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.

11626–11650 of 53044

  • HighFDA (Devices)·Z-2625-2023·2023-09-27

    Philips Tempus Pro Patient Monitor Software Error Impairs Critical Monitoring

    Certain Philips Tempus Pro Patient Monitors may display an error message when laryngoscopes are disconnected, requiring a 60-100 second restart that prevents vital sign monitoring and airway visualization during intubation. This may lead to treatment delays or hypoxia.

    Product
    Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-2594-2023·2023-09-27

    SofTech Wheelchair Cushions Recalled for Defective Battery Overheating Risk

    Aquila Corporation is recalling 134 SofTech Pressure-Sensing Wheelchair Cushions with defective battery packs that can overheat, risking property damage and a possible injury. The affected units have been distributed nationwide in the US and internationally to Canada, Sweden, Romania, Australia, and the UK.

    Product
    SofTech Pressure-Sensing Wheelchair Cushions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1151-2023·2023-09-27

    FDA Recalls TRP Natural Eyes Eye Drops Due to Sterility Assurance Issue

    The FDA is recalling TRP Natural Eyes Aging Eye Relief eye drops due to lack of assurance of sterility. The affected lot DB001 (expiration 06/24) was distributed to accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502 NDC: 17312-027-15.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-1154-2023·2023-09-27

    TRP Natural Eyes sterile eye drops recalled for lack of sterility assurance

    TRP Natural Eyes Blur Relief eye drops are being recalled due to lack of assurance of sterility. The product was distributed to accounts in Rhode Island and Colorado.

    Product
    TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 mL), Manufactured in Jordan, exclusively for TRP Company, Inc., 1575 Delucchi Lane, Reno, NV 89502, NDC: 17312-002-11.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-1160-2023·2023-09-27

    FDA Recalls Eye Ointment Product Due to Sterility Assurance Failure

    The FDA is recalling Major LubriFresh PM eye ointment due to lack of assurance of sterility. Approximately 282,564 units were distributed to accounts in Rhode Island and Colorado.

    Product
    MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.125 OZ (3.5g), Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268, Made in Jordan, NDC: 0904-6488-38.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-1176-2023·2023-09-27

    Sunscreen Recall: Humanrace Ozone Body Protection Cream Lacks Declared SPF

    Humanrace Suncare Ozone Body Protection Cream SPF 30 does not contain the sun protection factor declared on the label. Approximately 2,942 units have been recalled.

    Product
    Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF 30, packaged as a 148mL (5 fl oz.) bottle, PA ++++, 100% mineral, Active Ingredient: Zinc oxide 15%, Snow Mushroom, Squalene, Aloe, Dist. By: @Humanrace 2022 Beverly Hills, CA 90210, USA, NDC 82779-002
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2621-2023·2023-09-27

    Smith & Nephew knee implant recall: wrong size in packaging

    Smith & Nephew recalled 8 knee implants from a specific lot after finding packages labeled as SIZE 5N contained SIZE 4N implants instead. Patients who received these implants should contact their surgeon immediately.

    Product
    smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2614-2023·2023-09-27

    Abbott Cardiac Defibrillators Recalled for Bluetooth Circuit Component Failure

    Abbott recalled certain ICD and CRT-D devices manufactured before April 2022 due to a Bluetooth malfunction from a crystal component defect in the BLE circuit. The malfunction causes loss of Bluetooth communication, and in some cases, excessive power drain affecting battery longevity.

    Product
    Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA500Q Neutrino VR Implantable Cardioverter Defibrillator: NxT VR ICD REF CDVRA600Q Neutrino DR Implantable Cardioverter…
    Category
    Medical Device
    Distribution
    0 states
  • HighUSDA FSIS·045-2023·2023-09-23

    Green Valley Foods Recalls Frozen Meat Pizzas Due to Undeclared Soy

    Green Valley Foods is recalling approximately 4,062 pounds of frozen meat pizza products because they contain soy, a known allergen, that is not declared on the label.

    Product
    Green Valley Foods — Green Valley Foods Recalls Frozen Meat Pizza Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·23V649000·2023-09-22

    2023 Kia Forte Right Front Control Arm Defect Recall

    Kia is recalling 2023 Forte vehicles due to improper welds on the right front lower control arm, which may fail and cause loss of steering control. Affected owners should not drive the vehicle until repaired.

    Product
    KIA — KIA FORTE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V648000·2023-09-22

    2024 East to West RV Recall: Detachable Rear Ladder Poses Injury Risk

    Forest River is recalling certain 2024 East to West Blackthorn and Tandara fifth wheels. The rear ladder may detach due to improper anchoring, creating a potential injury risk.

