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.

6126–6150 of 88183

  • HighFDA (Devices)·Z-2594-2025·2025-10-01

    Intravenous solution sets recalled after customer reports of tubing separation

    Baxter is issuing an urgent recall for one lot of Continu-Flo Solution Sets, REF 2C8519, after customer reports of tubing separation. 14,400 units are affected.

    Product
    Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0665-2025·2025-10-01

    Benzaderm BPO cleanser recalled over elevated benzene in benzoyl peroxide

    Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10%, 7 oz, lots 58170A and 58172A, is recalled because of elevated levels of benzene.

    Product
    Torrey Pines Dermatology & Laser Center Benzaderm BPO Cleanser 10% (Benzoyl Peroxide 10%) 7oz (201 g), Torreypines.com
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2626-2025·2025-10-01

    Allura Xper FD20 systems recalled over component deterioration halting motorized movements

    Philips Allura Xper FD20 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 2,114 units are affected.

    Product
    Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0668-2025·2025-10-01

    Benzoyl peroxide cleanser recalled after elevated benzene levels were found

    edunn clarity BP Treatment Cleanser 10%, 7 oz, lots 58170A and 58172A, is recalled because of elevated levels of benzene. The product was distributed in California and Georgia.

    Product
    edunn clarity, BP Treatment Cleanser 10% (Benzoyl Peroxide 10%), 7 oz (201g) Uptown Medi Spa, Phoenix, AZ.
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2597-2025·2025-10-01

    Big Bore CT systems recalled because patient table may descend unexpectedly

    Philips Big Bore RT, Brilliance CT Big Bore Oncology and Brilliance CT Big Bore systems are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 33 units are affected.

    Product
    Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0663-2025·2025-10-01

    Artisan of Skin acne treatment recalled over elevated benzene levels

    Artisan of Skin Benzoyl Peroxide 10%, 7 oz, lots 58170A and 58172A, is recalled because of elevated levels of benzene. 125 units distributed in California and Georgia are affected.

    Product
    ARTISAN OF SKIN (Benzoyl Peroxide 10%) , 7 oz (201 g), Artisan of Skin Beverly Hills, CA 90210
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-2629-2025·2025-10-01

    Allura Xper FD20 Biplane OR Table recalled over internal component deterioration

    Philips Allura Xper FD20 Biplane OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 5 units are affected.

    Product
    Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0621-2025·2025-10-01

    CBD and THC gummies recalled over potential peanut protein cross-contact

    Extract Labs Sugar-free Mixed Berry Gummies, lot 25E5082907A, are recalled because of potential peanut protein cross-contact. 2,180 gummies in 109 bottles are affected.

    Product
    Sugar-free Mixed Berry Gummies Brand Name: Extract Labs Generic Name: Dietary Supplement Strength: 10mg CBD and 10mg D9 THC per gummy Dosage: 1 gummy Form: Gummy Administration: Oral Intended use: Dietary Supplement Type of packaging: 225cc amber packer bottle with…
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2604-2025·2025-10-01

    CT 6000 scanners recalled because the patient table may drop unexpectedly

    Philips CT 6000 systems, model 728307, are recalled because the patient support table may descend unexpectedly due to ball screw misalignment after a replacement. 6 units are affected.

    Product
    Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2598-2025·2025-10-01

    Brilliance iCT systems recalled over ball screw misalignment dropping the couch

    Philips Brilliance iCT systems, model 728306, are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 210 units are affected.

    Product
    Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2636-2025·2025-10-01

    Vessel harvesting systems recalled after out-of-box failures in harvesting tool jaws

    Vasoview Hemopro 3 Endoscopic Vessel Harvesting Systems are recalled after out-of-box failures including deformed jaw attachments, jaws not fully closed and lifted heater wire. 98 units are affected.

    Product
    Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOVIEW HEMOPRO 3 Endoscopic Vessel Harvesting (EVH) System (VH-6000, VH-6001, and VH-6010) is a vessel harvesting kit designed for use with a 7 mm endoscope to cut and cauterize vessel branches.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2595-2025·2025-10-01

    Brilliance CT 40 and 64 channel systems recalled over unexpected couch descent

    Philips Brilliance CT 40 Channel, Brilliance CT 64 Channel and Ingenuity Flex systems are recalled because the patient support table may descend unexpectedly after a ball screw replacement. 181 units are affected.

