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.

16701–16725 of 88183

  • LowFDA (Devices)·Z-2591-2023·2023-09-27

    Arrow ErgoPack PICC catheter kits recalled for incorrect product labeling

    Arrow International recalled 177 ErgoPack PICC catheter kits because the product code and name were incorrectly listed on the packaging. No illnesses or injuries reported.

    Product
    Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2509-2023·2023-09-20

    Abbott Proclaim DRG Implantable Pulse Generators cannot exit MRI mode

    Abbott Medical is recalling approximately 17,394 Proclaim DRG Implantable Pulse Generators worldwide due to reports that patients cannot exit MRI mode on affected devices. This malfunction may prevent normal device operation when mode-switching is needed.

    Product
    Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2510-2023·2023-09-20

    Abbott Infinity 5 Implantable Pulse Generator Patients Unable to Exit MRI Mode

    Some Abbott Infinity 5 implantable pulse generator patients report being unable to exit MRI mode on their devices. This Class I recall affects 5,932 devices distributed globally.

    Product
    Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2514-2023·2023-09-20

    FDA Recalls Medline Hudson RCI Addipak Inhalation Solution for Sterility Failure

    Medline Industries is recalling HUDSON RCI Addipak 5mL sterile saline inhalation solution due to sterility failure. Approximately 18,000 units were distributed nationwide; the product was intended for scrap but was inadvertently shipped to customers.

    Product
    HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1494-2023·2023-09-20

    Zespri Organic Green Kiwi recalled for Listeria monocytogenes contamination

    Zespri Organic Green Kiwi from New Zealand is being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed across 14 states.

    Product
    Zespri Organic Green Kiwi, product of New Zealand, perishable, packaged in plastic clamshell, net wt. 1lb. UPC 818849020093. Distributed by The Oppenheimer Group, 180 Nickerson Street, Suite 211 Seattle WA. Zespri Organic Green Kiwi, product of New Zealand, perishable, packaged…
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Devices)·Z-2506-2023·2023-09-20

    Proclaim XR 7 Implantable Pulse Generators unable to exit MRI mode

    Abbott Medical is recalling Proclaim XR 7 Implantable Pulse Generators due to a malfunction that prevents patients from exiting MRI (Magnetic Resonance Imaging) mode, potentially disrupting normal device operation and therapy delivery.

    Product
    Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2508-2023·2023-09-20

    Proclaim Plus 7 Implantable Pulse Generator Cannot Exit MRI Mode

    Abbott Medical recalled Proclaim Plus 7 Implantable Pulse Generators due to a defect preventing patients from exiting MRI mode. This operational failure could compromise device functionality during or after magnetic resonance imaging procedures.

    Product
    Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1495-2023·2023-09-20

    Zespri Organic Green Kiwi Recalled Due to Listeria Contamination

    Zespri Organic Green Kiwi from New Zealand has been recalled due to potential Listeria monocytogenes contamination. The recalled pallet was distributed across 14 U.S. states.

    Product
    Zespri Organic Green Kiwi, product of New Zealand, one pallet of bulk loose organic green kiwifruit was shipped to one consignee in Chicago, IL. The master carton has the barcode 067834 and the kiwi PLU label has the code GTIN 9400 9552.
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Food)·F-1513-2023·2023-09-20

    Natural Products Supplement Recalled Due to Mislabeling with Toxic Plant

    Todorganic Inc. is recalling TODRGANIC Natural Products NUEZ DE LA INDIA (Lot 168, EXP 10/24) because the product contains Yellow Oleander instead of the labeled ingredient. Yellow Oleander is toxic if ingested.

    Product
    TODRGANIC Natural Products, NUEZ DE LA INDIA, Natural Products, 12 Seeds 12 Semillas
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2450-2023·2023-09-20

    Mallinckrodt One-Way Valve Recalled Due to Potential Oxygen Flow Failure

    Mallinckrodt Manufacturing is recalling approximately 13,600 One-Way Valves used with ventilators due to risk of valve sticking and oxygen flow reduction. The Class I recall affects worldwide distribution.

    Product
    Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #50412 (pack of 5) Used with ventilators.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2511-2023·2023-09-20

    Infinity 7 Implantable Pulse Generator Recall Due to MRI Mode Exit Failure

    Abbott Medical recalls Infinity 7 Implantable Pulse Generators due to reports that patients cannot exit MRI mode. The FDA has classified this as a Class I recall affecting devices distributed worldwide.

    Product
    Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2507-2023·2023-09-20

    Abbott Proclaim Plus 5 Implantable Pulse Generator MRI Mode Exit Failure

    Abbott Medical is recalling Proclaim Plus 5 Implantable Pulse Generators (Model 3670) due to reports that patients are unable to exit MRI mode on the devices.

