The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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5851–5875 of 40007

  • SevereFDA (Devices)·Z-3083-2024·2024-09-25

    Baxter EXACTAMIX pharmaceutical compounding inlets recalled for particulate contamination

    Baxter Healthcare Corporation is recalling EXACTAMIX Inlet components due to particulate matter found in sterile fluid path tubing. Approximately 1.5 million units were distributed worldwide.

    Product
    Baxter EXACTAMIX Inlet, Vented, High Volume Inlet, REF H938174, for use in a pharmaceutical compounding device
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3174-2024·2024-09-25

    Hemodialysis tubing may fail to flow if connector is incompletely inserted

    B Braun's STREAMLINE FRESENIUS bloodline tubing used in hemodialysis may have a design issue where incomplete insertion of the patient connector prevents proper blood flow during certain procedures. Patients receiving dialysis may experience treatment delays.

    Product
    STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095D
    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-3143-2024·2024-09-25

    Seer Home EEG System Recalled for EMC Non-Compliance

    Seer Home System ambulatory EEG devices were recalled due to electromagnetic compatibility non-compliance and manufacturing control deficiencies. The issue may affect signal recording reliability in home EEG monitoring.

    Product
    Seer Home System is an ambulatory electroencephalograph (EEG) system intended for at-home use for extended EEG and video EEG (vEEG) recordings and analysis. The Seer Home System includes the Sight Monitoring Hub, the Sense wearable, Monitoring Portal and associated accessory comp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3182-2024·2024-09-25

    HAWK Advanced Hypothermia Management Set recalled for incorrect expiration dates

    Safeguard US Operating LLC is recalling the HAWK Advanced Hypothermia Management Set due to incorrect expiration dates on affected units. The product may not perform reliably if used after the incorrect date.

    Product
    HAWK Advanced Hypothermia Management Set, Item Number: 59-320
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3172-2024·2024-09-25

    Smith & Nephew K-Wire Surgical Device Recall for Packaging Error

    Smith & Nephew is recalling K-Wire surgical devices due to a packaging error that resulted in wrong-sized wires being distributed. Healthcare providers may have received incorrectly sized bone fixation fasteners affecting approximately 73 units.

    Product
    DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-3177-2024·2024-09-25

    Hemodialysis tubing connector may not fully insert, risking flow occlusion

    B. Braun Medical is recalling STREAMLINE LONG hemodialysis bloodline tubing because the patient connector may fail to fully insert into the Locksite, potentially causing blood flow obstruction during dialysis treatment.

    Product
    STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2000M2095W
    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-3150-2024·2024-09-25

    Sump Catheter System Recalled for Potential Sterile Barrier Defect

    Boston Scientific is recalling the vanSonnenberg Sump Catheter System Kit because the sterile barrier pouch may have holes that could compromise device sterility. The recall affects 4 units distributed in the US, Colombia, Philippines, and Russia.

    Product
    vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously placed drain for intra-abdominal fluid collections.
    Category
    Medical Device
    Distribution
    0 states
  • 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 (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-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-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-3179-2024·2024-09-25

    B Braun Streamline Bloodline Set Recalled for Potential Occlusion

    B Braun Medical Inc. is recalling Streamline Bloodline Sets because incomplete connector insertion may cause flow restrictions during hemodialysis.

    Product
    STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood between a patient and a haemodialyser during haemodialysis. Model/Catalog Number: SL-2010M2096A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3167-2024·2024-09-25

    PHILIPS INTEGRIS X-ray systems cable hose carrier detachment recall

    PHILIPS medical X-ray imaging systems may have a cable hose carrier that can detach due to broken plastic or bolts, potentially causing parts to fall and injure clinical staff.

    Product
    System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris Allura 9 722017 Integris H5000 F / Allura 9F 722016 Integris H5000 C / Allura 9C
    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-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-3171-2024·2024-09-25

    K-Wire Packaging Error Recall by Smith & Nephew

    Smith & Nephew issued a voluntary recall of K-Wire bone fixation fasteners due to a packaging error where packages contained the wrong wire diameter than labeled.

    Product
    DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
    Category
    Medical Device
    Distribution
    0 states
  • 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-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-3148-2024·2024-09-25

    Flexima Biliary Catheter System Kits recalled for potential sterile barrier failure

    Boston Scientific is recalling Flexima Biliary Catheter System Kit (Lot #33512376) due to potential holes in the device pouch's sterile barrier, which could compromise device sterility. No illnesses or injuries have been reported.

    Product
    Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail
    Category
    Medical Device
    Distribution
    0 states
  • 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-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-1157-2024·2024-09-25

    Medline Contro-Bulb Syringe Recalled for Potential Sterile Barrier Breach

    Medline is recalling 4,831 Contro-Bulb Syringes due to potential sterile barrier breach during transportation. The recall affects two lot numbers and applies nationwide.

    Product
    Medline Contro-Bulb Syringe, REF DYND20125; bulb irrigation syringe
    Category
    Medical Device
    Distribution
    Distributed nationwide