The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

6951–6975 of 26961

  • HighFDA (Food)·F-0604-2025·2025-03-12

    Coconut Rolls Recalled Due to Undeclared Milk Allergen

    Jesse's Bakery is recalling Pan de Coco coconut rolls distributed in Hawaii because they contain undeclared milk, a common allergen that could harm people with milk allergies.

    Product
    Pan de Coco (Coconut Rolls), net wt. 9oz (255g), product is packaged as 6 rolls on a yellow styrofoam plate, then placed in a flexible poly bag with printed label on bag. Product label states Jesse s BAKERY, INC 1101 N. King Street Phone: 842-1120/842-1121 Honolulu, Hawaii 96817
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0601-2025·2025-03-12

    King Harvest Hummus Recalled for Plastic Fragment Contamination

    Pacific Coast Fresh CO recalled King Harvest Toasted Onion Hummus for possible plastic fragments. Affected product was distributed in Idaho, Oregon, and Washington.

    Product
    Item #96524, King Harvest Toasted Onion Hummus, net wt. 10oz., UPC 025726 31129 2, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon.
    Category
    Food
    Distribution
    0 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
  • 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
    0 states
  • 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 (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 (Devices)·Z-1260-2025·2025-03-12

    Medtronic MiniMed Insulin Pumps Recalled for Abnormal Delivery During Air Pressure Changes

    Medtronic is recalling MiniMed insulin pumps that malfunction during airplane takeoff and landing due to air pressure changes. The defect can cause abnormal insulin delivery, leading to severe hypoglycemia, hyperglycemia, seizure, coma, or death.

    Product
    MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
    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-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-0602-2025·2025-03-12

    Food Recall: Plastic Fragments in King Harvest Toasted Sesame Hummus

    Pacific Coast Fresh CO is recalling King Harvest Toasted Sesame Hummus (10oz) due to plastic fragments. Affected products were distributed in Idaho, Oregon, and Washington with expiration dates from February 3 to 23, 2025.

    Product
    Item #96526 and item #32900, King Harvest Toasted Sesame Hummus, net wt. 10oz., UPC 025726 31122 3, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1270-2025·2025-03-12

    Philips BGM 4 Blood Glucose Meter Battery Expansion Risk Recall

    Telcare recalls 34,764 Philips BGM 4 blood glucose meters (Model TM0009) nationwide due to battery expansion and swelling. The battery may cause the back cover to separate or, in worst-case scenarios, explode. No injuries reported to date.

    Product
    Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1291-2025·2025-03-12

    DeRoyal Suction Connector Tubing Recalled for Assembly and Function Issues

    DeRoyal suction connector tubing in five U.S. states has been recalled because the connector's inner diameter is smaller than the suction canister lid port, making assembly difficult and risking inadequate suction and delayed patient care.

    Product
    DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tubing, Suction, Connector; DeRoyal REF 71-C7100NS Tubing, Suction, Connector Indicated use - Fluid Movement
    Category
    Medical Device
    Distribution
    5 states
  • 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-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
  • 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-1295-2025·2025-03-12

    AURORA Surgiscope System Obturator May Break or Separate

    Integra LifeSciences Corp. is recalling AURORA Surgiscope Systems (models ASX15/60 and ASX15/80) because the obturator component may break or separate during surgical use. Healthcare facilities should discontinue use and contact the manufacturer for instructions.

    Product
    AURORA Surgiscope System, Sterile, single use device that contains a Sheath, Obturator, and Imager. Manufacturer's Product Numbers (Catalog Number): (1) ASX15/60 and (2) ASX15/80
    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 (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-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 (Drugs)·D-0254-2025·2025-03-12

    Morphine Sulfate Oral Syringes Recalled for Defective Delivery System Leakage

    Safecor Health is recalling Morphine Sulfate 5 mg oral syringes nationwide due to leakage in the delivery system following repackaging. No illnesses have been reported.

    Product
    Morphine Sulfate 5 mg per 0.25 mL Oral Syringe, Delivers: 0.25 mL, Oral Solution, Rx Only, Mfg by: Hikma, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: a) 00406800312, b) 00406800330, c) 00054051750.
    Category
    Drug
    Distribution
    Distributed nationwide
  • 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
    0 states
  • HighFDA (Devices)·Z-1249-2025·2025-03-12

    Access Erythropoietin Reagent Lot Produces Falsely Decreased Test Results

    Beckman Coulter's Access Erythropoietin (EPO) reagent lot 439363 produces falsely decreased test results with patient samples. Affected results may lead to improper diagnosis or unnecessary repeat testing.

    Product
    Access Erythropoietin (EPO), Catalog Number - A16364 a glycoprotein (~30,400 Daltons) produced primarily by the kidney, is the principal factor regulating red blood cell production (erythropoiesis) in mammals. Renal production of EPO is regulated by changes in oxygen availabil
    Category
    Medical Device
    Distribution
    24 states
  • 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-0595-2025·2025-03-12

    Hummus Recall: Plastic Fragments in King Harvest Jalapeno Hummus

    Pacific Coast Fresh Co is recalling 10,374 cups of King Harvest Jalapeno Hummus due to plastic fragments. The affected product was distributed in Idaho, Oregon, and Washington with expiration dates in February and March 2025.

    Product
    Item #96521, item #32896, and item #32898, King Harvest Jalapeno Hummus, net 10oz., UPC 025726 31004 2, perishable and refrigerated, packed in sealed plastic tub and lid. Exclusively by Pacific Coast Fresh Co Portland, Oregon.
    Category
    Food
    Distribution
    0 states