    Product
    Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2635-2025·2025-10-01

    Allura CV20 systems recalled over internal component deterioration disabling motorized movement

    Philips Allura CV20 systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 46 units are affected.

    Product
    Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2634-2025·2025-10-01

    Allura Xper FD20/15 OR Table recalled over internal component deterioration

    The Philips Allura Xper FD20/15 OR Table is recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. One unit is affected.

    Product
    Allura Xper FD20/15 OR Table; Product Code: 722059; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2628-2025·2025-10-01

    Allura Xper FD20 OR Table recalled over CMOS battery and drive deterioration

    Philips Allura Xper FD20 OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 174 units are affected.

    Product
    Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2622-2025·2025-10-01

    Patient monitors recalled over potential activation of an abnormal alarm pause

    BeneVision N1 Patient Monitors are recalled because of the potential for activation of an abnormal alarm pause. 2,278 units are affected.

    Product
    BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q6660E-PA00018, 6660E-PA00010, Q6660E-PA00010, Q6660E-PA00021…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2625-2025·2025-10-01

    Allura Xper FD10 OR Table recalled over ageing power supply and drive

    Philips Allura Xper FD10 OR Table systems are recalled because deterioration of the CMOS battery, hard disk drive and/or power supply may make motorized movements unavailable. 2 units are affected.

    Product
    Allura Xper FD10 OR Table Product Codes: (1)722022, (2) 722033; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0660-2025·2025-10-01

    Isopropyl alcohol cans recalled for cross contamination with other products

    Kroger is recalling 1,860 bottles of its 70% Isopropyl Alcohol, 5.5 oz, from a single lot because of cross contamination with other products.

    Product
    70% ISOPROPYL RUBBING ALCOHOL — 70% ISOPROPYL RUBBING ALCOHOL (ISOPROPYL RUBBING ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0659-2025·2025-10-01

    Alcohol prep pads recalled over current good manufacturing practice deviations

    Quick Touch Alcohol Prep Pads containing 70% isopropyl alcohol, lot 20240610, are recalled for current good manufacturing practice deviations. 500 cases are affected.

    Product
    Quick Touch Alcohol Prep Pads(Isopropyl Alcohol 70%), 100 Sterile Pads per carton, AUM Pharmaceuticals, 320 Oser Ave., Hauppauge, NY 11788.
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0662-2025·2025-10-01

    Azelaic acid gel recalled after complaints of gritty texture in tubes

    Glenmark Azelaic Acid Gel, 15%, 50 gram tubes from batch 19252524, is recalled nationwide after market complaints of a gritty or grainy texture. 13,824 tubes are affected.

    Product
    AZELAIC ACID — AZELAIC ACID (AZELAIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0661-2025·2025-10-01

    Isopropyl alcohol cans recalled over cross contamination with other products

    TopCare Health 70% Isopropyl Alcohol, 5.5 oz cans, lot 0662036, distributed by Kroger, is recalled for cross contamination with other products. 60 units are affected.

    Product
    70% ISOPROPYL RUBBING ALCOHOL — 70% ISOPROPYL RUBBING ALCOHOL (ISOPROPYL RUBBING ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0672-2025·2025-10-01

    Amphetamine extended-release capsules 20 mg recalled over impurity and degradation results

    Mixed amphetamine salts extended-release capsules, 20 mg, lot GPC250179A, are recalled nationwide after failing impurities and degradation specifications. 11,909 bottles are affected.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2633-2025·2025-10-01

    Allura Xper FD20/15 X-ray System Motorized Movement Component Deterioration

    Philips recalls Allura Xper FD20/15 X-ray systems due to potential deterioration of internal components that may disable motorized movements, though manual movements and imaging functionality remain available.

    Product
    Allura Xper FD20/15; Product Code: 722058; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2618-2025·2025-10-01

    Extractor Pro RX Retrieval Balloon Catheter incorrectly labeled

    Boston Scientific Corporation is recalling Extractor Pro RX Retrieval Balloon Catheters because the label incorrectly indicates the position of the skive hole relative to the balloon.

    Product
    Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
    Category
    Medical Device
    Distribution
    Distributed nationwide