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.

8851–8875 of 27089

  • HighFDA (Food)·F-0060-2025·2024-10-30

    Farmers Juice Focus Greens Recalled Due to Incomplete Pasteurization

    Youngstown Grape Distributors is recalling Farmers Juice Focus Greens due to incomplete pasteurization, which may allow bacterial growth. Approximately 7,909 bottles with lot H240906-G are affected.

    Product
    Farmers Juice Focus Greens packaged in a 12 fl. oz. bottle; Ingredients: Cucumber, Celery, Fennel, Romaine Lettuce, Lemon, Mint, Green Cabbage, Ginger, Turmeric, Basil, & Matcha. UPC: 00860006798048
    Category
    Food
    Distribution
    39 states
  • HighFDA (Devices)·Z-0199-2025·2024-10-30

    Medex TranStar Kids Blood Sample Kit Pressure Monitoring Defect Recall

    Smiths Medical is recalling medex TranStar Kids blood sample kits due to a manufacturing defect in the pressure transducer that may cause inaccurate or interrupted pressure monitoring.

    Product
    medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0205-2025·2024-10-30

    Smiths Medical SurgiVet pressure transducer recalled for monitoring failures

    Smiths Medical is recalling SurgiVet Advisor Tech Accessories due to manufacturing defects in the pressure transducer that may cause inaccurate, interrupted, or failed pressure monitoring.

    Product
    smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0225-2025·2024-10-30

    Endoscopic Dilation Balloon Mislabeled with Incorrect Size Information

    Olympus EZDilate Wire Guided Balloons with Lot 408987 have mislabeled sizing information. The device label states 11 mm, 12 mm, and 13 mm, but actual balloon sizes are 8.5 mm, 9.5 mm, and 10.5 mm, which may result in prolonged surgery.

    Product
    EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years) populations to endoscopically dilate strictures of the alimentary tract. It is also indicated in adults for endoscopic dilatation of the Sphincter of Oddi with or without prior sphincterotomy.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0147-2025·2024-10-30

    Smiths Medical Portex Thermovent 1200 Recalled for Sterile Packaging Seal Issues

    Smiths Medical ASD Inc. is recalling the Thermovent 1200 medical device due to uncertainty in sterile packaging seal integrity. Approximately 141,196 units distributed worldwide are affected.

    Product
    smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0079-2025·2024-10-30

    Amingo Anesthesia System: Risk of Breathing Circuit Misconnection to Auxiliary Outlet

    Datex-Ohmeda Amingo anesthesia systems may allow a patient breathing circuit to be mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) instead of the proper outlet. The potential misconnection affects all 77 units worldwide.

    Product
    Amingo. OUS only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0170-2025·2024-10-30

    Medline Tubal Ligation Kits Recalled for Potential Sterility Compromise

    Medline is recalling certain tubal ligation procedure kits due to potential loss of sterility if the pouch seal becomes compromised during storage or handling.

    Product
    Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0212-2025·2024-10-30

    Baxter Operating Table Recalled for Battery Short-Circuit and Smoke Risk

    Baxter is recalling its TruSystem 7000 operating table worldwide due to customer reports of battery and connector short-circuits that emitted smoke. All serial numbers are affected.

    Product
    Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0190-2025·2024-10-30

    medex TranStar Pressure Monitoring Kit Recalled for Manufacturing Defect

    Smiths Medical is recalling the medex TranStar 72-inch Double Monitoring Kit due to a manufacturing defect in the pressure transducer that may cause inaccurate pressure readings or monitoring interruptions. Approximately 6,590 units have been distributed worldwide.

    Product
    medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0139-2025·2024-10-30

    Shimadzu Trinias Unity Catheterization Table Movement Control Defect

    Shimadzu has recalled 13 Trinias unity digital angiography systems because the catheterization table may continue moving unexpectedly when the direct memory button is released during simultaneous operation with the C-arm. The operator must use the stop button to halt the table.

    Product
    Trinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This system consists of the following main components: C arm, catherization table, image processing equipment, x-ray high voltage generator, x-ray tube. There are several types of each component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0063-2025·2024-10-30

    SureLife Foods Paleo Bars recalled for undeclared gluten

    SureLife Foods Paleo Bars labeled as gluten-free contain gluten above 20 ppm according to consumer advocacy group testing. Approximately 48,384 units were distributed in California and Oregon.

    Product
    Principal Display: SureLife Foods PALEO BARS, Net Wt. 14 oz. (392 g.)- 14 ct. individually wrapped bars (28 g. each) Certified Gluten Free, Certified Paleo Loaed with: Almonds, Honey, Shredded Coconut, Pumpkin Seeds, Brazil Nuts, Chia Seeds & More! Back Display: Ingredients:
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0168-2025·2024-10-30

    Medline IV TEAM PICC Kits Recalled Due to Potential Non-Sterile Product

    Medline IV TEAM PICC medical procedure kits may contain non-sterile product if the breather pouch vendor seal has been opened. The recall affects 120 units distributed worldwide including the US, Canada, and Panama.

