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.

12751–12775 of 22165

  • HighFDA (Devices)·Z-0965-2024·2024-02-07

    Medline Blood Culture Collection Kit Recalled for Expired Bactec Component

    Medline Industries recalls specific lots of blood culture collection kits because the Bactec component expiration date was not documented on the kit insert. Users who fail to check the component's expiration date inside the kit risk using an expired diagnostic component.

    Product
    MEDLINE BLOOD CULTURE COLLECTION KIT, Reorder Number DYNDH1714A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·23V486000·2024-02-07

    Motorhomes: Overheating HVAC Wiring Could Cause Fires in Entegra, Jayco Models

    Certain 2020-2021 Entegra and Jayco motorhomes are recalled because inadequate HVAC blower motor circuit wiring can overheat, increasing fire risk. The remedy involves relocating and replacing the fuse and wiring harness.

    Product
    ENTEGRA — 2020 ENTEGRA QWEST
    Category
    Vehicle
    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-0925-2024·2024-02-07

    PS Lipped Tibial Insert Assy Duracon Knee Implant Oxidation Risk

    Howmedica Osteonics is recalling PS Lipped Tibial Insert knee replacement components manufactured with aged UHMWPE material that may develop oxidation, potentially affecting device properties and performance.

    Product
    PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-416
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0932-2024·2024-02-07

    Volar Bearing Plate wrist fixation systems recalled for bearing dislodgement

    TriMed Inc. recalls Volar Bearing Plate wrist fixation systems because bearings may dislodge from distal peg holes during implantation, potentially compromising fracture fixation. Approximately 270 units distributed in five states.

    Product
    Volar Bearing Plate. REF: VBEAL-3-7N, VBEAL-5-7N, VBEAL-3-7S, VBEAL-5-7S, VBEAL-7-7S, VBEAL-3-7W, VBEAL-5-7W, VBEAR-3-7N, VBEAR-5-7-N, VBEAR-3-7S, VBEAR-5-7S, VBEAR-7-7S, VBEAR-3-7W, VBEAR-5-7W. Intended to be used as an aid to the treatment of certain types of fractures,
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0877-2024·2024-02-07

    Knee Replacement Implant Insert Recalled Due to Material Degradation Risk

    Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee replacement components due to potential oxidation of raw material. Material degradation could affect implant durability.

    Product
    SCORPIO TS TIB INSERT-Intended for knee replacement Part Number:72-4-7512
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0971-2024·2024-02-07

    Atlan Anesthesia Machine Backup Battery May Fail Unexpectedly During Operation

    Draegerwerk has recalled Atlan A350 and A350 XL anesthesia machines because the internal backup battery may fail unexpectedly, potentially causing device shutdown during operation. No injuries or device failures have been reported.

    Product
    Atlan, Gas Machine for Anesthesia or Analgesia, Catalog numbers 8621500 (Atlan A350) and 8621600 (Atlan A350 XL)
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0935-2024·2024-02-07

    Olympus EZDilate Fixed Wire Balloon Device Recalled for Inflation and Deflation Failures

    Olympus recalls 1,008 EZDilate Fixed Wire Balloon devices nationwide due to malfunction during use. Reported failures include inflation and deflation problems, bursting, leaking, and foreign body events in patients.

    Product
    EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years). Model: BD-400P-1380
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0799-2024·2024-02-07

    Benny T's Vesta Hot Sauce Recalled for Undeclared Wheat Allergen

    Benny T's Vesta Dry Hot Sauce is recalled because wheat is not declared in the ingredient statement. The missing wheat label poses a risk to consumers with wheat allergies.

    Product
    the original BENNY T'S VESTA DRY HOT SAUCE REAPER NET WT. 1.5OZ INGREDIENTS: Fresh Chilies, Onions, Breadcrumbs (enriched flour, water, sugar, yeast, salt, non-hydrogenated vegetable shortening), Olive Oil, Salt, Natural Preservatives. UPC 7 94571 99490 4 (Carolina Reaper)
    Category
    Food
    Distribution
    24 states
  • HighFDA (Devices)·Z-0956-2024·2024-02-07

    Philips MRI coil seal adhesive may fail, creating sharp edges and injury risk

    A Philips MRI coil component's adhesive may fail and create sharp edges that could injure patients during scanning. The defect affects 286 units worldwide.

    Product
    SmartPath to dStream for XR and 3.0T. Model (REF) Numbers 781270, 782113, 782129.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0886-2024·2024-02-07

    Knee Replacement Component Recalled Due to Raw Material Oxidation Risk

    Howmedica Osteonics Corp. is recalling a SCORPIO TOTAL KNEE prosthesis component because UHMWPE raw material over 5 years old may have elevated oxidation levels affecting material properties and implant performance. Consumers with this implant should contact their physician for guidance.

