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.

10301–10325 of 27089

  • HighFDA (Devices)·Z-2433-2024·2024-07-31

    Infusion Pump Syringe Compatibility Issue May Cause Overdose or Underdose

    B Braun is recalling Perfusor Space infusion pumps due to syringe compatibility issues with Cardinal Health Monoject syringes. The incompatibility may cause overdose, underdose, therapy delays, and alarm failures.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product Description: Perfusor Space Infusion Pump System, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2431-2024·2024-07-31

    Abbott Infinity 7 Pulse Generator May Have Shorter-Than-Labeled Service Date

    The Abbott Infinity 7 implantable pulse generator's replacement indicator and end-of-service date may be shorter than the product labeling states, potentially leading to loss of therapy for patients.

    Product
    Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1494-2024·2024-07-31

    Signature Blue Canned Crab Recalled for Improper Temperature Control

    Pacific Shellfish, Inc. is recalling Signature Blue Swimming Crab Claw and Lump canned crab (lots #78821 and #788454) from California due to storage at temperatures above 40°F without ice as of July 1, 2024.

    Product
    Signature Blue Swimming Crab Claw and Lump 1lb can Tin Can, Lot # 78821 Expiration June 09th 2026, Lot # 788454 Expiration June 09th 2026
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1490-2024·2024-07-31

    Organic Aussie Bites recalled for undeclared gluten content

    Best Express Foods is recalling Universal Bakery Organic Aussie Bites due to undeclared gluten. Products labeled as gluten-free were found to contain gluten above regulatory limits.

    Product
    Universal Bakery Organic Aussie Bites, 30 oz clamshell container USDA Organic Certified Gluten Free Rolled Oats, Dried Apricots, Flax Seeds, Sunflower Seeds, Honey, Coconut, Quinoa, Chia Seeds + More! INGREDIENTS: Organic Rolled Oats, Organic Oat Flour, Organic Invert Cane Sugar
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-2445-2024·2024-07-31

    LINK SymphoKnee Patella Sizing Template recalled due to incorrect markings

    LINK BIO CORP is recalling the LINK SymphoKnee Patella Sizing Template (Item Number 881-509/00, Lot C225066) because markings on two arms of the instrument were mixed up during manufacturing.

    Product
    LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2429-2024·2024-07-31

    Abbott Infinity 5 Pulse Generator May Have Inaccurate Battery-Life Labels

    Abbott Infinity 5 implantable pulse generators have inaccurate end-of-service dates in labeling, which may result in loss of therapy. Approximately 5,900 units are affected and distributed worldwide.

    Product
    Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0616-2024·2024-07-31

    Hemp Bombs CBD Pain Freeze Recalled for Subpotent Menthol Content

    Hemp Bombs CBD Pain Freeze is being recalled because the menthol content is weaker than the labeled 4% claim. The recall affects 2,082 bottles distributed nationwide.

    Product
    Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC Code: 8-40078-56612-7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2439-2024·2024-07-31

    Medical device diagnostic software vulnerability causes potential application crashes

    Siemens Sensis Vibe diagnostic systems may crash when documentation functionality is used during certain reporting events. Seven units were distributed to facilities nationwide.

    Product
    Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0614-2024·2024-07-31

    Nature's Script CBD Pain Relief Roll-On Recalled for Subpotent Menthol

    FDA Class III recall of Nature's Script CBD Cryotherapy Pain Relief Roll-on (200mg, 1 oz bottles) due to subpotent menthol content less than the labeled 4%. The product did not contain the claimed amount of active ingredient.

    Product
    Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, UPC code: 8-40078-56731-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2422-2024·2024-07-31

    MIC-KEY Gastric-Jejunal Feeding Tube Kits Recalled for Incomplete Safety Information

    Avanos Medical is recalling MIC-KEY Gastric-Jejunal Feeding Tube Kits because the Instructions for Use were missing required risk information about potential complications. No illnesses have been reported.

    Product
    MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Extension Sets with ENFit Connectors, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 8270xx, ste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1492-2024·2024-07-31

    Dried Plums Recalled for Undeclared Cyclamate Content

    Sweet Preserved Dried Plums from Farmer's Grange contain undeclared cyclamate sweetener. The product was distributed in select U.S. states and should not be consumed.

    Product
    Sweet Preserved Dried Plums; Farmer's Grange; Series Food; 88g; Plastic synthetic (flexible) package; INGREDIENTS: Plum, Salt, Sugar, ADDITIVES: Clove, Cinnamon, Liquorice, Citric acid, Red #40.; Product contains sulfite; PRODUCT OF CHINA (T.F.C).
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0613-2024·2024-07-31

    Hemp Bombs CBD Pain Freeze Recalled Due to Subpotent Menthol Content

    Hemp Bombs CBD Pain Freeze is being recalled because the menthol potency is less than the labeled 4%. Consumers should stop using the affected product and return it to the retailer.

    Product
    Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634, NDC 73423-003-01; UPC Code: 8-40078-56493-2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2425-2024·2024-07-31

    Cystatin C Diagnostic Reagent Marketed Without FDA 510(k) Clearance

    Randox Laboratories is recalling 115 kits of RX Series CYSC Cystatin C Reagent because it was marketed without required FDA 510(k) clearance. Healthcare facilities should discontinue use and contact the manufacturer.

    Product
    RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0615-2024·2024-07-31

    Hemp Bombs CBD Pain Freeze Recalled Due to Subpotent Menthol Content

    Global Widget LLC is recalling Hemp Bombs CBD Pain Freeze (4% menthol) because the menthol concentration is below the labeled claim. Approximately 11,130 bottles were distributed nationwide.

