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.

10826–10850 of 53043

  • HighNHTSA·23V831000·2023-12-07

    Pilotcar Recalls 2021-2023 Models for Missing Rearview Camera Systems

    Pilotcar is recalling 265 vehicles from 2021-2023 because the rearview camera and monitor were not installed, reducing rear visibility and increasing crash risk.

    Product
    PILOTCAR — PILOTCAR PC-6, PC-4, PC-2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23T010000·2023-12-07

    Sumitomo Recalls Falken Tires Due to Sidewall Puncture Risk

    Sumitomo is recalling specific Falken Wildpeak tires because a manufacturing error may cause sidewall punctures and air leaks, increasing crash risk.

    Product
    TIRES:SIDEWALL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·24047·2023-12-07

    Windsor Queen Xtrabed Mobile Murphy Beds Recalled for Injury and Tip-Over Hazards

    SourceOne Ventures recalls Windsor Queen Xtrabed Mobile Murphy Beds due to risks of cabinet breakage and tip-over. About 12,000 units sold at Wayfair between November 2016 and April 2023 are affected.

    Product
    Windsor Queen Xtrabed Mobile Murphy Beds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0124-2024·2023-12-06

    Prescription Naproxen 250mg tablets recalled for labeling mix-up with indomethacin

    Glenmark Pharmaceuticals is recalling Naproxen Sodium 250mg tablets nationwide due to a labeling mix-up where Indomethacin bottles may be labeled as Naproxen. Patients could receive the wrong medication.

    Product
    NAPROXEN SODIUM — NAPROXEN SODIUM (NAPROXEN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0479-2024·2023-12-06

    Sprite 12-ounce cans recalled due to potential foreign material

    United Packers, LLC is recalling Sprite in 12-ounce aluminum cans distributed in Alabama, Florida, and Mississippi due to potential foreign material contamination.

    Product
    Sprite packaged in 12oz aluminum cans - 12 pack fridge pack
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0128-2024·2023-12-06

    Paroxetine Tablets Recalled Due to Out-of-Specification Impurity Levels

    Paroxetine tablets are being recalled for failing specification tests due to higher-than-acceptable levels of a degradation impurity. Approximately 1,941 bottles distributed nationwide are affected.

    Product
    PAROXETINE — PAROXETINE (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0405-2024·2023-12-06

    Breas Medical Ventilator Mouthpiece Recall: Unintended Slits May Reduce Ventilation

    Breas Medical is recalling 215 mouthpiece units due to manufacturing defects with unintended slits that may result in insufficient ventilation in mechanical ventilation patients.

    Product
    with Notch 22M/15F sold as part of Breas Medical MPV circuit 2 pc Kits: 006093, 006653, an accessory to ventilator device, Vivo 45LS. intended for partial insertion into a patient's mouth (in between the lips) to facilitate access to the respiratory system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0121-2024·2023-12-06

    Paroxetine Hydrochloride 30 mg Tablets Recalled for Impurity Specification Failure

    Apotex Corp. is recalling nationwide 25,776 units of Paroxetine Hydrochloride 30 mg tablets due to out-of-specification impurities. Affected lot numbers RV8686, RX0119, and RV2254 expire 08/2024.

    Product
    PAROXETINE — PAROXETINE (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0122-2024·2023-12-06

    Paroxetine Hydrochloride Tablets Recalled for Out-of-Specification Impurity

    Apotex Corp. is recalling Paroxetine Hydrochloride 40 mg tablets nationwide due to failed quality specifications. Testing found out-of-specification impurity levels in affected lot numbers.

    Product
    PAROXETINE — PAROXETINE (PAROXETINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0478-2024·2023-12-06

    Fanta Orange in 12-pack cans recalled due to potential foreign material

    United Packers is recalling Fanta Orange in 12-pack aluminum cans due to potential foreign material. The affected product (Lot No. JUL2924MBD3) was distributed to Alabama, Florida, and Mississippi.

    Product
    Fanta Orange packaged in 12oz aluminum cans - 12 pack fridge pack
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·23V818000·2023-12-06

    KME Recalls 2020 Fire Trucks Due to Electrical Fire Risk

    Kovatch Mobile Equipment is recalling 2020 Severe Service, Predator, and Spartan MetroStar trucks because a firmware defect may cause electrical fires.