    Product
    Medline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0157-2025·2024-10-30

    Medline medical procedure kits recalled due to potential non-sterile packaging defect

    Medline brand medical procedure convenience kits packaged in breather pouch lot 323080002 may be non-sterile if the vendor seal is opened or compromised. Affected kits are distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: a) KIT LINE INSERTION, REF CVI4730A; b) KIT LINE INSERTION, REF CVI4730A; c) LINE INSERTION TRAY, REF DYNJ20803D; d) CENTRAL LINE PACK-LF, REF DYNJ28368; e) CENTRAL LINE PACK-LF, REF DYNJ28368; f) PICC PAC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0011-2025·2024-10-30

    CADD Medication Cassette Reservoir Recalled for Weld Defect Risk

    Smiths Medical is recalling 385,558 units of CADD Medication Cassette Reservoirs due to a weakened weld joint that could cause medication leakage. Affected units were distributed worldwide; users should discontinue use of recalled lot numbers immediately.

    Product
    CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0017-2025·2024-10-30

    Phenylephrine HCl Injectable Drug Recalled for Manufacturing Practice Violations

    Fresenius Kabi is recalling 1,378 bags of phenylephrine HCl injection due to manufacturing violations. The recall affects 125 healthcare facilities nationwide.

    Product
    Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0162-2025·2024-10-30

    Medline Central Catheter Insertion Kit Recalled for Potential Non-Sterile Packaging

    Medline CENTRAL CATHETER INSERTION KIT (Ref CVI680C) is being recalled because certain units may be non-sterile due to potential seal failures in packaging. The recall affects 1,180 units distributed in the US, Canada, and Panama.

    Product
    Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0163-2025·2024-10-30

    Medline Dialysis Pack Recalled Due to Potential Non-Sterile Product Risk

    Medline is recalling 90 units of its dialysis convenience kit due to potential non-sterile product if the package seal is compromised. Affected units were distributed in the US, Canada, and Panama.

    Product
    Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0180-2025·2024-10-30

    Medline EYE PACK Medical Kits Recalled for Potential Non-Sterile Packaging

    Medline is recalling 160 units of EYE PACK medical procedure kits due to potential compromises in sterilization. If the vendor seal on the breather pouch is opened or unsealed, the contents may become non-sterile.

    Product
    Medline EYE PACK, REF LYN036EPESB; medical procedure convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0010-2025·2024-10-30

    CADD Medication Cassette Reservoirs recalled for potential medication leakage

    Smiths Medical is recalling CADD Medication Cassette Reservoirs because weakened weld joints may cause medication leakage. The defect affects 125,928 units distributed worldwide.

    Product
    CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0058-2025·2024-10-30

    Juice Recall: Incomplete Pasteurization in Happy Moose Tropical Roots

    Happy Moose Juice Tropical Roots is recalled due to incomplete pasteurization of certain bottles. Consumers should not consume products with lot number H240903-E and enjoy-by date 12/02/2024.

    Product
    Happy Moose Juice Tropical Roots packaged in a plastic 12 fl. oz. bottle. Ingredients: Mandarin Orange, Organic Carrot Juice, Organic Pineapple Juice, Lemon Juice, and Organic Turmeric Juice. UPC 860012096503
    Category
    Food
    Distribution
    39 states
  • HighFDA (Devices)·Z-0193-2025·2024-10-30

    Smiths Medical TranStar Pressure Transducers Recalled for Monitoring Defect

    Smiths Medical recalls medex TranStar DPT pressure transducers due to a manufacturing defect that may cause inaccurate or interrupted pressure monitoring. The defect stems from a leak or chip malfunction.

    Product
    medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0214-2025·2024-10-30

    Baxter Operating Table TruSystem 7000 V Recalled for Battery Short-Circuit Risk

    Baxter Healthcare is recalling the TruSystem 7000 V operating table due to reports of battery and connector short-circuits and smoke emissions. Four units with worldwide distribution are affected.

    Product
    Baxter Operating Table TruSystem 7000 V, Product code REF 1841050
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0160-2025·2024-10-30

    Medline Medical Procedure Kits Recalled Due to Non-Sterile Packaging Risk

    Medline Industries is recalling 2,740 surgical convenience kits with breather pouches that may result in non-sterile product if the vendor seal is opened. The recall affects units distributed in the US, Canada, and Panama.

    Product
    Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS, REF CDS984492B; 3) RV T&A PACK-LF, REF DYNJ0798129I; 4) DIRECT MICRO LARYNG PK-LF, REF DYNJ30591I; 5) APU LINE PACK, REF DYNJ37171A; 6) T&A PACK-LF, REF DYNJ40
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2025·2024-10-30

    Smiths Medical Arterial Kit recalled for pressure monitoring defect

    Smiths Medical ASD is recalling medex Arterial Kits due to a manufacturing defect in the TranStar Disposable Pressure Transducer that may cause inaccurate readings or device failure.

    Product
    medex Arterial Kit 1/EA, Product Code REF MX7827
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0015-2025·2024-10-30

    CADD Medication Cassette Reservoir recalled for weakened weld joint

    Smiths Medical is recalling CADD Medication Cassette Reservoirs due to a production equipment malfunction that weakened weld joints. This could cause medication leakage.

    Product
    CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP
    Category
    Medical Device
    Distribution
    0 states