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.

14951–14975 of 27263

  • ModerateFDA (Devices)·Z-2622-2023·2023-09-27

    COOLIEF RF Generator recalls due to F100 and F101 fault complaints

    Avanos Medical is recalling 24 COOLIEF RF Generator units that have produced F100 and F101 faults. Units were distributed to 17 U.S. states and Brazil.

    Product
    COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a touch screen interface display that includes user controls, alarm messages, and
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Food)·F-1530-2023·2023-09-27

    HEB Easy Melt Pasteurized Cheese Spread Recalled for Conflicting Refrigeration Labels

    Great Lakes Cheese is recalling HEB Easy Melt Original Pasteurized Process Cheese Spread because refrigeration instructions vary across product labels. No illnesses have been reported.

    Product
    Pasteurized Process Cheese Spread packaged under the following brands and sizes: 1. HEB Easy Melt Original, Net Wt 16 oz (1 lb) 453g. UPC 0 41220-73808 3. Refrigerate after Opening. Made with Pride and Care for H-E-B, San Antonio, Texas 78204 2. HEB Easy Melt Original, Net
    Category
    Food
    Distribution
    32 states
  • ModerateFDA (Drugs)·D-1173-2023·2023-09-27

    Kroger Mint Burst Antiseptic Mouth Rinse recalled for undeclared excipients

    Vi-Jon, LLC is recalling 245,904 bottles of Kroger Mint Burst Antiseptic Mouth Rinse due to incorrect or undeclared excipients. The product was distributed through a single distributor with seven distribution centers.

    Product
    Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGINGIVITIS/ANTIPLAQUE (Eucalyptol 0.092%, menthol 0.042%, Methyl salicylate 0.06%, thymol 0.064%), packaged in 16.9 FL OZ (500 mL) bottle, DISTRIBUTED BY THEKROGER CO. CINCINNATI, OHIO 45202, UPC 011110380807
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2609-2023·2023-09-27

    Chemistry Quality Control Material Recalled for Transcription Error in Instructions

    Randox Laboratories recalled Liquid Assayed Chemistry Control Premium Plus Level 3 due to incorrect standard deviation values in the product instructions. The error could affect patient result reporting, but the correct operating values remain available.

    Product
    Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2613-2023·2023-09-27

    Prucka 3 Amplifier Power Supply May Fail and Cause Device Inoperability

    GE Medical Systems is recalling Prucka 3 Amplifiers and related field replaceable units used in CardioLab and ComboLab systems. A power supply diode may overheat and fail, causing the amplifier to stop working.

    Product
    Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model 5875569, used with CardioLab AltiX and ComboLab AltiX.
    Category
    Medical Device
    Distribution
    17 states
  • ModerateFDA (Food)·F-1539-2023·2023-09-27

    Fox Confections Recalls Raspberry Truffles for Undeclared Food Dyes

    Fox Confections is recalling F-Bombs Raspberry Truffles because they contain undeclared FD&C Yellow #5 and Yellow #6. The product was distributed to 90 retail locations in Illinois and Ohio.

    Product
    F-Bombs Raspberry Truffles: 12 ounce plastic packaging, plastic packaging is packed into 4x4x2 cardboard boxes. UPC 850036018124
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-1523-2023·2023-09-27

    Cheese Spread Products Recalled for Inconsistent Refrigeration Requirements

    Multiple cheese spread brands are being recalled due to inconsistent refrigeration instructions on labels. Consumers should verify proper storage and discard products with unclear label instructions.

    Product
    Cheese Spread Pasteurized Process packaged under the following brands and sizes: 1. bowl & Basket, A Shoprite Brand, Net Wt 32 oz (2lb)907g. UPC 0 41190-46935 2. Refrigerate after Opening. Distributed by: Wakeforn Food Corp, 5000 Riverside Drive, Keasbey, NJ 08832 2. Luce
    Category
    Food
    Distribution
    32 states
  • ModerateFDA (Food)·F-1529-2023·2023-09-27

    Harris Teeter Cheesy Melt recalled for labeling refrigeration requirements

    Harris Teeter Cheesy Melt pasteurized cheese product is recalled because labeling variations may prevent proper refrigeration. Approximately 7.2 million pounds are affected across 31 states with use-by dates of March 8, 2024 and earlier.

