The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

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.

12676–12700 of 22165

  • HighFDA (Devices)·Z-0938-2024·2024-02-07

    EZDilate Fixed Wire Balloon Medical Device Recalled Due to Device Failures

    Olympus is recalling 8,294 EZDilate Fixed Wire Balloon devices due to reports of device failures including bursting, leaking, and foreign body retention in patients undergoing esophageal dilation.

    Product
    EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-2080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0880-2024·2024-02-07

    Knee Replacement Implant Recalled for Potential Material Degradation Risk

    Howmedica Osteonics Corp. is recalling SCORPIO TS TIB knee replacement implants manufactured with aged raw material that may develop oxidation, potentially affecting performance.

    Product
    SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0833-2024·2024-02-07

    Orthopedic surgical kits recalled for unassessed external component sterilization

    American Contract Systems recalls 5,524 orthopedic surgical kits due to unassessed sterilization of external components that may lose functionality, drug efficacy, or have excess sterilization chemical residue.

    Product
    Custom procedural convenience kits and trays, Othopedic use, labeled as: a) HIP FRACTURE, kit number AHHF15C; b) HIP FRACTURE, kit number AHHF15D; c) Hand Pack, kit number BBHP10E; d) Lower Extremity, kit number BBLE40B; e) Custom Podiatry, kit number BOCP70J; f) ROB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0824-2024·2024-02-07

    Custom Surgical Convenience Kits May Lack Proper Sterilization Validation

    American Contract Systems, Inc. recalls surgical convenience kits whose added components may lack proper sterilization validation, potentially resulting in loss of functionality or retained sterilant residue.

    Product
    Custom procedural convenience kits and trays, general & plastic surgery, labeled as: a) Breast Plastics Pack, kit number BBPL20D; b) MINOR PLASTIC, kit number WPMP16H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0806-2024·2024-02-07

    Aldi Choceur Burnt Caramel Chocolate Bars Recalled for Undeclared Coconut

    Astor Chocolate Corp. has recalled Aldi Choceur Burnt Caramel Chocolate Bars due to undeclared coconut, a common allergen. The voluntary recall involves 1,092 units distributed to a distribution center in Florida.

    Product
    Aldi Choceur Burnt Caramel Chocolate Bars, Net Wt. 1.75oz. UPC 4099100202809
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0903-2024·2024-02-07

    Howmedica Osteonics Trident Knee Insert Recalled for Oxidation Risk

    Howmedica Osteonics Trident knee replacement inserts manufactured with raw material over 5 years old may have elevated oxidation levels affecting material properties. This FDA Class II recall applies to Lot Number 29518001.

    Product
    HOWMEDICA OSTEONICS TRIDENT 0 deg POLY INSERT Intended for knee replacement Part Number: 620-00-32J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0905-2024·2024-02-07

    Knee replacement inserts recalled due to material oxidation risk

    P7 knee replacement inserts may contain UHMWPE material over 5 years old that has developed oxidation, potentially degrading the material's properties. Patients should consult their healthcare provider.

    Product
    P7 32MM 1O DEGREE +4MM INSERT Intended for knee replacement Part Number: 6302-6-307
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0873-2024·2024-02-07

    Series II Tibial Bear Insert Recalled for Potential Material Degradation

    Howmedica Osteonics Corp. is recalling the Series II Tibial Bear Insert for knee replacement because UHMWPE material over 5 years old may develop elevated oxidation that can affect the component's material properties.

    Product
    SERIES II TIBIAL BEAR INSERT-Intended for knee replacement Part Number: 3052-0515
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0895-2024·2024-02-07

    FDA Recalls SCORPIO U-DOME Knee Implants for Potential Material Oxidation

    Howmedica is recalling SCORPIO U-DOME PATELLA knee replacement implants manufactured with UHMWPE material over 5 years old due to potential elevated oxidation levels that could affect material properties.

    Product
    SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3508
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0955-2024·2024-02-07

    Philips MRI Coil Seal Adhesive May Fail and Create Sharp Patient Contact Surfaces

    Philips has recalled certain SmartPath to dStream MRI coil components because the seal adhesive may fail, creating sharp edges that could contact patients during scanning and cause skin and tissue injuries.

    Product
    SmartPath to dStream for 1.5T. Model (REF) Numbers 781260, 782112.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0913-2024·2024-02-07

    Knee Replacement Device Recalled Due to Potential Material Oxidation

    Howmedica Osteonics Corp. is recalling certain knee replacement devices (product number 6637-0-931, lot 57403601) because raw material used in manufacturing may be over 5 years old, potentially causing elevated oxidation that affects device durability.

    Product
    RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-931
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0897-2024·2024-02-07

    Knee replacement component recalled due to potential material oxidation

    Howmedica Osteonics recalls SCORPIO U-DOME PATELLA knee components. Older UHMWPE raw material may have elevated oxidation, potentially affecting material properties.

    Product
    SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0844-2024·2024-02-07

    Surgilon Braided Nylon Sutures Recalled for Excessive Gamma Sterilization

    Covidien LP recalls specific lots of Surgilon Braided Nylon sutures sterilized with excessive gamma radiation, which may weaken the sutures and cause wound complications.