    Product
    Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1180-2023·2023-09-20

    WEFUN Capsules Recalled: Unapproved Drug with Undisclosed Sildenafil

    WEFUN Capsules 825 mg are being recalled due to contamination with sildenafil, an undisclosed active pharmaceutical ingredient not approved for the product. Distribution was nationwide.

    Product
    WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2505-2023·2023-09-20

    Proclaim XR 5 Implantable Pulse Generators Cannot Exit MRI Mode

    Abbott Medical recalled the Proclaim XR 5 Implantable Pulse Generator after patients reported being unable to exit MRI mode on their devices. Approximately 113,784 units were distributed worldwide.

    Product
    Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1522-2023·2023-09-20

    Texas Tamale Company Black Bean Tamales Recalled for Undeclared Milk

    Texas Tamale Company is recalling Black Bean Tamales due to undeclared milk. The product poses a risk to consumers with milk allergies.

    Product
    Texas Tamale Black Bean Tamales 18 oz, (1 lb. 2 oz), 510 g
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1501-2023·2023-09-20

    Cream Cheese Rangoon Recalled Due to Plastic Foreign Object

    Pegasus Foods, Inc. is recalling Cream Cheese Rangoon due to the presence of plastic foreign objects in the product. Approximately 38,887 cases distributed in California are affected.

    Product
    Cream Cheese Rangoon NET WT: 5.00 LB. (2.26 KG) CT/CS: 100 PS (5 TRAYS X 20 PCS UPC: (01)10664383187016(15)112823(10)0601233A1W package in corrugated cardboard case.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2571-2023·2023-09-20

    Landauer nanoDot dosimeters recalled for potential accuracy deviation

    Landauer has recalled nanoDot radiation dosimeters due to potential accuracy deviations in the Optical Stimulated Luminescence material used to measure radiation exposure. Affected units may read outside the specified +/-5.5% accuracy range.

    Product
    Constancy (80 kVp) nanoDot D2DNN, Model Numbers: a) 18150-000 (EMEA number VKITCON002); b) 18150-KIT; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-1148-2023·2023-09-20

    Pantoprazole Sodium for Injection Recalled Due to Sterility Concern

    BE Pharmaceuticals is recalling Pantoprazole Sodium for Injection nationwide due to lack of sterility assurance caused by powder discoloration and small cracks in some vials. No illnesses have been reported.

    Product
    PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2574-2023·2023-09-20

    NanoDots radiation dosimeter recalled for potential measurement accuracy issues

    Landauer is recalling NanoDots radiation monitoring dosimeters because some units may not meet specified accuracy of +/-5.5% due to a defect in the luminescence material.

    Product
    NanoDots, Model Number 04297-000; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1512-2023·2023-09-20

    US Foods Peanut Butter Toffee Bar recalled for possible plastic contamination

    Killer Brownie Ltd is recalling US Foods Peanut Butter Toffee Bars (3.4oz) distributed in Illinois due to possible plastic foreign material. Consumers should not eat affected units.

    Product
    US Foods: Peanut Butter Toffee Bar, 3.4oz unit size, packaged in flow wrap, 24 packages per case
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2553-2023·2023-09-20

    Radiation Dosimeter Kit Recalled Due to Potential Accuracy Drift

    Landauer is recalling nanoDot radiation dosimeter kits (16,760 units distributed worldwide) because some units may measure radiation exposure outside specified accuracy tolerances, potentially affecting dose measurement accuracy.

    Product
    nanoDot kit (contains nanoDot A, B, C), Model Number 03500-000; radiation monitoring dosimeter used with the microSTAR readers
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2587-2023·2023-09-20

    Philips X-Ray Systems Recalled for Foot Switch Malfunction Risk

    Philips Allura and Azurion x-ray imaging systems are being recalled due to a damaged foot switch component that may prevent or intermittently disable x-ray radiation initiation. Approximately 19,115 systems are affected worldwide.

    Product
    Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and MultiDiagnost-Eleva systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1516-2023·2023-09-20

    Knorr Alphabet Pasta Soup Recalled for Undeclared Egg Allergen

    Knorr Letras con Tomate soup mix is being recalled because it contains undeclared egg. Consumers with egg allergies should not consume this product.

    Product
    Knorr Letras con Tomate Tomato Based Alphabet Pasta Soup Mix 3.5 oz UPC: 048001716186
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2582-2023·2023-09-20

    ACUSON Redwood 2.0 Ultrasound Systems Display Incorrect Measurement Results

    ACUSON Redwood 2.0 ultrasound systems may display underestimated measurement results when using an 18L6 transducer in Dual format, potentially leading to patient misdiagnosis. 796 units are affected worldwide.

    Product
    ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
    Category
    Medical Device
    Distribution
    Distributed nationwide