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-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-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-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-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-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-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 (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-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-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-3139-2024·2024-09-25

    Alaris PCA Pump Module May Have Defective IUI Connector

    CareFusion recalls approximately 10,460 Alaris PCA Module Model 8120 infusion pumps worldwide due to potentially bent female IUI connectors that may prevent proper device operation and delay treatment initiation.

    Product
    Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3138-2024·2024-09-25

    Infusion Pump Alaris System PC Unit 8015 Recalled for Bent Connector

    CareFusion's Alaris System PC Unit Model 8015 infusion pumps are being recalled due to a bent female IUI connector affecting over 125,000 devices. The defect may prevent the device from operating properly or delay infusion or monitoring startup.

    Product
    Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3152-2024·2024-09-25

    Medtronic CareLink 2090 Programmer Recall: Autonomous Cursor Motion

    Medtronic is recalling CareLink 2090 Programmers (serial number prefixes PKK0 and PKK1) worldwide due to potential autonomous cursor motion when Finger Touchscreen capability is enabled with software version 3.2 or higher. Approximately 18,788 units are affected.

    Product
    2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE CRM; b) 209031, Product Description: PROGRAMMER 209031 PORTABLE CRM; c) 2090AA, Product Description: PROGRAMMER 2090AA PORTABLE CRM; d) 2090AA4, Pr
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1812-2024·2024-09-25

    Curry Leaves Snack Recalled Due to Undeclared Milk Allergen

    Bliss Tree Curry Leaves Butter Murukku is recalled due to undeclared milk. The product was distributed to retailers in CA, NJ, GA, AZ, MD, and nationwide online.

    Product
    Bliss Tree Curry Leaves Butter Murukku 400g UPC:8906087452867. Packaged in pouches, 8 pouches per case.
    Category
    Food
    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
  • 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) 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-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
  • 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-3087-2024·2024-09-18

    Smiths Medical Tracheotomy Tube Kits Recalled for Pilot Balloon Disconnection

    Smiths Medical is recalling approximately 12,234 BLUselect, BLUgriggs, and BLUperc tracheotomy tube kits due to a manufacturing defect that may cause the pilot balloon to disconnect from the inflation line.

    Product
    smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/080; 2) BLUgriggs
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2972-2024·2024-09-18

    Infusomat Space Infusion Pump Recall Due to Sensor Malfunction

    B Braun is recalling the Infusomat Space Infusion Pump due to a sensor malfunction that can trigger false alarms, risking improper medication delivery.

    Product
    Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
    Category
    Medical Device
    Distribution
    6 states
  • 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