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.

14076–14100 of 27206

  • HighFDA (Devices)·Z-0318-2024·2023-11-22

    Express Dry Seal Chest Drains Recalled for Insufficient Setup Instructions

    Atrium Medical Corporation is recalling Express Dry Seal Chest Drains (models 4000-100N and 4050-100N) due to inadequate instructions for proper catheter and patient tube connection setup. No injuries have been reported.

    Product
    Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0295-2024·2023-11-22

    IBA Proton Therapy System Patient Positioning Can Move Unexpectedly

    The IBA Proton Therapy System's patient positioning system can perform unexpected motions, risking patient crushing. Five US units and nine international units are affected.

    Product
    IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0303-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall: Loose Battery Pins May Cause Power Loss

    Physio-Control is recalling 8 LIFEPAK 15 defibrillators due to loose battery pins that may cause power loss. Affected units were distributed in Arizona, California, North Carolina, New Jersey, and New York.

    Product
    LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0409-2024·2023-11-22

    Frozen Tuna Ground Meat Recalled Due to Bacterial Contamination and Histamine

    Takumi brand frozen tuna ground meat is being recalled due to bacterial contamination (E. coli, coliforms) and elevated histamine. The product was distributed in CA, NV, TX, and NC in August-September 2021.

    Product
    Takumi brand frozen tuna ground meat, raw but ready to eat, vacuum packaged units in fiber boxes, net wt. 11 lbs. per box. individual units were sold by weight at the point of sale. Product of Fiji, and imported by Tokai Denpun USA INC. Bellevue, WA. Vacuum package label is read
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0300-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recall: Loose Battery Pins Risk Power Loss

    Physio-Control is recalling LIFEPAK 15 defibrillators due to a potential defect where battery pins may become loose, causing power issues.

    Product
    LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0309-2024·2023-11-22

    Medical Device Reagent Recalled for Unreliable Test Results

    Beckman Coulter's Transferrin reagent lot 2573 does not maintain stability as claimed, causing unreliable patient test results and control failures. The company confirmed the issue affects diagnostic accuracy.

    Product
    AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0299-2024·2023-11-22

    LIFEPAK 15 defibrillator recalled for potential battery power loss

    Physio-Control is recalling 5 LIFEPAK 15 defibrillators due to a potential defect where battery pins may become loose, resulting in power loss. No illnesses or injuries have been reported.

    Product
    LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0302-2024·2023-11-22

    LIFEPAK 15 Defibrillator Recalled for Loose Battery Pins Causing Power Loss

    Physio-Control is recalling LIFEPAK 15 defibrillators due to a potential for battery pins to become loose, which could cause power failure.

    Product
    LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0294-2024·2023-11-22

    CT Scanner Image Fusion Software Error Affecting Radiation Therapy Planning

    A software bug in Philips Brilliance CT scanners causes image-fusion errors, resulting in incorrect radiation therapy coordinates and potential treatment planning failures.

    Product
    Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0314-2024·2023-11-22

    Blood culture kit recalled due to expired internal components

    Medline's blood culture kit is being recalled because components inside the kit have expired before the kit's stated expiration date. This could affect the kit's ability to function properly.

    Product
    BLOOD CULTURE KIT, REF DYNDH1647B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0410-2024·2023-11-22

    Ground shrimp product recalled for undeclared Red #40 food coloring

    ORALE! CAMARON MOLIDO ground shrimp (Lot F-219) is recalled due to undeclared Red #40 food coloring. No illnesses have been reported.

    Product
    ORALE! CAMARON MOLIDO, GROUND SHRIMP, NET WT. 2 OZ. 57 g (in paper cartons) (12 packages per case of 2 oz each), PACKED & DISTRIBUTED BY: LISY CORP., INGREDIENTS: Precooked Shrimp and Salt., UPC: 096786202233.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0413-2024·2023-11-22

    Dried shrimp recalled for undeclared Red #40 food coloring

    Blum's Shrimp Shred dried shrimp is recalled due to undeclared Red #40 food coloring. Affected lot 230828 was distributed domestically in the United States.

    Product
    BLUM'S SHRIMP SHRED DRIED SHRIMP, COOKED IN SALT WATER, BLUM'S SEAFOOD PRODUCTS LLC, Net Wt. 50 LBS. (22.68 KG)
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0412-2024·2023-11-22

    Shrimp Recall Due to Undeclared Red Food Dye

    EL CHILAR natural shrimp (2 oz packages, Lot F-219) recalled due to undeclared Red #40 food coloring. The product was voluntarily withdrawn from domestic distribution.

    Product
    EL CHILAR CAMARON NATURAL, NATURAL SHRIMP, NET WT. 2 Oz. (57g) (in paper cartons) (12 packages per case of 2 oz each), DIST. BY: EL CHILAR., INGREDIENTS: PRECOOKED SHRIMP AND SALT, UPC: 874250003445.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0223-2024·2023-11-22

    Siemens Mobilett Mira wireless x-ray systems recalled for buzzer mounting defect

    Four Siemens Mobilett Mira wireless mobile x-ray systems are recalled due to incorrect buzzer component mounting that prevents acoustic signals during x-ray activation. The systems remain fully functional with visual LED indicators available for operator monitoring.

