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.

5101–5125 of 52956

  • HighFDA (Devices)·Z-1265-2025·2025-03-12

    MiniMed Insulin Pump May Malfunction at High Altitude During Flight

    Medtronic MiniMed insulin pumps may deliver abnormal insulin doses during airplane takeoff or landing due to air pressure changes, potentially causing severe low or high blood sugar.

    Product
    MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1261-2025·2025-03-12

    Medtronic MiniMed insulin pump recalled for air pressure-triggered delivery defect

    Medtronic MiniMed insulin pumps can deliver abnormal insulin doses during air pressure changes in airplane travel, risking severe hypoglycemia or hyperglycemia and serious complications.

    Product
    MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1268-2025·2025-03-12

    Heat Moisture Exchanger Connector Occlusion May Impair Ventilation

    Kung Shin Plastics' CircuitGuard ThermoFlo Filter may have plastic obstructing the machine-side connector, preventing proper ventilation bag operation and risking oxygen deprivation during manual ventilation.

    Product
    CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1266-2025·2025-03-12

    Medtronic MiniMed insulin pumps may deliver abnormal insulin doses during flight

    Medtronic MiniMed insulin pumps may deliver abnormal doses of insulin during airplane takeoff or landing due to air pressure changes. This can result in severe hypoglycemia or hyperglycemia, with potential for seizure, coma, or death.

    Product
    MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0592-2025·2025-03-12

    King Harvest Black Olive Hummus Recalled Due to Plastic Fragments

    King Harvest Black Olive Hummus (10 oz) has been recalled due to the presence of plastic fragments. The voluntary recall affects 4,019 cups distributed in Idaho, Oregon, and Washington.

    Product
    Item #96514 and item #32903, King Harvest Black Olive Hummus, net wt. 10oz., UPC 025726 31121 6, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1250-2025·2025-03-12

    TBS iNsight bone density software calculation variability on Hologic machines

    TBS iNsight medical device software may produce inconsistent calculation results when operating on Hologic Horizon bone densitometers, particularly when comparing fast array scans to standard array scans.

    Product
    Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0 Product Description: TBS iNsight is a class II Medical Device software that is installed on bone densitom
    Category
    Medical Device
    Distribution
    23 states
  • HighNHTSA·25V155000·2025-03-12

    Land Rover Recalls 2025 Range Rovers for Seat Belt Defect

    Jaguar Land Rover is recalling 2025 Range Rover and Range Rover Sport vehicles because the second-row center seat belt buckle may not latch correctly.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER, RANGE ROVER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1293-2025·2025-03-12

    Alcon Custom Pak surgical packs mislabeled as latex-free despite containing latex

    Alcon surgical procedure packs contain latex but are labeled as latex-free, creating risk of allergic reaction for patients with latex sensitivity. The company is recalling 2,511 affected units.

    Product
    Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12698-09, 15632-10, 3141-45, 12630-07, 18925-05, 19265-05, 13894-16, 17550-08, 12236-18, 11854-15, 8043-29, 12466-17, 15599-17, 14764-09, 13194-16, 17069-09
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1262-2025·2025-03-12

    Medtronic MiniMed insulin pump recalled for abnormal delivery during air pressure changes

    Medtronic MiniMed insulin pumps may deliver insulin abnormally during airplane take-off or landing due to air pressure changes, risking severe low or high blood sugar emergencies.

    Product
    MiniMed insulin pump, REF: 700G (MMT-1801, MMT-1805, MMT-1850, MMT-1851)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0600-2025·2025-03-12

    Food Recall: King Harvest Sundried Tomato Hummus, Plastic Fragments

    Pacific Coast Fresh Co is recalling King Harvest Sundried Tomato Hummus due to potential plastic fragment contamination. The product was distributed in Idaho, Oregon, and Washington.

    Product
    Item #96528 and 32899, King Harvest Sundried Tomato Hummus, net wt. 10oz., UPC 025726 31118 6, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0584-2025·2025-03-12

    Biostime Kids Calm & Sleep Support Gummies Recalled for Metal Ball Contamination

    Health and Happiness LLC is recalling Biostime Kids Calm & Sleep Support Fruity Bites gummies due to tiny non-magnetic metal balls inside the product. The affected lot poses a choking hazard to children.

    Product
    Biostime Kids Calm & Sleep Support Fruity Bites Probiotics and Prebiotics Fiber Sachets (gummies), Flexible Sachet packaging, Sample size package (4 Count), EXP: JUL/2025 Lot : 2413352PSF
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0597-2025·2025-03-12

    Roasted Pepper Hummus Recalled for Potential Plastic Fragment Contamination

    Pacific Coast Fresh Co is recalling King Harvest Roasted Pepper Hummus due to potential plastic fragment contamination. The voluntary recall affects 9,535 units distributed in Idaho, Oregon, and Washington.

    Product
    Item #96525 and item #32897, King Harvest Roasted Pepper Hummus, net wt. 10oz., UPC 025726 31127 8, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0256-2025·2025-03-12

    Nelarabine prescription injection recalled due to failed quality specifications

    Zydus Pharmaceuticals is recalling 1,893 vials of Nelarabine Injection (250 mg/50 mL) due to failed quality specifications for impurities and degradation. Patients should contact their healthcare provider about the recall.

