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.

8201–8225 of 52968

  • HighFDA (Devices)·Z-2265-2024·2024-07-10

    Abbott Liberta RC Pulse Generator Unexpectedly Shuts Down Periodically

    Abbott Liberta RC implantable pulse generators used for deep brain stimulation may unexpectedly turn off approximately every 50 days after activation, resulting in loss of therapy. Approximately 302 units have been recalled nationwide.

    Product
    Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0579-2024·2024-07-10

    Methylphenidate Hydrochloride Extended-Release Tablets Recalled for Failed Dissolution

    Trigen Laboratories recalls Methylphenidate Hydrochloride Extended-Release Tablets (36mg) because a batch failed dissolution specifications. Approximately 10,448 bottles were distributed nationwide.

    Product
    METHYLPHENIDATE HYDROCHLORIDE — METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1462-2024·2024-07-10

    Breadman Brioche Products Recalled for Undeclared Yellow No. 5

    Breadbox Co. is recalling Breadman Brioche products (Toast, Buns, Sliders, Hot Dog) distributed in Southern California due to undeclared Yellow No. 5, which may affect consumers sensitive to this color additive.

    Product
    Breadman Brioche products in plastic bags: Brioche Toast, 2 lb. (1 loaf/bag), Brioche Buns, 40oz (10 buns/bag), Brioche Sliders, 50oz (25 sliders/bag), Brioche Hot Dog, 40oz (10 buns/bag)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2256-2024·2024-07-10

    BD Pyxis automated dispensing cabinets with noncertified power strips

    BD Pyxis automated dispensing cabinets were shipped with socket-outlet power strips that lack IEC electrical certification, potentially exposing users to leakage currents and electric shock.

    Product
    BD Pyxis, Name/REF: BD PYXIS MB TOWER MAIN/ 169-153, BD PYXIS MB TOWER MAIN CR/ 169-154, BD PYXIS MB TOWER MAIN W/MP/ 169-157, BD PYXIS MB TWR MN 1FM-10HH-1FH MP/ 169-143, BD PYXIS MB TWR MN 2FH-1FM-4HH-2FM MP/ 169-145, BD PYXIS MB TWR MN 2FM-8HH-1FH MP/ 169-144, BD PYXIS MB TWR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·PHA-07102024-01·2024-07-10

    USDA Issues Public Health Alert for Illegally Imported Philippine Meat and Poultry

    USDA FSIS issued a public health alert for ready-to-eat meat and poultry products illegally imported from the Philippines. Consumers and retailers in nine states are urged not to consume or sell these items.

    Product
    FSIS Issues Public Health Alert for Ineligible Meat and Poultry Products Illegally Imported from the Philippines
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-2238-2024·2024-07-10

    AMT Initial Placement Dilator Set Recalled Due to Incorrect Guidewire Labeling

    Applied Medical Technology is recalling 74 units of the AMT Initial Placement Dilator Set (Model IP-DIL) due to incorrect guidewire labeling. The labeling error could result in improper guidewire selection during gastrostomy placement procedures.

    Product
    AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2267-2024·2024-07-10

    Prostate Treatment Balloons Recalled Due to Fill Volume Mislabeling

    Angiodynamics is recalling IsoLoc Prostate Immobilization Balloons (ISO-100, Lot 5402) for mislabeling. Devices have 100cc fill volume but are labeled as ISO-60 (60cc).

    Product
    IsoLoc Prostate Immobilization Treatment Balloon Device Kit, Catalog/UPN: ISO-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2234-2024·2024-07-10

    Fathom Pedicle Retractor Blades Recalled for Manufacturing Defect

    SeaSpine Orthopedics recalls Fathom Pedicle-Based Retractor C/C Blades due to manufacturing defects that could cause bone fracture or damage during surgery. 21 units were distributed nationwide.

    Product
    Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2261-2024·2024-07-10

    Stryker Corporation Recalls Expired Sterile Surgical Cannula Devices

    Stryker Corporation has recalled expired sterile cannula devices distributed nationwide. The devices were past their expiration date, potentially compromising sterility and device safety.

    Product
    This product is a single use sterile device that is used to direct the lesion to the targeted site. Each cannula contains a stylet that is removed once the cannula is placed. The electrode is then inserted into the cannula. Catalog Number: 0406-630-225
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1471-2024·2024-07-10

    Ice Cream Recall: Foreign Rubber Found in Cookie Dough Product

    Casper's Ice Cream recalls Red Button Vintage Creamery Cookie Dough Ice Cream due to rubber pieces found in two tubs. The product was distributed across eight western states.