    Product
    KME — KME, SPARTAN FIRE SEVERE SERVICE, PREDATOR, METROSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0466-2024·2023-12-06

    California Baking Company Telera Bread Recalled for Undeclared Milk Allergen

    California Bread Co. is recalling Telera Bread products due to undeclared milk allergen. The recall involves 8,959 packages distributed in California.

    Product
    California Baking Company Telera Bread (La Torta Bread), 6 pack (26 oz) and 12 pack (58 oz), plastic bags
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0421-2024·2023-12-06

    Medtronic Insertable Cardiac Monitor May Fail to Record Heart Rhythms

    Medtronic recalled 64,739 ICM LNQ22 LINQ II insertable cardiac monitors due to potential amplified noise or signal reduction that may interfere with heart rhythm recordings.

    Product
    ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0400-2024·2023-12-06

    BD Insyte Autoguard IV Catheter Needles May Fail to Retract Properly

    BD Insyte Autoguard BC IV catheters may have needles that fail to retract properly, potentially causing contaminated needlestick injuries, blood leakage, and repeated insertion attempts.

    Product
    BD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in, REF: 382533
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0401-2024·2023-12-06

    SENTIERO Hearing Examination Device Recalled for Technical Distortions

    PATH recalls SENTIERO hearing examination devices for excessive technical distortions. Affected units are distributed in FL, MO, OH, and WI.

    Product
    SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098
    Category
    Medical Device
    Distribution
    4 states
  • HighNHTSA·23V820000·2023-12-06

    Ducati Recalls XDiavel Motorcycles Due to Passenger Backrest Defect

    Ducati is recalling 2016-2023 XDiavel S and STD motorcycles because the passenger backrest may break, increasing the risk of the passenger falling off.

    Product
    DUCATI — DUCATI XDIAVEL S, XDIAVEL STD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0407-2024·2023-12-06

    Abbott Alinity m HCV Kit Recalled for False Positive Results

    Abbott is recalling specific lots of the Alinity m HCV AMP Kit due to reports of false positive results and reactive negative controls. The kit detects hepatitis C virus in blood samples.

    Product
    Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0416-2024·2023-12-06

    Improperly Repaired Gastrointestinal Videoscope May Expose Patients to Contamination

    Aizu Olympus gastrointestinal videoscopes (GIF-H190) may have defective repairs that prevent proper sterilization, risking patient exposure to contaminated material. Affected units were distributed to medical facilities in six states.

    Product
    GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Drugs)·D-0123-2024·2023-12-06

    Prescription Drug Indomethacin Recalled Due to Label Mix-Up

    Glenmark Pharmaceuticals is recalling 37,200 bottles of Indomethacin 25mg capsules distributed nationwide because the bottles may be labeled as Naproxen instead. This labeling error could cause medication confusion.

    Product
    INDOMETHACIN — INDOMETHACIN (INDOMETHACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0468-2024·2023-12-06

    Bonta Stracciatella gelato recalled due to undeclared soy lecithin

    Bonta Natural Artisan Gelato Stracciatella is being recalled due to undeclared soy lecithin. Soy is a major allergen; consumers with soy allergies should not consume this product.

    Product
    Bonta Natural Artisan Gelato Stracciatella is frozen dessert, packaged in blue cardboard pint cups (UPC 58745 00309) and in green cardboard half-gallon tubs (UPC 58745 00306). The 1 Pint label is read in parts: "Stracciatella Sweet Cream Freckled with crunchy 70% Dark…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0415-2024·2023-12-06

    Olympus colonoscope repair defect may impair imaging and suction function

    Aizu Olympus is recalling 24 colonoscopes with defective repairs to the light guide connector. The defect may prevent proper imaging, reduce suction, and impair device cleaning, potentially exposing patients to contamination.

    Product
    CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0417-2024·2023-12-06

    Gastrointestinal Videoscope Recall Due to Improper Repair and Infection Risk

    Aizu Olympus recalls 24 gastrointestinal videoscopes with improperly repaired light guide connectors. The defect may cause loss of image and suction, preventing proper device reprocessing and risking patient infection.

    Product
    GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
    Category
    Medical Device
    Distribution
    6 states