    Product
    NELARABINE — NELARABINE (NELARABINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1256-2025·2025-03-12

    Medtronic Paradigm insulin pump recall for abnormal delivery during flight

    Medtronic MiniMed Paradigm insulin pumps may deliver incorrect insulin doses during airplane takeoff or landing due to air pressure changes. This can cause severe high or low blood sugar requiring immediate medical attention.

    Product
    Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0593-2025·2025-03-12

    Hummus Recall: Plastic Fragments Found in King Harvest Chipotle Hummus

    Pacific Coast Fresh CO is recalling 1953 cups of King Harvest Chipotle Hummus due to potential plastic fragments in the product. The affected hummus was distributed in Idaho, Oregon, and Washington.

    Product
    Item #96517, King Harvest Chipotle Hummus, net wt. 10oz., UPC 025726 31007 3, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0591-2025·2025-03-12

    Hummus Recall: Plastic Fragments in King Harvest Balsamic Hummus

    Pacific Coast Fresh CO is recalling King Harvest Balsamic Hummus due to the presence of plastic fragments. The recall affects products distributed in Idaho, Oregon, and Washington with expiration dates in February 2025.

    Product
    Item #96507 and item# 32901, King Harvest Balsamic Hummus, net wt. 10oz., UPC 025726 310097, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1264-2025·2025-03-12

    MiniMed Insulin Pump Models Recalled for Abnormal Delivery During Flight

    Medtronic is recalling MiniMed insulin pumps due to air pressure changes during airplane takeoff and landing that can cause abnormal insulin delivery. Overdoses risk severe hypoglycemia; underdoses risk severe hyperglycemia and diabetic ketoacidosis.

    Product
    MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1255-2025·2025-03-12

    Medtronic Paradigm insulin pumps may deliver incorrect doses during flight

    Medtronic MiniMed insulin pumps may deliver abnormally high or low insulin doses in response to air pressure changes during airplane takeoff and landing, potentially causing severe hypoglycemia or hyperglycemia.

    Product
    Paradigm REF: MMT-712 and MMT-715
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1294-2025·2025-03-12

    Tissue Approximation System zip-ties at risk of breaking during implantation

    TAS Medical is recalling Tissue Approximation System models because tissue approximation straps (zip-ties) may break before or during surgery. Undetected breaks could lead to hernia recurrence requiring additional corrective surgery.

    Product
    TISSUE APPROXIMATION SYSTEM (TAS), Models T-4000, T-5000, T-LAP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1259-2025·2025-03-12

    MiniMed Insulin Pumps Recalled for Abnormal Insulin Delivery During Flight

    MiniMed insulin pumps may deliver abnormal insulin doses during aircraft takeoff and landing due to air pressure changes, risking severe blood sugar fluctuations, seizures, and potentially fatal complications.

    Product
    MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0599-2025·2025-03-12

    Spinach hummus recalled for plastic fragment contamination

    Pacific Coast Fresh Co is recalling King Harvest Spinach Hummus due to plastic fragment contamination. Affected products were distributed in Idaho, Oregon, and Washington with expiration dates in February 2025.

    Product
    Item #96527 and item #32902, King Harvest Spinach Hummus, net wt. 10oz., UPC 025726 31108 7, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0598-2025·2025-03-12

    King Harvest Roasted Garlic Hummus recalled for plastic fragment contamination

    King Harvest Roasted Garlic Hummus is being recalled for possible plastic fragment contamination. The voluntary recall affects 9,588 cups distributed in Idaho, Oregon, and Washington.

    Product
    Item #96520 and item #32898, King Harvest Roasted Garlic Hummus, net wt. 10oz., UPC 025726 21114 1, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0252-2025·2025-03-12

    Ferrous Sulfate Oral Syringes Recalled Due to Leakage Defect

    Safecor Health is recalling 1535 Ferrous Sulfate 7.5 mg oral syringes distributed nationwide due to leakage observed during repackaging. The defective delivery system could result in improper dosing of the iron supplement.

    Product
    Ferrous Sulfate 7.5 mg Iron/0.5 mL Oral Syringe, Delivers: 0.5 mL, Iron Supplement Drops, Mfg by: Akron Pharma, Pkg by: Safecor, Columbus, OH 43204. NDC: a) 71399748005, b) 39328055750, c) 69618007059.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0594-2025·2025-03-12

    Food recall: King Harvest Hummus affected by plastic fragments

    Pacific Coast Fresh Co recalled King Harvest Classic Hummus because plastic fragments were found in the product. Approximately 10,142 cups were distributed in Idaho, Oregon, and Washington.

    Product
    Item #96518 and #32895, King Harvest Classic Hummus, net wt. 10oz., UPC 025726 31110 0, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1269-2025·2025-03-12

    CircuitGuard Bacterial/Viral Filter Recalled for Plastic Connector Obstruction

    Kung Shin Plastics is recalling 30,000 units of CircuitGuard Bacterial/Viral Filter with Elbow (Model SK200FPE/7056) due to plastic occlusion in the connector that prevents airflow and causes ventilation bag malfunction, risking oxygen deprivation and respiratory distress.

    Product
    CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
    Category
    Medical Device
    Distribution
    Distributed nationwide