    Product
    Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 33634; UPC code: 8-40078-56497-0
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0618-2024·2024-07-31

    Homeopathic Kit Recalled for Label Mix-up Between Products

    Washington Homeopathic Products is recalling 11 Complete 30C/200C Homeopathic Kits nationwide due to a labeling error. Some bottles labeled as Ferrum Metallicum 200C actually contain Ferrum Phosphoricum 200C.

    Product
    Complete 30C/200C Homeopathic Kit, Contains: One hundred 1/2 dram vials of homeopathic medicines, Washington Homeopathic Products, Inc., Berkley Springs, WV 25411, UPC 7 40640 64300 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2319-2024·2024-07-24

    Abiomed Impella CP with SmartAssist heart pump units recalled for failed inspection

    Abiomed is recalling 9 Impella CP with SmartAssist heart pump units that failed inspection and were inadvertently released. The devices were distributed in Florida, Massachusetts, Ohio, and Texas.

    Product
    Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
    Category
    Medical Device
    Distribution
    4 states
  • CriticalFDA (Food)·F-1483-2024·2024-07-24

    Deluxe Roasted Salted Mixed Nuts recalled for undeclared peanut allergen

    DSD Merchandisers recalls Deluxe Roasted Salted Mixed Nuts (Item 99651) for undeclared peanut allergen, with distribution in six western states and a sell-by date of October 9, 2024. Consumers with peanut allergies should not consume this product.

    Product
    Deluxe Roasted Salted Mixed Nuts ITEM NUMBER 99651 UPC: 6-51433-99651-6 SELL BY: 10/09/2024
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-2321-2024·2024-07-24

    Ventilation Device Handset Plug May Disconnect from Nebulizer Adapter

    Baxter's Volara System SPU circuit kits may have a faulty handset plug that disconnects from the nebulizer adapter, preventing proper ventilator gas flow.

    Product
    Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1478-2024·2024-07-24

    Power Greens Products Recalled Due to Listeria monocytogenes Contamination Risk

    Solata Food LLC is recalling multiple Power Greens products due to potential Listeria monocytogenes contamination. Affected products were distributed in NY, NJ, and NH with expiration dates of 6/20/24 and 6/24/24.

    Product
    1. Greens Full Circle Organic Power Greens; 6x10 Clamshell; UPC: 036800490550 / 2. Greens Gaia Organic Power Greens; 8x45 clamshell; UPC: 850021494889 / 3. Greens Full Circle Organic Power Greens; 8x5 clamshell; UPC: 036800388758 / 4. Greens Solata Power Greens; 8x5 Clamshell; U
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1493-2024·2024-07-24

    Aahu Barah Apricot Roll recalled for undeclared elevated sulfites

    Aahu Barah Apricot Roll (14 oz, UPC 882475000279) is being recalled because it contains elevated levels of undeclared sulfites. Consumers with sulfite sensitivity should not consume this product.

    Product
    Aahu Barah Apricot Roll; 14 oz; sold in clear plastic bags (6 inch x 8 inch) packing with the Aaha Barah label on the front and back; the product is labeled "Apricot Roll" on both the front and back; UPC 882475000279; label states "May Contain Sulfites As preservatives"
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-1479-2024·2024-07-24

    Greens products recalled for potential Listeria monocytogenes contamination

    Solata Food LLC is recalling multiple brands of greens products distributed in NY, NJ, and NH due to potential Listeria monocytogenes contamination. Affected products, totaling 4,382 lbs with expiration dates of June 20–24, 2024, should not be consumed.

    Product
    1. Greens Solata 5050; 6x10 clamshell; UPC: 850021494766 / 2. Greens Gaia Organic 5050; 6x10 clamshell; UPC: 850021494827 / 3. Greens Gaia Organic 50/50 blend; 8x45 clamshell; UPC: 850021494919 / 4. Greens Gaia Organic 50/50; 8x45 clamshell; UPC: 850021494957 / 5. Greens Full Ci
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0604-2024·2024-07-24

    Potassium Chloride Extended-Release Capsules Recalled for Failed Dissolution Specifications

    Glenmark Pharmaceuticals is recalling potassium chloride extended-release capsules (750 mg) nationwide due to failed dissolution specifications. Affected patients should contact their healthcare provider before making any changes to their medication.

    Product
    POTASSIUM CHLORIDE — POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1485-2024·2024-07-24

    Terrafina raw macadamia nuts recalled for salmonella contamination

    Terrafina macadamia nuts are being recalled because they tested positive for salmonella. The product was distributed in New Jersey and New York.

    Product
    Terrafina, Macadamia in the Raw , Net Wt. 6oz , (170 g)
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1481-2024·2024-07-24

    Spring Mix Herb Products Recalled for Potential Listeria monocytogenes Contamination

    Solata Food LLC is recalling three brands of spring mix herb products sold in NY, NJ, and NH due to potential contamination with Listeria monocytogenes, a bacterium that can cause serious illness.

    Product
    1. Greens Gaia Organic Spring Mix Herb; 8x45 clamshell; UPC: 850021494896 / 2. Greens Solata Spring Mix Herb; 8x5 clamshell; UPC: 854311007063 / 3. Greens Uncle Vinny's Spring Mix Herb; 8x5 clamshell; UPC: 804879459965
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0609-2024·2024-07-24

    StellaLife VEGA Oral Care Spray Recalled for Bacillus Contamination

    StellaLife VEGA Oral Care spray bottles have been recalled due to contamination with multiple Bacillus species organisms. The FDA Class I recall affects 31,811 bottles distributed nationwide to physician offices.

    Product
    STELLALIFE VEGA ORAL CARE — STELLALIFE VEGA ORAL CARE (ARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, RUTA, STAPHYSAGRIA)
    Category
    Drug
    Distribution
    Distributed nationwide