    Product
    SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0832-2024·2024-02-07

    Ophthalmic procedural kits recalled due to inadequate sterilization validation

    American Contract Systems is recalling 940 ophthalmic surgical kits nationwide due to undocumented components that may lack functionality, drug efficacy, or contain elevated sterilization residuals.

    Product
    Custom procedural convenience kits and trays, Ophthalmic use, labeled as: a) EYE PACK, kit number LVEY27; b) Laminectomy, kit number UIOL34AG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0918-2024·2024-02-07

    Knee replacement implants recalled for potential material degradation

    Howmedica Osteonics Corp. is recalling DURATION Plastic Patella knee replacement implants due to potential oxidation in UHMWPE raw material over 5 years old, which may affect implant durability.

    Product
    DURATION PLASTIC PATELLA-DURACON Intended for knee replacement Product Number: 6642-2-200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0796-2024·2024-02-07

    Dried plums recalled due to undeclared sulfites

    Win Luck Trading Inc recalled Tasty Snacks Plum Queen Dried Plums (7 ounce cans, code 12122023) because the product contains undeclared sulfites, a food allergen.

    Product
    Tasty Snacks Plum Queen Dried Plums Net Weight 200G (7OZ) Packaged in cans. 30 cans per case.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0916-2024·2024-02-07

    Knee replacement tibial insert recalled due to material oxidation risk

    Howmedica Osteonics Corp. is recalling DURATION knee replacement tibial inserts manufactured with raw materials over 5 years old that have developed oxidation. Oxidation can degrade the material's structural properties, affecting implant performance.

    Product
    DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-709
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0823-2024·2024-02-07

    Urological procedural kits recalled due to sterilization defects

    American Contract Systems recalled 1,031 urological procedure kits nationwide due to sterilization process defects. Components may have damaged functionality, reduced drug efficacy, or elevated sterilization residuals.

    Product
    Custom procedural convenience kits and trays, urological, labeled as: a) UROLOGY DAVINCI PACK, kit number HGUR87G; b) CYSTO PACK, kit number LVCY20; c) URO ROBOTIC PACK, kit number LVUR44;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0811-2024·2024-02-07

    Mint Dark Chocolate bars recalled for undeclared soy allergen

    Font Group of America is recalling Mint Dark Chocolate bars (ToYou Snacks Brand) due to undeclared soy allergen. Consumers with soy allergies should not consume the product.

    Product
    Mint 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-0828-2024·2024-02-07

    Obstetrical and Gynecological Surgical Kits Recalled for Sterilization Assessment Defects

    American Contract Systems is recalling 1,020 obstetrical and gynecological surgical kits because components were sterilized without documented assessment of their suitability to the process, potentially causing loss of functionality or drug efficacy.

    Product
    Custom procedural convenience kits and trays, Obstetrical & Gynecological use, labeled as: a) LOWER PELVIC PACK, kit number AGLP52L; b) OB/GYN DAVINCI PACK A RG BASIN, kit number HGOB98G; c) DAVINCI GYN PACK, kit number HHDV17; d) KIT, GYNE ROBOTIC, kit number MMGR44D;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2024·2024-02-07

    Knee replacement patella component recalled due to material oxidation risk

    Howmedica Osteonics Corp. is recalling SCORPIO RECESSED PATELLA knee replacement components manufactured from UHMWPE raw material over 5 years of age, which may develop elevated oxidation affecting material properties.

    Product
    SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0911-2024·2024-02-07

    Knee replacement implant recalled due to material oxidation risk

    Howmedica is recalling knee replacement implants manufactured with UHMWPE material over 5 years old due to potential oxidation that could affect material properties.

    Product
    RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-831
    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-0912-2024·2024-02-07

    Knee Replacement Implant Recalled Due to Potential Material Oxidation Risk

    Howmedica Osteonics Corp. is recalling certain knee replacement implants made with UHMWPE material over 5 years old that may have oxidized, potentially affecting implant performance.

    Product
    RGT.LARGE-PCA MOD.REV.- DUR.REV.INSERT Intended for knee replacement Product Number: 6637-0-928
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0948-2024·2024-02-07

    Philips Achieva 3.0T MRI Coil Seal Adhesive May Fail, Risking Patient Injury

    The Quadrature Body Coil seal adhesive in Philips Achieva 3.0T MRI scanners may fail, creating sharp edges that can injure patients. All units with model numbers 781277, 781177, 781278, 781344, and 781345 are affected.

    Product
    Achieva 3.0T. Model. (REF) Numbers 781277, 781177, 781278, 781344, 781345.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0967-2024·2024-02-07

    Medline Blood Culture Kits Recalled: Expired Component Not Disclosed on Insert

    Medline Industries is recalling certain blood culture kits due to a Bactec component with an expiration date not reflected on the kit insert. Users may unknowingly use an expired component if they do not check the Bactec itself.

    Product
    MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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