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.

21551–21575 of 88183

  • HighFDA (Devices)·Z-0393-2023·2022-12-14

    Bipolar forceps recall for incomplete operating and maintenance instructions

    Carefusion is recalling neurosurgical bipolar forceps due to incomplete Instructions for Use. The product is missing critical information about power supply interface and cleaning/maintenance procedures.

    Product
    Carefusion V. Mueller Neuro/Spine JEWELERS BIPOLAR FORCEPS 0.4MM TIP, CURVED, # 7 OVERALL LENGTH 4-3/4" (120MM), REF F-3007
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0394-2023·2022-12-14

    Surgical Bipolar Forceps Recalled for Missing Safety Instructions

    Carefusion is recalling surgical bipolar forceps due to incomplete instructions for use. The missing information covers power supply interface and cleaning and maintenance procedures.

    Product
    Carefusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP OVERALL LENGTH 4-3/4" (120MM), REF F-3010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0372-2023·2022-12-14

    Shoulder Surgical Navigation System Warning for Bone Stability

    A warning has been added to the NextAR Shoulder surgical navigation platform advising verification of adequate coracoid bone stability. Inadequate stability could lead to bone fracture during reverse shoulder surgery.

    Product
    NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0370-2023·2022-12-14

    Full Vision Trackmaster Treadmill Safety Tether May Fail During Falls

    Eight Full Vision Trackmaster treadmills may fail to stop if the magnetic safety tether is pulled during a fall, due to a PCB circuit defect in the tether control system.

    Product
    FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST2 220V, Model #317-07927GE CHINA
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Drugs)·D-0076-2023·2022-12-14

    Intravenous Sodium Chloride Injection Recall for Potential Bag Leakage

    B. Braun Medical is recalling 756 bags of 0.9% sodium chloride injection (saline) due to potential leakage that could compromise sterility. The recall affects product distributed in Florida, New Jersey, and Pennsylvania.

    Product
    SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0077-2023·2022-12-14

    Desmopressin Acetate Tablets Recalled by Manufacturer for Subpotency

    RemedyRepack Inc. is recalling Desmopressin Acetate Tablets due to subpotency. The affected tablets may not provide the intended therapeutic effect.

    Product
    Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816; Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC #: 70518-3493-00.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0378-2023·2022-12-14

    Bipolar Forceps Recalled for Missing Power Supply and Cleaning Instructions

    Carefusion 2200 Inc is recalling 203 units of V. Mueller SEMKIN Bipolar Forceps due to incomplete Instructions for Use. The IFU is missing critical content related to power supply interface and cleaning/maintenance procedures.

    Product
    Carefusion V. Mueller" SEMKIN BIPOLAR FORCEPS WITH STOP, 0.7MM TIP OVERALL LENGTH 5-1/2" (140MM), REF F-1040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0419-2023·2022-12-14

    LineSider Spinal System Screws Recalled for Potential Weld Separation

    Integrity Implants is recalling 1,702 LineSider Spinal System pedicle screws due to potential weld separation between screw head components that could result in device failure.

    Product
    LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0374-2023·2022-12-14

    Bipolar Surgical Forceps Recalled for Incomplete Instructions for Use

    Carefusion is recalling 418 units of bipolar surgical forceps because the provided instructions lack critical content about power supply interface and maintenance. Complete manufacturer instructions are necessary for safe device operation.

    Product
    CareFusion V. Mueller SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL LENGTH 7-3/4" (195MM) , REF F-1002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0401-2023·2022-12-14

    Bipolar Forceps Recall: Missing Device Use and Maintenance Instructions

    CareFusion bipolar forceps recalled due to incomplete Instructions for Use. Missing documentation covers power supply interface and cleaning/maintenance procedures.

    Product
    CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL LENGTH 10-1/2" (265MM), REF F-5016
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0365-2023·2022-12-14

    Full Vision TrackMaster Treadmill Emergency Stop Failure Recall

    Full Vision Inc. is recalling 38 TrackMaster TMX428 220V treadmills due to a rare circuit failure that may prevent the magnetic safety tether from stopping the machine during a fall.

    Product
    FULL VISION INC. TRACKMASTER,TREADMILL TMX428 220V, Model #317-07927
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0356-2023·2022-12-14

    Dover Closed Urethral Tray Recalled for Potential Drainage Blockage Risk

    Cardinal Health is recalling Dover Closed Urethral Catheter Trays due to potential blockage of the urinary drainage bag inlet port, which may prevent proper urine drainage and increase the risk of urinary retention.

    Product
    Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bladder of a patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0368-2023·2022-12-14

    Treadmill safety mechanism may fail to stop during fall

    Full Vision Inc. Trackmaster treadmills (Model #317-07926GE) may fail to stop during a fall if the magnetic safety mechanism malfunctions. 69 units are affected.

    Product
    FULL VISION INC. TRACKMASTER, TREADMILL GE T2100-ST1 110V, Model #317-07926GE
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0358-2023·2022-12-14

    Dover Urinary Catheter Drainage Tray Recall Due to Blockage Risk

    Cardinal Health is recalling Dover Closed Urethral Tray urinary drainage systems due to potential blockage of the drainage bag inlet port, which may prevent proper bladder emptying and increase the risk of urinary retention.

