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.

14276–14300 of 27263

  • HighFDA (Devices)·Z-0255-2024·2023-11-15

    Stryker Disposable Bipolar Forceps Recall for Incorrect Expiration Date Labeling

    Stryker Corporation recalls Disposable Spetzler-Malis Bipolar forceps due to labeling error. Products are labeled for 54-month shelf life but have actual 36-month shelf life, risking use of expired sterile surgical equipment.

    Product
    Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0221-2024·2023-11-15

    Pendant Patient Alarm Battery Defect Prevents Emergency Alerts

    Securitas Healthcare LLC recalls Arial Water Resistant Pendants (Models 59361 and 2560-59361) because premature battery depletion may prevent emergency alarms from reaching the wireless alert system. Affected patients may not receive emergency assistance when needed.

    Product
    Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361; mobile patient alarm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0258-2024·2023-11-15

    DJO EMPOWR Knee Punch Handle Tip May Break During Surgery

    Encore Medical is recalling DJO EMPOWR Knee Punch Handles due to a manufacturing defect that may cause the handle tip to break during surgery, potentially disrupting the procedure.

    Product
    DJO EMPOWR Knee Punch Handle, REF: 801-05-040
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-0274-2024·2023-11-15

    DigitalDiagnost 4 Radiographic Systems Risk of Ceiling Mount Failure

    DigitalDiagnost 4 High Performance radiographic systems may fail and fall from ceiling mounts. The FDA recalls 366 units distributed nationwide.

    Product
    DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0131-2024·2023-11-15

    Burette Assembly Recalled for Manufacturing Defect Causing Potential Leakage

    B. Braun recalls 30 ML 2PORT burette assemblies (lot 0061766049) for potential leakage due to manufacturing defect. Leakage risks delayed therapy, bloodstream infection, and medication exposure to patients and healthcare workers.

    Product
    30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0088-2024·2023-11-15

    Synthroid Levothyroxine Tablets Recalled for Incorrect Barcode Labeling

    AbbVie is recalling 864 cartons of Synthroid (Levothyroxine Sodium) 125mcg tablets due to incorrect barcode labeling. About 1 in 40 blister packs has a barcode showing 200mcg instead of 125mcg, risking dosage confusion.

    Product
    SYNTHROID — SYNTHROID (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Devices)·Z-0226-2024·2023-11-15

    Surgical C-arm systems recalled for missing warning label and spacer

    Philips is recalling Zenition 50 & 70 surgical C-arm systems distributed to Puerto Rico, Guam, and the Virgin Islands due to missing warning labels and safety spacers. These missing components may compromise radiation safety during surgical use.

    Product
    Zenition 50 & 70 Mobile Surgery C-arm
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0230-2024·2023-11-15

    Surgical C-arm Systems Recalled for Missing Warning Labels and Tube-Spacers

    Philips recalled surgical C-arm systems in US territories without required warning labels and missing the Source-to-Skin Distance Spacer. Facilities should contact Philips for instructions on obtaining missing components.

    Product
    Veradius Unity Mobile Surgery C-arm
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0288-2024·2023-11-15

    EVIS EXERA III Gastrointestinal Videoscope Recalled Due to Sterilization Failures

    Olympus Corporation is recalling 1,687 units of the EVIS EXERA III Gastrointestinal Videoscope nationwide due to sterilization failures that may occur when devices are reprocessed without adequate drying time in the endoscope channel.

    Product
    EVIS EXERA III Gastrointestinal Videoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0328-2024·2023-11-15

    Infant Probiotic Supplement Recall: Abbott Similac Tri-Blend Unsafe Additive

    Abbott Laboratories has recalled Similac Probiotic Tri-Blend infant supplement packets due to regulatory violations: the product was marketed without FDA approval as a new drug and contains an unsafe food additive.

    Product
    Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0259-2024·2023-11-15

    Monitron II Waveform Analyzer Screen Freeze Defect in Ventilator Models

    Percussionaire Corporation recalled 212 Monitron II Waveform Analyzers due to screen freeze issues on visual displays. Affected units were serviced with PAL microprocessor chips and firmware updates.

    Product
    Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0283-2024·2023-11-15

    Philips EPIQ Diagnostic Ultrasound Systems May Display Delayed Images

    Philips is recalling 83 EPIQ diagnostic ultrasound systems that may display delayed instead of real-time images due to a software issue, potentially affecting diagnostic imaging quality.

    Product
    Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234)
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Food)·F-0372-2024·2023-11-15

    Diced Yellow Onions Recalled Due to Potential Salmonella Contamination

    Gills Onions, LLC is recalling Imperial Fresh diced yellow onions due to potential Salmonella Thompson contamination. The 1,940-pound recall affects products distributed in the United States and Canada.

