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.

6051–6075 of 88183

  • HighFDA (Food)·H-0639-2025·2025-10-08

    Frozen cooked shrimp bags recalled over possible cesium 137 contamination

    Kroger is recalling 4,871 cases of frozen cooked tail-on shrimp made under insanitary conditions in which the product may have been contaminated with Cesium-137.

    Product
    16/25 Frozen Cooked Tail-On Farm Raised Shrimp; 12oz clear plastic retail bag. UPC: 011110649812 51/60 Frozen Cooked Tail-On Farm Raised Shrimp; 32oz clear plastic retail bag. UPC: 011110967015
    Category
    Food
    Distribution
    16 states
  • HighFDA (Food)·H-0001-2026·2025-10-08

    Sourdough batard bread recalled because it may contain undeclared sesame seeds

    Oven Artisans is recalling four pallets of Orwashers Soho Sourdough XL Batard because the product was mislabeled and may contain undeclared sesame seeds.

    Product
    Orwashers brand Soho Sourdough XL Batard; contains: wheat; 6-46.4oz PIECES PER CASE
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0021-2026·2025-10-08

    Reprocessed 2.0mm over the wire atherectomy catheters recalled for packaging breaches

    Northeast Scientific is recalling 199 reprocessed 2.0mm OTW Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-006. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0037-2026·2025-10-08

    Vitamin B12 gummies recalled for undeclared peanuts under two brand names

    9,657 bottles of raspberry flavored vitamin B12 gummies sold as Black Girl Vitamins and Rise-N-Shine are being recalled because the product may contain undeclared peanuts.

    Product
    vitamins B12 dietary supplement Raspberry Flavored sold under the following brand names: 1. Black Girl Vitamins 60 gummies UPC 8 60008 57505 0 Manufactured for: Black Girl Vitamins 601 W Harrison St., Chicago, IL 60607. 2. Rise-N-Shine 17 Woodport Road, Sparta, NJ 07871…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0023-2026·2025-10-08

    Reprocessed 1.4mm rapid exchange atherectomy catheters recalled for packaging breaches

    Northeast Scientific is recalling 1,019 reprocessed 1.4mm RX Turbo Elite laser atherectomy catheters because of potential breaches in the sterile barrier packaging.

    Product
    NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-159. The NES Reprocessed Turbo-Elite Laser Atherectomy Catheter is indicated for use in the treatment, including atherectomy, of infrainguinal stenoses and occlusions. This model is not…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0036-2026·2025-10-08

    Vascular grafts recalled after delamination reports prompt instructions for use update

    W. L. Gore is recalling 52,306 GORE ACUSEAL Vascular Grafts following reports of graft delamination, and is updating the instructions for use with expanded warnings.

    Product
    GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.
    Category
    Medical Device
    Distribution
    51 states
  • ModerateFDA (Devices)·Z-0002-2026·2025-10-08

    Allura Xper FD10 X-ray systems recalled over premature BIOS battery depletion

    Philips is recalling 2,317 Allura Xper FD10 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up with no warning.

    Product
    Allura Xper FD10; Model Numbers: (1) 722003, (2) 722010, (3) 722026; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·H-0008-2026·2025-10-08

    Raspberry peach jam cookies recalled for undeclared Red 3 and Blue 1

    Vanilla Cookies with Raspberry Peach Jam are being recalled because the colour additives Red 3 and Blue 1 are not declared on the label. The recall covers 172 cases.

    Product
    Vanilla Cookies with Raspberry Peach Jam
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0011-2026·2025-10-08

    Allura Xper FD20/15 OR Table systems recalled over BIOS battery depletion

    Philips is recalling eight Allura Xper FD20/15 OR Table systems because the BIOS battery may deplete faster than designed, halting start-up without warning.

    Product
    Allura Xper FD20/15 OR Table; Model Numbers: 722059; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0009-2026·2025-10-08

    Allura Xper FD20/10 X-ray systems recalled for BIOS battery startup failure

    Philips is recalling 87 Allura Xper FD20/10 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.

    Product
    Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0004-2026·2025-10-08

    Allura Xper FD10 OR Table systems recalled over BIOS battery depletion

    Philips is recalling two Allura Xper FD10 OR Table systems because the BIOS battery may deplete faster than designed, stopping the system from starting.

    Product
    Allura Xper FD10 OR Table; Model Numbers: 722033; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0012-2026·2025-10-08

    Allura Xper FD20/20 X-ray systems recalled for BIOS battery startup failure

    Philips is recalling 115 Allura Xper FD20/20 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.

    Product
    Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0003-2026·2025-10-08

    Allura Xper FD10/10 X-ray systems recalled for BIOS battery startup failure

    Philips is recalling 585 Allura Xper FD10/10 interventional X-ray systems because the BIOS battery may deplete faster than designed, stopping the system from starting.

    Product
    Allura Xper FD10/10; Model Numbers: (1) 722005, (2) 722011, (3) 722027; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0005-2026·2025-10-08

    Allura Xper FD20 X-ray systems recalled over premature BIOS battery depletion

    Philips is recalling 5,067 Allura Xper FD20 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up with no warning.

    Product
    Allura Xper FD20; Model Numbers: (1) 722006, (2) 722012, (3) 722028; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0013-2026·2025-10-08

    Allura Xper FD20/20 OR Table systems recalled over BIOS battery depletion

    Philips is recalling five Allura Xper FD20/20 OR Table systems because the BIOS battery may deplete faster than designed, halting start-up.

    Product
    Allura Xper FD20/20 OR Table; Model Numbers: 722039; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0010-2026·2025-10-08

    Allura Xper FD20/15 X-ray systems recalled over premature BIOS battery depletion

    Philips is recalling 300 Allura Xper FD20/15 interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.

    Product
    Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0006-2026·2025-10-08

    Allura Xper FD20 Biplane systems recalled over premature BIOS battery depletion

    Philips is recalling 501 Allura Xper FD20 Biplane interventional X-ray systems because the BIOS battery may deplete faster than designed, halting start-up.

    Product
    Allura Xper FD20 Biplane; Model Numbers: (1) 722008, (2) 722013; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0008-2026·2025-10-08

    Allura Xper FD20 OR Table systems recalled over BIOS battery depletion

    Philips is recalling 298 Allura Xper FD20 OR Table systems because the BIOS battery may deplete faster than designed, halting start-up.

    Product
    Allura Xper FD20 OR Table; Model Numbers: (1) 722015, (2) 722023, (3) 722035; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;
    Category
    Medical Device
    Distribution
    Distributed nationwide