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.

6976–7000 of 26961

  • HighFDA (Food)·F-0596-2025·2025-03-12

    King Harvest Lemon Hummus Recalled for Plastic Fragment Contamination

    King Harvest Lemon Hummus (10 oz) is being recalled due to possible plastic fragments in the product. The voluntary recall affects approximately 2,084 cups distributed in Idaho, Oregon, and Washington.

    Product
    Item #96522, King Harvest Lemon Hummus, net wt. 10oz., UPC 025726 31001 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-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-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 (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
  • ModerateFDA (Devices)·Z-1252-2025·2025-03-12

    Philips IntelliSpace Cardiovascular Software Data Archival Failure Recall

    Philips cardiovascular diagnostic software version 7.0.0.0 cannot archive, copy, or export study data, affecting 139 units distributed nationwide. Users may experience data management and workflow disruptions.

    Product
    Philips IntelliSpace Cardiovascular software, Model 830089.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0250-2025·2025-03-12

    Vitamin D Supplement Oral Syringes Recalled for Defective Delivery System

    Safecor Health is recalling 3069 units of Ergocalciferol (Vitamin D Supplement) oral syringes nationwide due to leakage in the repackaged unit-dose delivery system. No illnesses have been reported.

    Product
    Ergocalciferol - Vitamin D Supplement - 10 mcg (400 Units) per 0.05 mL Oral Syringe, Delivers: 0.05 mL Oral Solution, Mfg by: Westminster, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 69367028302.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1292-2025·2025-03-12

    Vios bedside monitor batteries may deplete during storage

    Murata Vios bedside monitors may experience battery depletion if stored without power, causing tablet connectivity issues. Affected units should be kept plugged in while in storage.

    Product
    Vios Monitoring System Bedside Monitor Model BSM2050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1290-2025·2025-03-12

    Lumenis Pulse 120H Laser System Charger May Prevent Device Startup

    Lumenis recalled three Pulse 120H laser systems due to a charger defect. The charger's initial current can damage AC controller power resistors, preventing the device from powering on.

    Product
    (1) Lumenis Pulse 120H 30 amp, REF GA 2009996, Laser System; (2) Lumenis Pulse 120H, Moses 2.0 (DOM), REF GA0006802, Laser System; and (3) Lumenis Pulse 120H, REF GA-0008700, Laser System.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0251-2025·2025-03-12

    Simethicone Oral Syringe Recalled for Defective Delivery System

    Safecor Health is recalling Simethicone 20 mg oral syringes due to leakage caused by a defective delivery system. Approximately 10,992 syringes were distributed nationwide.

    Product
    Simethicone 20 mg per 0.3 mL Oral Syringe, Delivers: 0.3 mL, Oral Drops, Mfg By: Rugby, Pkg by: Safecor Health, LLC, Columbus, OH 43204, NDC: 00536130375.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1275-2025·2025-03-12

    ET Rigid and Multi Dental Abutments Recalled for Incorrect Identification Stickers

    Hiossen recalled ET Rigid and Multi dental abutments for incorrect identification stickers in packaging that misidentify product versions, risking improper placement during installation.

    Product
    ET Rigid Abutment (Mini) Size: 4.5D 2.0G/H 4.0H- Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4524MP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0603-2025·2025-03-12

    Noble Made Garlic Parmesan Wing Sauce recalled for foaming issue

    Noble Made Garlic Parmesan Wing Sauce is being recalled due to customer complaints of bottles foaming when opened. The product was distributed to retail locations across multiple states.

    Product
    Noble Made Garlic Parmesan Wing Sauce, net wt 9.25oz, UPC 850000398542, #0897 BEST BY 06/02/2026 14:02 33724 L1, Code: F20920061
    Category
    Food
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-1296-2025·2025-03-12

    BD BBL TB Stain Kit Expiration Date Labeling Discrepancy

    BD BBL TB Stain Kit component shipped with incorrect expiration date labeling. One component has printed expiration 30 September 2024 while Certificate of Analysis indicates 30 April 2025, creating confusion about product validity.

    Product
    BD BBL TB Stain Kit K, Catalog (REF): 212522
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-1251-2025·2025-03-12

    Infiltration Cannula Recalled Due to Incorrect Water Jet Pattern

    HUMAN MED AG is recalling 775 Biofill Infiltration Cannulas because the water jet may emerge as a spot jet rather than the specified fan-shaped spray pattern, affecting device functionality.

    Product
    human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0643-2025·2025-03-12

    Orgeat Almond Syrup Recalled Due to Potential Yeast Contamination

    A C Calderoni & Co. Inc. is recalling Orgeat Almond Syrup due to potential yeast contamination in the product. The affected product was distributed to foodservice distributors and restaurants in California.