    Product
    Imperial Fresh 2/5 LB CTN FRESH 1/2" DICED YLW ONIONS W/ZIP
    Category
    Food
    Distribution
    36 states
  • HighFDA (Devices)·Z-0132-2024·2023-11-15

    IV Injection Set Recall: Risk of Leakage and Bloodstream Infection

    B. Braun Medical is recalling 12,800 units of TERUMO IV injection sets (Lot 0061753485) due to a manufacturing defect that may cause leakage, delaying therapy and increasing risk of bloodstream infection.

    Product
    TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only. IV injection set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0321-2024·2023-11-15

    Greenhead Lobster Products Recalls Frozen and Fresh Lobster Meat for Listeria

    Greenhead Lobster Products is recalling frozen and fresh ready-to-eat lobster meat that may be contaminated with Listeria monocytogenes. The recall affects multiple states.

    Product
    Frozen and fresh RTE Lobster meat (1 lb. packages to 12 lb. case) 1. Greenhead Lobster HPP Fresh Cooked Claw and Knuckle Meat GHL-CKF - Fresh - 1 lb. oxygen permeable bag, master cased in a 12 lbs. Styrofoam box 2. Greenhead Lobster Fresh Cooked Claw and Knuckle Meat GHL-CKF -C
    Category
    Food
    Distribution
    28 states
  • HighFDA (Devices)·Z-0284-2024·2023-11-15

    Philips Affiniti 70 Ultrasound System Software Defect May Cause Delayed Images

    Philips is recalling 7 Affiniti 70 diagnostic ultrasound systems with software version 10.0 due to a defect that may produce delayed imaging instead of real-time images.

    Product
    Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0265-2024·2023-11-15

    Temporary Dental Fillings Recalled Due to Improper Storage Conditions

    Family Dollar is recalling DENTEMP ONE STEP temporary dental fillings sold between June 2023 and October 2023 in 22 states because they were stored outside labeled temperature requirements, which may affect product performance.

    Product
    DENTEMP ONE STEP .077OZ, SKU 902139
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0129-2024·2023-11-15

    SA3000 intravenous adapters recalled for manufacturing defect causing leakage

    B. Braun is recalling SA3000 intravenous adapters due to a manufacturing defect that may cause leakage. This could delay therapy, increase bloodstream infection risk, and expose patients and workers to hazardous medication.

    Product
    SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0133-2024·2023-11-15

    Medical administration set for radiation therapy recalled due to leakage risk

    B. Braun Medical recalls THERASPHERE ADMIN SET due to manufacturing defects causing potential leakage. Leakage may delay therapy, increase bloodstream infection risk, and expose patients and healthcare workers to hazardous medication.

    Product
    THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use administration set used to deliver Yttrium-90 glass microspheres for internal radiation therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0316-2024·2023-11-15

    Hinterland Dairy Farmstead Cheese Mango Habanero Recalled for E. coli Risk

    Hinterland Dairy Inc is recalling Farmstead Cheese Mango Habanero (8oz packages, Lot 1670) distributed in Iowa due to potential E. coli contamination. Consumers should dispose of the product.

    Product
    Hinterland Dairy Farmstead Cheese Mango Habanero, a jack-style cheese, packaged in 8oz packages.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0228-2024·2023-11-15

    X-ray imaging systems recalled for missing warning label and spacer

    Philips X-ray imaging systems delivered to Puerto Rico are missing warning labels and Source-to-Skin Distance Spacers. These missing safety components could affect user safety during imaging procedures.

    Product
    Allura Xper IGTS Fixed Systems
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0290-2024·2023-11-15

    Medical device blood oxygenation system recalled due to defective weld

    Maquet Medical Systems USA is recalling 1,022 Cardiohelp-i blood oxygenation systems due to an insufficient weld on a critical component that may break under manual force.

    Product
    Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0264-2024·2023-11-15

    Family Dollar Pregnancy Test Recalled Due to Improper Storage Conditions

    Family Dollar is recalling 329,044 VERIQUICK pregnancy tests due to improper storage outside labeled temperature requirements. Affected units were sold at Family Dollar stores June-October 2023.

    Product
    VERIQUICK PREGNANCY TEST 1CT, SKU 901260
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0236-2024·2023-11-15

    Laboratory Lipase Test Slides Recalled for Measurement Bias Risk

    Ortho-Clinical Diagnostics is recalling VITROS Lipase Slides due to measurement abnormalities that could result in falsely low or elevated test results. This could delay diagnosis of acute pancreatitis or cause diagnostic confusion.

    Product
    VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartridge)
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0282-2024·2023-11-15

    Orthopedic Shoulder Implant Devices Recalled Due to Packaging Mix-Up

    Encore Medical recalls RSP Humeral Socket Insert implant components due to a packaging error where two different devices were swapped. This could prevent surgeons from having the correct implant available during shoulder surgery.

    Product
    RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
    Category
    Medical Device
    Distribution
    13 states