    Product
    EAST TO WEST — EAST TO WEST TANDARA, BLACKTHORN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·23V650000·2023-09-22

    2024 Hyundai Kona Seat Belt Retractor Malfunction Recall

    Hyundai is recalling certain 2024 Kona vehicles because the rear seat belt retractors may not function properly. A defective seat belt could fail to restrain occupants in a crash, increasing injury risk.

    Product
    HYUNDAI — HYUNDAI KONA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·23293·2023-09-21

    H&M Men's Clasp Beaded Bracelets Recalled for High Lead Content

    H&M is recalling about 12,290 men's clasp beaded bracelets because the clasp contains lead levels exceeding the federal ban. Lead is toxic if ingested by young children and can cause adverse health effects.

    Product
    Men's clasp beaded bracelets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23291·2023-09-21

    DR Power Chipper Shredders Recalled Due to Laceration Hazard

    DR Power Chipper Shredders are being recalled because metal pieces can come loose and be ejected, or the hopper can detach, both creating laceration hazards. The firm has received 79 reports of parts coming loose and 3 reports of hopper detachment, with a total of 3 reported injuries.

    Product
    DR Power Chipper Shredders
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23793·2023-09-21

    Novaform ComfortGrande and DreamAway Mattresses Recalled for Mold Contamination

    FXI recalls about 48,000 Novaform mattresses from Costco due to mold contamination from water exposure during manufacturing. The mold poses a health risk to people with compromised immune systems or mold allergies. No injuries have been reported.

    Product
    Novaform ComfortGrande 14-inch and Novaform DreamAway 8-inch Mattresses
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23292·2023-09-21

    Rainbow Road Series Board Books Recall: Detachable Plastic Rings Choking Hazard

    Make Believe Ideas recalls seven Rainbow Road Series board books because plastic binding rings can detach, posing a choking hazard to young children. About 260,000 units were sold nationwide from March 2022 through August 2023.

    Product
    Rainbow Road Series Board Books
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1501-2023·2023-09-20

    Cream Cheese Rangoon Recalled Due to Plastic Foreign Object

    Pegasus Foods, Inc. is recalling Cream Cheese Rangoon due to the presence of plastic foreign objects in the product. Approximately 38,887 cases distributed in California are affected.

    Product
    Cream Cheese Rangoon NET WT: 5.00 LB. (2.26 KG) CT/CS: 100 PS (5 TRAYS X 20 PCS UPC: (01)10664383187016(15)112823(10)0601233A1W package in corrugated cardboard case.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2571-2023·2023-09-20

    Landauer nanoDot dosimeters recalled for potential accuracy deviation

    Landauer has recalled nanoDot radiation dosimeters due to potential accuracy deviations in the Optical Stimulated Luminescence material used to measure radiation exposure. Affected units may read outside the specified +/-5.5% accuracy range.

    Product
    Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002); b) 18150-KIT; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-1148-2023·2023-09-20

    Pantoprazole Sodium for Injection Recalled Due to Sterility Concern

    BE Pharmaceuticals is recalling Pantoprazole Sodium for Injection nationwide due to lack of sterility assurance caused by powder discoloration and small cracks in some vials. No illnesses have been reported.

    Product
    PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2574-2023·2023-09-20

    NanoDots radiation dosimeter recalled for potential measurement accuracy issues

    Landauer is recalling NanoDots radiation monitoring dosimeters because some units may not meet specified accuracy of +/-5.5% due to a defect in the luminescence material.

    Product
    NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1512-2023·2023-09-20

    US Foods Peanut Butter Toffee Bar recalled for possible plastic contamination

    Killer Brownie Ltd is recalling US Foods Peanut Butter Toffee Bars (3.4oz) distributed in Illinois due to possible plastic foreign material. Consumers should not eat affected units.

    Product
    US Foods: Peanut Butter Toffee Bar, 3.4oz unit size, packaged in flow wrap, 24 packages per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2553-2023·2023-09-20

    Radiation Dosimeter Kit Recalled Due to Potential Accuracy Drift

    Landauer is recalling nanoDot radiation dosimeter kits (16,760 units distributed worldwide) because some units may measure radiation exposure outside specified accuracy tolerances, potentially affecting dose measurement accuracy.

    Product
    nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2587-2023·2023-09-20

    Philips X-Ray Systems Recalled for Foot Switch Malfunction Risk

    Philips Allura and Azurion x-ray imaging systems are being recalled due to a damaged foot switch component that may prevent or intermittently disable x-ray radiation initiation. Approximately 19,115 systems are affected worldwide.

    Product
    Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
    Category
    Medical Device
    Distribution
    0 states