    Product
    ORGEAT ALMOND SYRUP; 32 fl oz (946 ml); Glass bottle with screw-top lid; Contains: Sugar, Water, Citric Acid Natural Flavor, Sodium Benzoate; Refrigerate after opening
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1272-2025·2025-03-12

    Dental abutment implants recalled for incorrect patient chart stickers

    Hiossen Inc. is recalling ET Rigid Abutment (Mini) dental implant components due to patient chart stickers that incorrectly identify the product version. The stickers may identify Mini versions as Regular, or Multi-versions as Mini.

    Product
    ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4537MP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1271-2025·2025-03-12

    Dental implant abutments recalled for incorrect packaging labels

    Hiossen has recalled ET Rigid Abutment dental implant components because stickers in the packaging mislabel whether products are Mini or Regular versions. Incorrect identification could affect proper implant installation.

    Product
    ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. GA4515MP Model/Catalog Number: ETRGA4515MP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1273-2025·2025-03-12

    Dental Abutments Recalled for Incorrect Version Identification Stickers

    Hiossen Inc. is recalling ET Rigid Abutments due to incorrect patient chart stickers that misidentify product versions. The stickers may label Mini abutments as Regular or identify other abutment models incorrectly, risking use of the wrong component.

    Product
    ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4544MP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1274-2025·2025-03-12

    Hiossen Dental Abutments Misidentified on Patient Chart Stickers

    Hiossen is recalling patient chart stickers for dental abutments that incorrectly identify product versions. Stickers mislabel ET Rigid Abutments as Regular and ET Multi Abutments as Mini. Dentists should verify actual product versions against packaging labels.

    Product
    Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA503RV1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0578-2025·2025-03-05

    Gerber Baby Teething Sticks Recalled Due to Choking Risk

    Nestlé-USA is recalling all lots of Gerber Snacks for Baby Soothe 'n' Chew Teething Sticks in Strawberry Apple flavor following complaints of infant choking. The product was distributed across 42 states and Puerto Rico.

    Product
    Gerber Snacks for Baby Soothe 'n' Chew TEETHING STICKS Strawberry Apple NET WT 3.2 OZ (90g) UPC 0 15000 04518 7 GERBER PRODUCTS CO., FREMONT, MI 49413
    Category
    Food
    Distribution
    45 states
  • SevereFDA (Food)·F-0577-2025·2025-03-05

    Garden Salad Recalled for Undeclared Peanut Allergen in Florida and Georgia

    FRESHPOINT CENTRAL FLORIDA, INC. is recalling Garden Salad 5 oz packages due to undeclared peanut allergen. The affected product was distributed in Florida and Georgia.

    Product
    Garden Salad 5 oz Lot # 6620223 Best By: 02.05, UPC 766375733300
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0572-2025·2025-03-05

    Mombo's Vanilla Soft Serve Ice Cream Mix Recalled for Undeclared Egg Allergen

    Arizona Foods Group is recalling Mombo's Vanilla Soft Serve Ice Cream Mix because it may contain egg, an undeclared allergen. Consumers with egg allergies should not consume this product.

    Product
    FOOD SERVICE - Mombo s Vanilla Soft Serve Ice Cream Mix, frozen & thawed for Ice cream machines. Packaged in a half gallon carton 64 oz and placed in cases of 6-units. Shelf-life is 18 months frozen / 30 days thawed refrigerated. Carton is a plain white carton with a sticker
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0579-2025·2025-03-05

    Gerber Baby Soothe 'n' Chew Teething Sticks Recalled for Choking Risk

    Gerber Snacks for Baby Soothe 'n' Chew Teething Sticks in Banana flavor are recalled nationwide due to complaints of infant choking. All lots in both 1.59 oz and 3.2 oz packages are affected.

    Product
    Gerber Snacks for Baby Soothe 'n' Chew TEETHING STICKS Banana NET WT 3.2 OZ (90g) box UPC 0 15000 04608 8 and NET WT 1.59 oz box UPC 0 15000 01015 7 GERBER PRODUCTS CO., FREMONT, MI 49413
    Category
    Food
    Distribution
    45 states
  • SevereFDA (Devices)·Z-1196-2025·2025-03-05

    Ventec VOCSN Ventilators Recalled Due to Incorrect Service Parts

    Ventec Life Systems recalled VOCSN Multi-Function Ventilators (30 units in CA, NY, MO) due to incorrect parts used during service. Defects may cause unexpected shutdown or impaired respiratory monitoring and support.

    Product
    VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1236-2025·2025-03-05

    Video Colonoscope May Cause Thermal Burns to Tissue During Use

    The PENTAX Medical Video Colonoscope (Model EC38-i20cL) can develop excessive heat at the tip during procedures, potentially causing thermal burns to patient tissue. Users reported dark images and steam-like smoke from the device.

    Product
    PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EC38-i20cL
    Category
    Medical Device
    Distribution
    Distributed nationwide