148-2026·2026-01-28

    X series patient monitors recalled over potential cybersecurity issues flagged by FDA

    Edan Diagnostics is recalling 3,824 units of its Patient Monitor models X8, X10 and X12 after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: X8, X10, X12 Product Description: The X8 X10 X12 Patient Monitor (hereinafter called X series) can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1150-2026·2026-01-28

    Central monitoring systems recalled over potential cybersecurity issues flagged by FDA

    Edan Diagnostics is recalling 195 units of its MFM-CMS Central Monitoring System after an FDA letter raising potential cybersecurity issues with the firm's devices.

    Product
    Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CMS Product Description: MFM-CMS is a central monitoring system product, which can connect and manage information from EDAN medical devices. MFM-CMS offers central management for monitoring info
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1119-2026·2026-01-28

    Mini Cuban loaf cake with raisins recalled over undeclared FD&C Yellow 5

    Catao Market is recalling 260 master cases (3,120 loaf cakes) of Mini Gaceniga Authentic Cuban Loaf Cake Raisins because the colour FD&C Yellow #5 was not declared on the label.

    Product
    ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1118-2026·2026-01-28

    Plum Duo infusion pumps recalled over blocked piggyback flush programming

    ICU Medical is recalling the Plum Duo Infusion Pump because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.

    Product
    ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0409-2026·2026-01-28

    Mini classic Cuban loaf cake recalled over undeclared FD&C Yellow 5

    Catao Market is recalling 385 master cases of Mini Gaceniga Authentic Cuban Loaf Cake Classic because the colour FD&C Yellow #5 was not declared on the label.

    Product
    Gregory's Foods Bag Full of Cookies, White Chocolate Macadamia Nut, frozen cookie dough. Net Wt 2 lbs 8.5 oz (1148g). UPC 8 30825-00124 7. Keep Frozen. Gregory's Foods, Inc., 1301 Trapp Road, Eagan, MN 55121.
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Food)·H-0457-2026·2026-01-28

    Powered lift transfer devices recalled over potential fraying on support straps

    Community Products is recalling 1,096 units of the Rifton Low Base TRAM over potential fraying on the body support strap.

    Product
    MEAL SIMPLE RED LENTIL DAL SOUP NET WT. 16 OZ (1 LB) 454g UPC 1 97870 07333 0 MADE WITH PRIDE AND CARE FOR H-E-B-, SAN ANTONIO, TEXAS 78204
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1133-2026·2026-01-28

    Reusable hip trial components recalled over missing FDA premarket authorization

    MicroPort Orthopedics is recalling 91 units of the HIPTURN 36mm reusable femoral head trial because the product does not have FDA premarket authorization for US distribution.

    Product
    Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Food)·H-0416-2026·2026-01-28

    Cuban loaf cake with raisins recalled over undeclared FD&C Yellow 5

    Catao Market is recalling 520 master cases of Gaceniga Authentic Cuban Loaf Cake Raisins because the colour FD&C Yellow #5 was not declared on the label.

    Product
    White Castle Original Sliders, Net Wt. 6.35 oz. (180g), packaged as a 4-count carton, each containing 2-Two Packs. UPC 082988029693, packed 6 cartons per case.
    Category
    Food
    Distribution
    3 states
  • LowFDA (Devices)·Z-1130-2026·2026-01-28

    Surgical laser consoles recalled over a label missing the DANGER symbol

    Leaseir Technologies is recalling two MHR Xcell surgical laser systems because the console label on the affected devices is missing the "DANGER" symbol.

    Product
    Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leaseir MHR Xcell is a surgical laser instrument for use in general and plastic surgery and dermatology, intended for hair removal and treatm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·26V044000·2026-01-26

    Grand Design fifth wheel U-bolts may loosen and shift the axle

    Grand Design is recalling certain 2021-2024 Momentum and 2022-2024 Solitude fifth wheel trailers because the U-bolt may become loose, causing the axle to move out of position.

    Product
    GRAND DESIGN — GRAND DESIGN MOMENTUM, SOLITUDE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V046000·2026-01-26

    Kia vehicles recalled for instrument panel display software failure

    Kia is recalling multiple 2025–2026 models due to a software error that may cause the instrument panel display to fail, potentially hiding critical safety information like the speedometer and warning lights.

    Product
    KIA — KIA SPORTAGE PHEV, SORENTO PHEV, SPORTAGE HYBRID, SPORTAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V045000·2026-01-26

    Keystone Recalls 2026 Coleman Travel Trailers Due to Bed Bracket Defect

    Keystone is recalling 2026 Coleman travel trailers because bed brackets may not be secured to a stud, causing the bed to fall unexpectedly and increasing injury risk.

    Product
    KEYSTONE — KEYSTONE COLEMAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·26V047000·2026-01-26

    Hyundai vehicles instrument panel display software error recall

    Hyundai is recalling certain 2025–2026 Tucson Hybrid, Tucson PHEV, and other 2026 models due to a software error that may cause the instrument panel display to fail, potentially hiding critical safety information like the speedometer and warning lights.

    Product
    HYUNDAI — HYUNDAI IONIQ 5, KONA, PALISADE, PALISADE HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide

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