    Product
    Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended for urinary drainage from the bladder of a patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0187-2023·2022-12-14

    Taylor Farms Jicama Sticks recalled due to metal fragment contamination

    Taylor Farms Northwest is recalling 539 units of Taylor Farms Jicama Sticks because a metal fragment was found in a package. The product was distributed in Washington with sell-by dates of 11/13/2022 through 11/17/2022.

    Product
    Taylor Farms Jicama Sticks, Refrigerated & Ready To Eat product, packaged in a clear plastic clamshell container, net wt. 14 oz. Distributed by Taylor Farms NW Kent, WA 98032. UPC 30223 11248.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0190-2023·2022-12-14

    Weis Quality Premium Ice Cream Recalled for Undeclared Soy and Coconut

    Weis Quality ice cream contains undeclared soy and coconut allergens. Consumers with allergies should discard or return the product.

    Product
    Weis Quality Premium Ice Cream Sea Salt Caramel Ripple 1.5 Quart (1.42 L) UPC 041497-01288
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0418-2023·2022-12-14

    Spinal Implant Screws Recalled Due to Potential Weld Failure

    LineSider Spinal System screws are recalled due to potential weld separation between components that could cause the Tulip Head to detach from the Screw Shank. The recall affects 1,227 screws distributed nationwide.

    Product
    LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0188-2023·2022-12-14

    Taylor Farms Guacamole Tray Recalled for Metal Fragment

    Taylor Farms is recalling its 61 oz Guacamole Tray because a metal fragment approximately 3/4 inch was found in a retail package. The recall affects 161 units distributed in Washington.

    Product
    Taylor Farms Guacamole Tray - Large, Refrigerated & Ready To Eat product, packaged in a plastic round container, net wt. 61 oz. The tray contains Cucumber, Baby Carrots, Jicama, Red Bell Pepper, Yellow Bell Pepper, and Blended Guacamole (Hass Avocados). Distributed by Taylor…
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0413-2023·2022-12-14

    Bipolar Forceps Recall: Incomplete Instructions for Surgical Device

    BD recalls CareFusion bipolar forceps (Ref F-5301) due to incomplete Instructions For Use. The IFU is missing information about power supply interface and cleaning and maintenance.

    Product
    CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1.5MM TIP, STRAIGHT, INSULATED OVERALL LENGTH 8-3/4" (225MM), REF F-5301
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0359-2023·2022-12-14

    Dover Closed Urethral Tray Recalled Due to Drainage Port Blockage Risk

    Cardinal Health recalls Dover Closed Urethral Tray due to potential blockage of the urinary drainage bag inlet port that could prevent urine drainage and increase risk of urinary retention if bladders are not emptied timely.

    Product
    Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0193-2023·2022-12-14

    Big Sky Chocolate Chunk Granola Recalled for Undeclared Milk Allergen

    SUBURBAN BREAD CO. is recalling Big Sky Chocolate Chunk Granola (14oz pouches) because product labeling fails to declare milk, a sub-ingredient present in the granola. This poses a risk to consumers with milk allergies.

    Product
    Big Sky Chocolate Chunk Granola, Net Wt 14oz; UPC 02503 00475
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0379-2023·2022-12-14

    Bipolar Forceps Recall: Missing Device Instructions for Use

    Carefusion is recalling bipolar forceps due to missing instructions for use. The corrected instructions address power supply interface, cleaning, and maintenance.

    Product
    Carefusion V. Mueller SEMKIN BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LENGTH 6" (150MM), REF F-1045
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0392-2023·2022-12-14

    Carefusion Bipolar Forceps Recalled for Incomplete Instructions for Use

    Carefusion is recalling the V. Mueller Jewelers Bipolar Forceps due to incomplete Instructions for Use missing power supply interface and cleaning/maintenance instructions. The recall affects 236 units distributed nationwide and internationally.

    Product
    Carefusion V. Mueller JEWELERS BIPOLAR FORCEPS 0.4MM TIP, STRAIGHT OVERALL LENGTH 4" (100MM), REF F-3000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0186-2023·2022-12-14

    Betty Buzz Sparkling Grapefruit Recalled for Off-Odor

    Betty Buzz LLC is recalling Betty Buzz Sparkling Grapefruit non-alcoholic beverage nationwide due to detected off-odor in the product. The recall affects 939 cases containing 22,536 bottles.

    Product
    Betty Buzz Sparkling Grapefruit - Non-alcoholic Beverage & Mixer Container Description: 4 x 9oz Bottles in Pack 24 units per case
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0399-2023·2022-12-14

    CareFusion Bipolar Forceps Recalled for Incomplete Instructions for Use

    CareFusion is recalling the V. Mueller Neuro/Spine Titanium Bipolar Forceps due to missing Instructions for Use content covering device power supply interface, cleaning, and maintenance procedures.

    Product
    CareFusion V. Mueller Neuro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL LENGTH 9-1/2" (240MM), REF F-5010
    Category
    Medical Device
    Distribution
    Distributed nationwide