    Product
    Harris Tetter Cheesy Melt, Pasteurized Prepared Cheese Product, Net Wt 32 oz (2 lbs) 907g. UPC 0 72036-70682 9. After Opening, Refrigerate Up to 8 weeks. Do Not Freeze. Proudly Distributed By: Harris Teeter, LLC, Matthews, NC 28105
    Category
    Food
    Distribution
    32 states
  • ModerateFDA (Food)·F-1528-2023·2023-09-27

    Refrigerated Pasteurized Cheese Products Recalled Due to Labeling Inconsistency

    Great Value and SE Grocers refrigerated cheese products are being recalled because labels contain inconsistent refrigeration requirements, which may result in improper storage by consumers.

    Product
    Pasteurized Prepared Cheese Product packaged under the following brands and sizes: 1. Great Value Original Melt'n Dip Easy Melt Cheese, Net Wt 16 oz (1 lb) 453g. UPC 0 78742-01512 5. Refrigerate after Opening. Distributed By: Walmart Inc., Bentonville, AR 72716 2. Great
    Category
    Food
    Distribution
    32 states
  • ModerateFDA (Drugs)·D-1168-2023·2023-09-27

    ChloraPrep One-Step Topical Applicators Recalled for Unsupported Shelf-Life Claims

    BD ChloraPrep One-Step topical applicators are recalled because the 36-month shelf life is not supported by stability data; the product may develop fungal contamination beyond 12 months.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1172-2023·2023-09-27

    Cequa cyclosporine ophthalmic solution recalled nationwide for subpotency

    Sun Pharmaceutical is recalling Cequa (cyclosporine) ophthalmic solution because certain lots contain less active ingredient than specified. Contact your doctor if using an affected product.

    Product
    CEQUA — CEQUA (CYCLOSPORINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2619-2023·2023-09-27

    MINISCAV Vacuum Pump Recalled for Inadequate Acceptance Documentation

    R A Medical Services has recalled 10 MINISCAV Vacuum Pump units distributed in Ohio due to inadequate documentation of the product acceptance activity during manufacturing.

    Product
    MINISCAV (tm) Vacuum Pump
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1524-2023·2023-09-27

    Giant Eagle Cheese Spread Recalled Due to Inconsistent Refrigeration Labels

    Giant Eagle Easy Melt cheese spread products have inconsistent refrigeration instructions on their labels. The varying label requirements may cause improper storage, creating potential food safety concerns.

    Product
    giant eagle Easy Melt, Pasteurized Prepared Cheese Spread. Net Wt 32 oz (2lb)907g. UPC 0 30034-06289 7. Refrigerate after Opening. Distributed by Giant Eagle, Inc., Pittsburgh, PA 15328-2809.
    Category
    Food
    Distribution
    32 states
  • ModerateFDA (Devices)·Z-2592-2023·2023-09-27

    Sentec Membrane Changer components recalled for manufacturing defect

    SenTec AG recalls Membrane Changer components for the Sentec Digital Monitoring System due to a potential manufacturing defect that could affect measurement accuracy.

    Product
    Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membrane Changer Reloadable, REF MC-R, each package contains 3 changers; and Membrane Changer Insert, REF MC-I, each package contains 5 inserts. All are components of the Sentec Digital Monitoring System (SDM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2590-2023·2023-09-27

    Arrow ErgoPack PICC Catheters Recalled for Incorrect Product Labeling

    Arrow International is recalling 190 units of Arrow ErgoPack One-Lumen PICC catheters (Lot 13F22J0617) because the product code and product name were incorrectly printed on the kit packaging. The units were distributed nationwide.

    Product
    Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (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
    0 states
  • 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 electrodes
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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 i
    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 w
    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-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 within
    Category
    Medical Device
    Distribution
    Distributed nationwide