    Product
    Red Button Vintage Creamery Cookie Dough Ice Cream, Net weight 1.75 qt (1.66 L).
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-2242-2024·2024-07-10

    ARTIS Angiography Systems Recalled for Potential Radiation Overdose

    Siemens ARTIS icono angiography systems with specific detector configurations may deliver higher radiation doses than intended in rare cases. The issue occurs during the first X-ray exposure after patient registration.

    Product
    ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2246-2024·2024-07-10

    Portable X-Ray Cart Positioning Arm Bolt May Come Loose and Fall

    First Source Inc is recalling the First Source Vision M portable X-ray cart because the bolt securing the positioning arm to the gas spring may come loose and fall onto a patient.

    Product
    First Source Vision M. Portable cart and platform that supports an X-ray system and laptop computer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0570-2024·2024-07-10

    Budesonide USP drug ingredient recalled for glass contamination

    Medisca Inc. is recalling 113 bottles of Budesonide, USP (Micronized) 500 mg due to glass particulate matter contamination caused by manufacturing deviations. The product was distributed nationwide in the USA and Canada.

    Product
    Budesonide, USP (Micronized), 500 mg, White to off-white odorless, crystalline powder, Medisca Inc., Plattsburgh, NY, 12901, USA, NDC: 38779-3097-00.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0574-2024·2024-07-10

    FDA recalls Dream Cream topical product due to manufacturing quality violations

    Little Moon Essentials voluntarily recalls Dream Cream due to manufacturing quality control violations. No illnesses reported.

    Product
    Little Moon Essentials, Dream Cream (Camphor 0.45%, Menthol 5%), Packaged as a) 2OZ (57G) glass jar, UPC Code 6 73673 88214 5, NDC 70722-232-02; b) 4OZ (113G) glass jar, UPC Code 6 73673 88804 8, NDC 70722-232-04; Little Moon Essentials LLC Dania Beach, Fl 33004
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2266-2024·2024-07-10

    VITROS Chemistry FS Diluent Pack 3 Recalled for Negatively Biased Test Results

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry FS Diluent Pack 3, Lot 01-1645, because it may produce negatively biased results when used with CRP slides, potentially affecting patient diagnosis and care.

    Product
    VITROS Chemistry Products FS Diluent Pack 3, Model/Catalog Number: 6801754. Product Description: VITROS Chemistry Products FS Diluent Pack 3 comes with 3 packs per sales unit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0583-2024·2024-07-10

    Allopurinol tablets recalled due to presence of foreign substance

    Dr. Reddy's Laboratories is recalling Allopurinol 300mg tablets due to the presence of a foreign substance. Approximately 20,520 units were distributed in Illinois, Mississippi, and Ohio.

    Product
    ALLOPURINOL — ALLOPURINOL (ALLOPURINOL)
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Devices)·Z-2257-2024·2024-07-10

    Nalu Neurostimulation Kits Recalled for Manufacturing Defect and Device Failure

    Nalu Medical recalls 13 neurostimulation and peripheral nerve stimulation kits due to a manufacturing defect that may prevent the implantable pulse generator from functioning, stopping pain signal inhibition.

    Product
    Neurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1456-2024·2024-07-10

    Lactose Powder Recalled Due to Potential Salmonella Contamination

    Grande Ingredients has recalled lactose and lactose powder products due to potential Salmonella contamination. No illnesses have been reported.

    Product
    Drug Emporium Yogurt Flavored Pretzels, 8oz (227g) , GNS Foods, Arlington, TX 76011
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·24V524000·2024-07-09

    Volvo Bus 9700 Recall for Steering Gear Link Rod Nut Tightening

    Volvo Bus is recalling 2024 9700 vehicles because improperly tightened nuts on the steering gear link rod may loosen, potentially causing loss of steering control.

    Product
    VOLVO BUS — VOLVO BUS 9700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V523000·2024-07-09

    Prevost buses recalled for defective wheelchair lift bridging device

    Prevost recalls certain 2005-2024 buses with wheelchair lifts due to a potentially steep bridging device that can cause wheelchair instability. Affected owners should contact Prevost for a free replacement.

    Product
    PREVOST — PREVOST X3-45, H3-45 VIP, X3-45 COMMUTER, H3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V516000·2024-07-08

    2021-2022 Jeep Cherokee Curtain Airbag Connector May Fail to Deploy

    Chrysler is recalling 2021-2022 Jeep Cherokee vehicles with improperly secured right-side curtain airbag connectors that may prevent deployment, increasing injury risk in a crash.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V519000·2024-07-08

    Nova Bus LFS windshield wiper blade alignment defect recall

    Nova Bus is recalling certain 2022-2023 LFS buses due to incorrectly aligned windshield wiper arms that can cause wiper blades to collide. Damaged blades reduce visibility and increase crash risk.

    Product
    NOVA BUS — NOVA BUS LFS
    Category
    Vehicle
    Distribution
    Distributed nationwide