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.

14101–14125 of 27263

  • SevereFDA (Food)·F-0445-2024·2023-11-22

    Frozen ice cream product recalled due to undeclared allergens

    Paradise Flavors LLC recalled Ferrero Rocher ice-cream base distributed in Florida due to undeclared allergens: milk, tree nuts, peanuts, soy, and wheat. Consumers should not consume this product if allergic to these substances.

    Product
    Ferrero Rocher, Ice-cream base, Hazelnut, Nutella, Penuts, Cacao, Rich Chocolate, Artificial flavoring., DISTRIBUTED BY: PARADISE FLAVORS LLC. 4oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0439-2024·2023-11-22

    Paradise Flavors Rice Pudding Ice Cream Mix Recalled for Undeclared Milk

    Paradise Flavors Arroz con Leche rice pudding ice cream mix is recalled due to undeclared milk allergen. Consumers with milk allergies should not consume this product.

    Product
    ARROZ CON LECHE/RICE PUDDING, Ice cream MIX, Filtered water, Natural Rice, cinamon and caramel, DISTRIBUTOR PARADISE FLAVORS LLC, 4 oz. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0447-2024·2023-11-22

    Pine Nut Ice Cream Bar Recalled for Undeclared Milk, Soy, Wheat, Tree Nuts

    Paradise Flavors LLC has recalled its 4 oz Pine Nut Ice Cream Bar due to undeclared allergens: milk, tree nuts, soy, and wheat. The product was distributed in Florida and poses a risk to consumers with these allergies.

    Product
    Pine Nut/Pinon, Ice Cream Bar, Ice cream base, natural flavoring, dehydrated fruit, artificial coloring, 4 oz, Paradise Flavors. Packaged in plastic pouch. Frozen.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0419-2024·2023-11-22

    Amazon Fresh Frosted Mini Brownies recalled for potential plastic contamination

    Amazon Fresh Frosted Mini Brownies (Item 19858) may contain plastic pieces. The 12-count packs distributed nationwide are subject to recall.

    Product
    Item 19858, Amazon Fresh, Frosted Mini Brownie with yellow and purple icing with sprinkles, 12 count per pack, packaged in a plastic clear clamshell container, net wt. 14oz. Case UPC 1 08 42379 19858 5; Retail package UPC 8 42379 19858 8.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0313-2024·2023-11-22

    Blood Culture Kits Recalled Due to Expired Internal Components

    Medline Industries is recalling 3,160 units of 24 Blood Culture Kits because components within the kit have expired before the overall kit's stated expiration date. Expired components may compromise device performance or test result accuracy.

    Product
    24 BLOOD CULTURE KIT, REF DYNDH1632
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0317-2024·2023-11-22

    Oasis Water Seal Chest Drains Recalled for Inadequate Setup Instructions

    Atrium Medical's Oasis Dry Suction Water Seal Chest Drains are recalled because Instructions for Use do not adequately explain proper setup of catheter and patient tube connections on single collection chamber models.

    Product
    Oasis Dry Suction Water Seal Chest Drains (Oasis): (1)3600-100 DRAIN, OASIS SINGLE W/AC; (2)3612-100 DRAIN, OASIS PEDI A/C; (3)3650-100 DRAIN, OASIS BRU W/AC;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0302-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recalled for Loose Battery Pins Causing Power Loss

    Physio-Control is recalling LIFEPAK 15 defibrillators due to a potential for battery pins to become loose, which could cause power failure.

    Product
    LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0314-2024·2023-11-22

    Blood culture kit recalled due to expired internal components

    Medline's blood culture kit is being recalled because components inside the kit have expired before the kit's stated expiration date. This could affect the kit's ability to function properly.

    Product
    BLOOD CULTURE KIT, REF DYNDH1647B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0105-2024·2023-11-22

    Equate Hand Sanitizer recalled for potency non-compliance in Puerto Rico

    Equate Hand Sanitizer 7.5 oz bottles (Lot #006511) from Omega & Delta Co., Inc. are being recalled due to potency non-compliance. The product was distributed in Puerto Rico.

    Product
    Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-0303-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Loss

    Physio-Control is recalling 8 LIFEPAK 15 defibrillators due to loose battery pins that may cause power loss. Affected units were distributed in Arizona, California, North Carolina, New Jersey, and New York.

    Product
    LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0304-2024·2023-11-22

    LIFEPAK 15 Defibrillators Recalled Due to Potential Loose Battery Pins

    Physio-Control has recalled LIFEPAK 15 defibrillators because battery pins may become loose, causing power issues. Owners should contact the manufacturer for instructions on how to proceed.

    Product
    LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0414-2024·2023-11-22

    Full Spectrum Hemp Oil Gummies recalled for undeclared sunflower allergen

    Tay's Sales and Distribution is recalling Full Spectrum Cold Pressed Hemp Oil Gummies due to undeclared sunflower allergen in the product. Affected products (Lot 081321) were distributed in Iowa and Illinois.

