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.

11151–11175 of 88183

  • 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-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 (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-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…
    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-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 (Food)·F-1811-2024·2024-09-25

    Moringa Butter Murukku Recalled for Undeclared Milk Allergen

    Bliss Tree Moringa Butter Murukku 400g is recalled because it contains undeclared milk, a common food allergen. Consumers with milk allergies should not consume this product.

    Product
    Bliss Tree Moringa Butter Murukku 400g UPC:8906087452836. Packaged in pouches, 8 pouches per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • 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-3155-2024·2024-09-25

    Shoulder implant recalled due to excessive bacterial endotoxin

    Tornier, Inc. is recalling one lot of the Stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS shoulder implant due to bacterial endotoxin exceeding safety specifications. The 5 affected units were distributed in Illinois, Wisconsin, Arizona, Nevada, and South Dakota.

    Product
    stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
    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-3144-2024·2024-09-25

    Anesthesia Extension Sets recalled due to potential Spin Lock connector leakage

    B. Braun Medical is recalling 19,050 AET36 Anesthesia Extension Sets due to potential product leakage from the Spin Lock Connector caused by excess solvent migration during manufacturing.

    Product
    AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold, Four-way Stopcock, Model/Catalog Number: 472036
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3145-2024·2024-09-25

    GE Healthcare ViewPoint Imaging System Recall for Data Vulnerability

    GE Healthcare is recalling three ViewPoint imaging systems due to a software vulnerability in Mirth Connect that could allow unauthorized access and manipulation of patient data.

    Product
    ViewPoint; system, imaging processing, radiological
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3142-2024·2024-09-25

    Alaris Pump Module 8100 Recalled for Bent Connector That May Disable Device

    CareFusion is recalling approximately 192,964 Alaris Pump Module Model 8100 infusion pumps that may have bent female connectors preventing device operation and delaying patient treatment.

    Product
    Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3180-2024·2024-09-25

    Beckman Coulter Analyzer Recalled for Pneumatic Tubing Defects

    Beckman Coulter is recalling the DxI 9000 Access Immunoassay Analyzer due to undersized pneumatic tubing in the reagent storage module, which can cause air leaks and compressor failures, potentially leading to test errors and delayed results.

    Product
    Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Model Number C21510, RSM Pneumatic Tubing Kit item #2, REF C11137; in vitro diagnostic instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3173-2024·2024-09-25

    Hemodialysis Bloodline Tubing Recall Over Incomplete Connector Insertion Risk

    B Braun is recalling SL BLOODLINE FOR FMC 2008 SERIES hemodialysis tubing nationwide due to incomplete connector insertion that may cause blood flow restrictions during treatment.

    Product
    SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3164-2024·2024-09-25

    Endo Retrieval Pouches Recalled; Tube May Detach During Endoscopic Use

    Endo retrieval pouches are recalled because the tube may detach and fall into the surgical site during use. Approximately 81,241 units distributed in Georgia, Missouri, and Pennsylvania are affected.

    Product
    1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3" x 6", sterile; 2. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2000, 5" x 7", sterile; 3. Tech Medical Services, Inc. Detachable Endo Retrieval Pouch, REF TM2002, 8" x 10"…
    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-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
  • 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
  • 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-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-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)…
    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-3160-2024·2024-09-25

    GE Healthcare Centricity Universal Viewer Recall for Report Display Issue

    GE Healthcare is recalling 803 units of the Centricity Universal Viewer Zero Footprint Client because the latest addended report may not display by default in specific browsers.

    Product
    GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344-008; b) 2110344-009; c) 2110344-010; d) 2110344-011; e) 2110344-013; f) 2110344-019; g) 2110344-025; h) 2110344-029; i) 2110344-030; j) 2110344-032 ; Radiological…
    Category
    Medical Device
    Distribution
    0 states
  • 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