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.

9301–9325 of 27089

  • HighFDA (Devices)·Z-3166-2024·2024-09-25

    Philips Allura Xper Fluoroscopy Systems Cable Hose Carrier Detachment

    Philips Allura Xper FD series fluoroscopy systems may have detached cable hose carriers due to broken plastic or bolts. A detachment could cause parts to fall and potentially result in injury.

    Product
    System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 Allura Xper FD20/20 722035 Allura Xper FD20 OR Table 722029 Allura Xper FD20/10 722028 Allura Xper FD20 722027 Allura Xper FD10/10 722026 Allura Xper FD10 722025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3181-2024·2024-09-25

    HAWK Warming Grid recalled for incorrect expiration date

    Safeguard US Operating LLC is recalling the HAWK Warming Grid (Item 59-300) due to an incorrect expiration date. The affected units may not function safely if used beyond the actual expiration date.

    Product
    HAWK Warming Grid, Item Number: 59-300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3169-2024·2024-09-25

    Siemens Atellica Microalbumin Diagnostic Test Kits Recalled for Measurement Error

    Siemens Healthcare Diagnostics is recalling Atellica CH and ADVIA Chemistry Microalbumin test kits worldwide because they may not properly measure microalbumin in urine samples, potentially causing falsely low results that could delay diagnosis of kidney disease.

    Product
    Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3168-2024·2024-09-25

    Philips MultiDiagnost Eleva X-ray system cable hose carrier detachment

    Philips is recalling 109 MultiDiagnost Eleva X-ray systems worldwide due to potential cable hose carrier detachment from broken plastic or bolts, which could cause parts to fall and result in injury.

    Product
    System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034 MultiDiagnost Eleva with Flat Detector 708032 MultiDiagnost Eleva
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3151-2024·2024-09-25

    Boston Scientific VTC Nephrostomy Catheter Kit Recalled for Sterile Barrier Defect

    Boston Scientific is recalling VTC Regular Kit Nephrostomy Catheter System kits due to potential holes in the sterile barrier of the device pouch, which may compromise device sterility.

    Product
    VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3149-2024·2024-09-25

    Nephrostomy Catheter System Kit Recalled Due to Sterile Barrier Defect

    Boston Scientific is recalling Flexima Regular Kit Nephrostomy Catheter System kits due to potential holes in the sterile barrier pouch that may compromise device sterility.

    Product
    Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3175-2024·2024-09-25

    Hemodialysis bloodline tubing recalled for improper connector insertion risk

    B. Braun is recalling approximately 4.98 million STREAMLINE FRESENIUS FOR DAVITA hemodialysis bloodline tubes due to risk of improper connector insertion, which could cause blood flow occlusion during dialysis treatment.

    Product
    STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095DA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1813-2024·2024-09-25

    Bliss Tree Millet Butter Recalled for Undeclared Milk Allergen

    Bliss Tree Millet Butter is being recalled because it contains undeclared milk, a common allergen. The product was distributed to wholesalers and retailers in five states and to online customers nationwide.

    Product
    Bliss Tree Millet Butter Karasev 200g UPC:8906087451686. Packaged in a box, 13 boxes per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3159-2024·2024-09-25

    Convenience kits recalled for containing defective medical syringes

    ROi CPS LLC is recalling medical convenience kits distributed with Merit syringes that were subsequently recalled by their manufacturer. Approximately 3,387 kits with multiple lot numbers were affected.

    Product
    regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3161-2024·2024-09-25

    BiomarC EX Fiducial Marker System recalled for missing MRI safety component

    Carbon Medical Technologies is recalling the BiomarC EX Fiducial Marker System because patients did not receive the required MRI Insert component needed for safe use during MRI procedures.

    Product
    BiomarC EX Fiducial Marker System, Catalog Number 040165
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3140-2024·2024-09-25

    Alaris EtCO2 Module Model 8300 Recalled Due to Bent Connector

    CareFusion 303, Inc. recalls 180 Alaris EtCO2 Module Model 8300 units with potentially bent female connectors that may prevent device operation, risking delays in infusion and monitoring.

    Product
    Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3165-2024·2024-09-25

    Philips Azurion X-ray Systems: Cable Hose Carrier Detachment Risk

    Philips recalls Azurion X-ray imaging systems due to potential cable hose carrier detachment from broken plastic or bolts, which may cause parts to fall and create injury risk.

    Product
    System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion 7 M12 722228 Azurion 5 M20 722227 Azurion 5 M12 722226 Azurion 7 B20 722225 Azurion 7 B12 722224 Azurion 7 M20 722223 Azurion 7 M12 722222 Azu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3170-2024·2024-09-25

    Diagnostic test reagent may produce inaccurately low patient results

    Siemens Healthcare's ADVIA Chemistry Microalbumin diagnostic test may produce falsely low results. Eight lots do not meet High-Dose Hook Effect and Prozone Effect specifications, potentially affecting microalbumin detection accuracy.