    Product
    Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0947-2024·2024-02-07

    Philips Achieva 1.5T MRI system recalled for defective coil seal

    Philips is recalling the Achieva 1.5T Initial MRI system due to a defective Quadrature Body Coil seal. The adhesive may fail and create sharp edges that could cut or abrade patients during scanning.

    Product
    Achieva 1.5T Initial system. Model (REF) Numbers 781178.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0822-2024·2024-02-07

    Custom Surgical Procedure Kits Recalled for Improper Sterilization Assessment

    American Contract Systems is recalling 3,196 custom surgical procedure kits because sterilized components lacked documented suitability assessment. The components may have lost functionality or accumulated excessive sterilization residuals.

    Product
    Custom procedural convenience kits and trays, gastroenterological & urological, labeled as: a) LAP KIDNEY MODULE, kit number AGKD50L; b) ROBOTIC PROSTATE PACK - 264852, kit number ANPR34S; c) LAP CHOLE - 213388, kit number BFLC02AD; d) GENERAL LAPAROSCOPY PACK, kit numbe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0813-2024·2024-02-07

    Salted Caramel Dark Chocolate Bars Recalled for Undeclared Soy Allergen

    Font Group of America Corp. is recalling Salted Caramel Dark Chocolate bars due to undeclared soy allergen. The product may pose a risk to consumers with soy allergies.

    Product
    Salted Caramel Dark Chocolate bar, ToYou Snacks Brand, 1.41 Oz/ 40 g, packaged in kraft laminated paper, 14 bars in 1 box.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0910-2024·2024-02-07

    Knee Replacement Implant Components Recalled for Material Degradation Risk

    Howmedica Osteonics Corp. is recalling specific lots of knee replacement implant components manufactured with aged raw material. The UHMWPE material may experience oxidation that could affect its structural properties.

    Product
    LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0972-2024·2024-02-07

    NovoTHOR Whole Body Light Pod Gen 3.0 Canopy Strut Ball Stud May Fail

    A ball stud on the gas strut may fail on NovoTHOR Whole Body Light Pod units, potentially causing injury if the canopy malfunctions while someone is using the device.

    Product
    NovoTHOR Whole Body Light Pod, Gen 3.0 (1) Product Code S2188 - Reg (2) Product Code S2189 - Reg PRX (3) Product Code S2190 - XL
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0909-2024·2024-02-07

    Knee replacement implant recall due to material oxidation risk

    Howmedica Osteonics is recalling knee replacement implants manufactured with aged UHMWPE raw material that may have elevated oxidation levels, which could degrade the material's mechanical properties.

    Product
    LEFT X-LARGE-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-328
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0898-2024·2024-02-07

    Knee Replacement Implant Component Recalled Due to Material Oxidation Risk

    The FDA is recalling SCORPIO U-DOME PATELLA knee replacement components because manufacturing used raw material over 5 years old that may have elevated oxidation levels affecting the implant's material properties.

    Product
    SCORPIO U-DOME PATELLA -Intended for knee replacement Part Number: 73-3910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0927-2024·2024-02-07

    Cryo Module Tank Hose Assemblies Recalled for Material and Design Defects

    AtriCure recalls certain tank hose assemblies for Cryo Module equipment due to manufacturing defects. The units have incorrect inner tube material and missing required perforations on the outer sheathing.

    Product
    Cryo Module Accessories Domestic CMA-OUS, Product Catalog Number A001053
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0275-2024·2024-02-07

    FDA Recalls Budesonide Extended-Release Tablets for Failed Dissolution

    FDA has recalled approximately 10,672 bottles of Budesonide Extended-Release Tablets 9mg manufactured by Teva Pharmaceuticals due to failed dissolution specifications.

    Product
    BUDESONIDE — BUDESONIDE (BUDESONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0810-2024·2024-02-07

    Notoginseng Gout Granule Recalled for Undeclared Diclofenac and Dexamethasone

    8th Ave Pharmacy recalls Notoginseng Formula Special Gout Granule because the product contains undeclared pharmaceutical ingredients: Diclofenac and Dexamethasone Acetate. Consumers should not use this product.

    Product
    Notoginseng Formula Special Gout Granule; 100% Natural; 8 G x 10 PACKS; CITI TRADE INT'L LIMITED; ADDRESS: 3/FINTERNATIONAL PLAZA 20 SHEUNG YUET RD, KOWLOON BAY, KOWLOON; "Nourish and helps the kidney with detoxification. Effectively dissolves uric acid crystals in joints. Has a
    Category
    Food
    Distribution
    25 states
  • HighFDA (Devices)·Z-0879-2024·2024-02-07

    Knee Replacement Insert Recalled Due to Potential Material Oxidation

    Howmedica Osteonics recalls SCORPIO TS TIB INSERT knee replacement components manufactured with UHMWPE raw material over 5 years old, which may experience elevated oxidation affecting material properties. No injuries or illnesses have been reported.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0946-2024·2024-02-07

    Achieva 1.5T MRI Coil Seal Adhesive May Fail Creating Sharp Edges

    Philips Achieva 1.5T MRI scanner components may experience coil seal adhesive failure, creating sharp edges that could injure patients. Affected devices have been distributed worldwide.

    Product
    Achieva 1.5T Conversion. Model (REF) Numbers 781346, 781283.
    Category
    Medical Device
    Distribution
    Distributed nationwide