    Product
    Mobilett Mira wireless (VA20) mobile x-ray system(s)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0415-2024·2023-11-22

    Hemp oil gummies recalled for undeclared sub-ingredients in sunflower butter

    Tay's Sales and Distribution is recalling Full Spectrum Cold Pressed Hemp Oil Gummies due to undeclared sub-ingredients in the sunflower butter component. The products were distributed in Iowa and Illinois.

    Product
    Full Spectrum Cold Pressed Hemp Oil Gummies, Blackberry, 1.41 oz (4-count) and 8oz (15-count).
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-0411-2024·2023-11-22

    Shrimp product recall due to undeclared Red #40 food coloring

    ORALE! CAMARON NATURAL shrimp in 2 oz. packages (Lot F-219) is recalled due to undeclared Red #40 food coloring. Approximately 7,584 units were distributed domestically.

    Product
    ORALE! CAMARON NATURAL, NATURAL SHRIMP, NET WT. 2 OZ. 57 g (in paper cartons) (12 packages per case of 2 oz each), PACKED & DISTRIBUTED BY: LISY CORP., INGREDIENTS: Precooked Shrimp and Salt., UPC: 096786203209.
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0339-2024·2023-11-15

    Diced yellow onions recalled for potential Salmonella Thompson contamination

    Gills Onions is recalling Cross Valley Farms diced yellow onions due to potential Salmonella Thompson contamination. The product was distributed across the United States and Canada.

    Product
    Cross Valley Farms 1/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIP
    Category
    Food
    Distribution
    36 states
  • CriticalFDA (Food)·F-0363-2024·2023-11-15

    Diced Yellow Onions Recalled for Potential Salmonella Thompson Contamination

    Gills Onions is recalling fresh diced yellow onions due to potential Salmonella Thompson contamination. Approximately 16,400 pounds of product was distributed across multiple U.S. states and Canadian provinces.

    Product
    4/5 LB CTN FRESH 1/4" DICED YLW ONIONS W/ZIPPER DARDEN
    Category
    Food
    Distribution
    36 states
  • CriticalFDA (Food)·F-0399-2024·2023-11-15

    Slivered Yellow Onions Recalled for Salmonella Contamination Risk

    Gills Onions is recalling Ready Set Serve slivered yellow onions because of potential Salmonella Thompson contamination. The FDA has classified this as a Class I recall.

    Product
    Ready Set Serve 2/5 LB CTN FRESH 1/4" SLIVERED YELLOW ONIONS W/ZIPPER
    Category
    Food
    Distribution
    36 states
  • CriticalFDA (Food)·F-0324-2024·2023-11-15

    Little Bear Fresh Kale Recalled for Possible Listeria Contamination

    Little Bear Fresh Kale from Safeway Fresh Foods LLC is being recalled due to possible Listeria monocytogenes contamination. The recall affects 191 cases distributed in Texas.

    Product
    Little Bear Fresh Kale, Net Wt. 16oz
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-0390-2024·2023-11-15

    Diced yellow onions recalled for potential Salmonella Thompson contamination

    Gills Onions, LLC is recalling specific lots of PEAK 4/5 lb fresh diced yellow onions due to potential Salmonella Thompson contamination. The affected product was distributed across Canada and multiple U.S. states.

    Product
    PEAK 4/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIPPER
    Category
    Food
    Distribution
    36 states
  • CriticalFDA (Food)·F-0371-2024·2023-11-15

    Sliced Red Onions Recalled Due to Potential Salmonella Contamination

    Gills Onions is recalling Imperial Fresh sliced red onions due to potential Salmonella Thompson contamination. The product was distributed across 31 U.S. states and Canadian provinces.

    Product
    Imperial Fresh 2/5 LB CTN FRESH 3/16" SLVERED RED ONIONS SYSCO
    Category
    Food
    Distribution
    36 states
  • CriticalFDA (Food)·F-0354-2024·2023-11-15

    Fresh Diced Yellow Onions Recalled for Potential Salmonella Thompson Contamination

    Gills Onions is recalling 4,160 pounds of fresh diced yellow onions due to potential contamination with Salmonella Thompson. The products were distributed across the United States and Canada.

    Product
    Gills Onions 4/5 LB CTN FRESH 1/2" DICED YELLOW ONIONS W/ZIPPER
    Category
    Food
    Distribution
    36 states
  • CriticalFDA (Food)·F-0389-2024·2023-11-15

    Diced yellow onions recalled due to Salmonella contamination risk

    Gills Onions is recalling PEAK brand diced yellow onions due to potential Salmonella contamination. Product was distributed across the United States and Canada.

    Product
    PEAK 2/5 LB CTN FRESH 1/4" DICED YELLOW ONIONS W/ZIP
    Category
    Food
    Distribution
    36 states