    Product
    Full Spectrum Cold Pressed Hemp Oil Gummies, Fruit Punch, 1.41 oz (4-count) and 8oz (15-count).
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0307-2024·2023-11-22

    Medical Device Recall: KWIKSTIK Microbiological Reagent Contaminated with Aspergillus

    Microbiologics Inc recalls KWIKSTIK microbiological reagent kits due to Aspergillus flavus contamination in bulk pellets. Affected products were distributed worldwide, including the US, Italy, France, Turkey, Peru, and Mexico.

    Product
    KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0294-2024·2023-11-22

    CT Scanner Image Fusion Software Error Affecting Radiation Therapy Planning

    A software bug in Philips Brilliance CT scanners causes image-fusion errors, resulting in incorrect radiation therapy coordinates and potential treatment planning failures.

    Product
    Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0416-2024·2023-11-22

    Hemp Oil Gummies Recalled for Undeclared Sunflower Butter Sub-Ingredients

    Tay's Sales and Distribution is recalling Full Spectrum Cold Pressed Hemp Oil Gummies because the sub-ingredients of sunflower butter were not declared on the label. The affected packages were distributed in Iowa and Illinois.

    Product
    Full Spectrum Cold Pressed Hemp Oil Gummies, Peach, 1.41 oz (4-count) and 8oz (15-count).
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0417-2024·2023-11-22

    Hemp Oil Gummies Recalled Due to Undeclared Sunflower Butter Allergen

    Tay's Sales and Distribution is recalling Full Spectrum Cold Pressed Hemp Oil Gummies because sunflower butter sub-ingredients were not declared on the label. Consumers with sunflower allergies may experience allergic reactions.

    Product
    Full Spectrum Cold Pressed Hemp Oil Gummies, Pomegranate, 1.41 oz (4-count) and 8oz (15-count).
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0292-2024·2023-11-22

    Philips Big Bore RT CT Scanner Defect May Cause Incorrect Treatment Planning

    A software defect in Philips Big Bore RT CT scanners may cause incorrect coordinates in radiation therapy planning systems, affecting 56 units distributed nationwide and internationally.

    Product
    Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0297-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Loss

    Physio-Control is recalling LIFEPAK 15 defibrillators due to potential loose battery pins that could result in power loss. Affected devices were distributed in AZ, CA, NC, NJ, and NY.

    Product
    LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0106-2024·2023-11-22

    Compressed Oxygen Cylinders Recalled Due to Manufacturing Quality Deviations

    Family Medical Supply Inc is recalling 26,657 cylinders of compressed oxygen distributed nationwide due to manufacturing practice deviations. Cylinders were manufactured between May 10 and October 31, 2023.

    Product
    Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family Medical Supply, 2011 W Cumberland St. Dunn, NC 28334.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0418-2024·2023-11-22

    Hemp Oil Gummies Recalled for Undeclared Sunflower Butter Sub-ingredients

    Tay's Sales and Distribution is recalling Full Spectrum Cold Pressed Hemp Oil Gummies, Fennel in 1.41 oz and 8 oz packages due to undeclared sub-ingredients in the sunflower butter component. Consumers should not consume the affected product.

    Product
    Full Spectrum Cold Pressed Hemp Oil Gummies, Fennel, 1.41 oz (4-count) and 8oz (15-count).
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0293-2024·2023-11-22

    Philips Brilliance CT Big Bore May Send Incorrect Coordinates During Radiation Therapy Planning

    Philips Brilliance CT Big Bore units with software V4.8.0.10421 may produce inaccurate image position data when offset reconstruction is used. This could lead to incorrect radiation therapy planning or diagnosis.

    Product
    Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0316-2024·2023-11-22

    Ocean Chest Drains Recalled for Inadequate Assembly Instructions

    Atrium Medical recalls Ocean chest drains due to insufficient precaution instructions for proper catheter and tube connection setup. Improper assembly could compromise device function.

    Product
    Ocean Water Seal Chest Drains (Ocean): Products REF Number Product Name (1)2002-000 DRAIN, OCEAN SINGLE W/AC,S; (2)2002-040 DRAIN, OCEAN SINGLE,PEDI CONNECTOR; (3)2002-100 DRAIN, OCEAN SINGLE W/AC; (4)2002-300 DRAIN, OCEAN SINGLE W/S; (5) 2002-400 DRAIN, OCEAN SINGLE ;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0296-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall for Battery Pin Loosening

    Physio-Control, Inc. is recalling LIFEPAK 15 defibrillators (Part Number V15-2-000051) because battery pins may loosen and cause power failure. Affected devices should not be used until repaired.

    Product
    LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0299-2024·2023-11-22

    LIFEPAK 15 defibrillator recalled for potential battery power loss

    Physio-Control is recalling 5 LIFEPAK 15 defibrillators due to a potential defect where battery pins may become loose, resulting in power loss. No illnesses or injuries have been reported.

    Product
    LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0308-2024·2023-11-22

    Laboratory Culture Disks Recalled for Aspergillus Flavus Contamination

    Microbiologics Inc is recalling LYFO-DISK P. venetum laboratory culture disks (lot 794-142) found contaminated with Aspergillus flavus during complaint investigation. The product was distributed worldwide.

    Product
    LYFO-DISK, P. venetum, Catalog number 0794L
    Category
    Medical Device
    Distribution
    Distributed nationwide