    Product
    ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in the quantitative measurement of microalbumin in human urine on ADVIA Chemistry systems/ Atellica CH and Atellica CI Analyzers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3141-2024·2024-09-25

    Alaris Syringe Module Model 8110 Infusion Pumps Recalled for Bent Connectors

    CareFusion's Alaris Syringe Module Model 8110 infusion pumps are being recalled because affected units may have bent female connectors that can prevent device operation and delay infusions. Approximately 20,145 units have been distributed worldwide.

    Product
    Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3185-2024·2024-09-25

    Acceava Respiratory Strep A test kits recalled for unlicensed distribution

    Cypress Medical Products recalls Acceava Respiratory Strep A diagnostic test kits nationwide due to a classification error that caused them to be shipped to customers without proper licensing.

    Product
    Acceava Respiratory Strep A, CLIA Waived, Catalog Number 4580295008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1810-2024·2024-09-25

    Bliss Tree Pakoda Recalled Due to Undeclared Milk Allergen

    Bliss Tree Millet Butter Ribbon Pakoda is recalled because it contains undeclared milk. The product was distributed to retailers and wholesalers in five states and nationwide online.

    Product
    Bliss Tree Millet Butter Ribbon Pakoda 200g UPC:8906087451624. Packaged in a box, 13 boxes per case. Bliss Tree Millet Butter Ribbon Pakoda 400g UPC:8906087452843. Packaged in pouches, 8 pouches per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3183-2024·2024-09-25

    Emergency Hypothermia Management Kits Recalled for Incorrect Expiration Dates

    Safeguard US Operating LLC is recalling 567 units of HAWK warming kits due to incorrect expiration date labeling. The kits were distributed nationwide in 16 states.

    Product
    Kits of Convenience containing 1 of the 2 Item Numbers: 1. Item Number: 59-300 HAWK Warming Grid, 2. Item Number: 59-320 HAWK Advanced Hypothermia Management Set. Convenience kits labeled as follows: Combat Life Saver - Intermediate (Product Number: 83-323-CB) contain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3162-2024·2024-09-25

    Marodyne-LiV vibration exerciser recalled for power supply voltage defect

    Marodyne-LiV low-intensity vibration exercisers with certain serial numbers are recalled due to a power supply voltage drop that unexpectedly interrupts treatment. Manual activation is required to restart the device.

    Product
    Marodyne-LiV, part number 3045-133, Low intensity vibration exerciser supporting osteoporosis treatment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3186-2024·2024-09-25

    VariSoft Infusion Sets recalled due to incorrect secondary packaging

    Unomedical A/S is recalling specific VariSoft Infusion Sets packaged in boxes incorrectly branded as 'Trusteel Infusion Set' instead of 'VariSoft.' No injuries or illnesses have been reported.

    Product
    VariSoft Infusion Set, Single Use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3184-2024·2024-09-25

    BinaxNOW Respiratory Strep A Test Kits Shipped to Unlicensed Purchasers

    Cypress Medical Products is recalling BinaxNOW Respiratory Strep A Test Kits due to an inventory system error that resulted in shipment to customers without proper licensing to purchase medical devices.

    Product
    BinaxNOW Respiratory Strep A Test Kit, CLIA Waived, Catalog Number 730025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3154-2024·2024-09-25

    McKesson 60 mL Syringes Recalled Lacking FDA Clearance

    Cypress Medical Products is recalling McKesson 60 mL syringes that lack FDA clearance. The syringes were inadvertently shipped from a distribution center due to an order processing error and were on quarantine.

    Product
    General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety, Catalog Number 869662, McKesson Brand Catalog Number: 102-S60C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0659-2024·2024-09-25

    Acetazolamide tablets recalled for discoloration across US distribution

    Rubicon Research Private Limited is recalling 3,984 bottles of Acetazolamide 125 mg tablets nationally due to discoloration. Affected lot is 30575HF1 with expiration November 2026.

    Product
    ACETAZOLAMIDE — ACETAZOLAMIDE (ACETAZOLAMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1548-2024·2024-09-18

    Olympus Electrosurgical Knives Recalled Due to Breakage During Use

    Olympus Corporation recalled 2,525 electrosurgical knives (KD-645L) nationwide after reports of serious injury from knives breaking off during use. Users must follow Instructions for Use regarding proper electrosurgical unit compatibility and output settings.

    Product
    Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-645L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2974-2024·2024-09-18

    Pneupac ventilator control knob may shift unintentionally during operation

    Smiths Medical ASD Inc. is recalling 10,240 Pneupac paraPAC plus 310 ventilator kits due to risk of unintended tidal volume knob movement, affecting all serial numbers worldwide.

    Product
    Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1547-2024·2024-09-18

    Olympus Electrosurgical Knives Recalled for Breaking During Use

    Olympus Corporation recalls 4,507 Triangle Tip Electrosurgical Knives (Model KD-640L) due to device fragmentation during use. The issue is linked to reports of serious injury and improper adherence to usage instructions.

    Product
    Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the upper digestive tract Model: KD-640L
    Category
    Medical Device
    Distribution
    Distributed nationwide