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 the agency’s own highest classification or reported deaths or serious injuries, 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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13151–13175 of 27500

  • HighFDA (Devices)·Z-2776-2020·2020-08-19

    Luminex Verigene Processor SP Recalled for Potential False Negative Results

    Luminex is recalling Verigene Processor SP systems because an instrument failure may cause false negative results in blood culture tests.

    Product
    Verigene Processor SP with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2793-2020·2020-08-19

    Brainlab Kick Navigation Station Recalled for Incorrect Calibration

    Brainlab AG is recalling 9 Kick navigation stations due to incorrect manufacturer calibration. The units were distributed in the US and internationally.

    Product
    BRAINLAB Kick 2; Model/catalogue (article) numbers for Kick: 18170; 18070 UDI (GTIN) for Kick: 04056481006655
    Category
    Medical Device
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-2734-2020·2020-08-12

    Smiths Medical Medfusion Syringe Pump Recall for Inaccurate Dose Delivery

    Smiths Medical is recalling Medfusion Syringe Pump Model 4000 units due to a risk of inaccurate drug delivery following interrupted bolus or loading doses.

    Product
    Medfusion Syringe Pump Model 4000; Software Versions V1.5.0, V1.5.1, V1.6.0, and V1.6.1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2716-2020·2020-08-12

    CareFusion Alaris System PC Unit Model 8000 Recall for Cleaning Agent Damage

    CareFusion 303, Inc. is recalling Alaris System PC Unit Model 8000 infusion pumps because cleaning agents may damage connectors, causing therapy interruptions.

    Product
    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2768-2020·2020-08-12

    Beacon EUS Access System Needle Recalled Due to Cannula Detachment

    Covidien is voluntarily recalling 375 units of the Beacon EUS Access System Preloaded Access 90-degree Needle because the cannula may detach during procedures.

    Product
    Beacon EUS Access System Preloaded Access 90degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2758-2020·2020-08-12

    Siemens Ysio Max X-Ray System Recalled for Software Defects

    Siemens Medical Solutions is recalling 512 Ysio Max X-ray systems due to software issues that may cause collisions or incorrect diagnostic images.

    Product
    SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2750-2020·2020-08-12

    GE Healthcare Recalls CARESCAPE ONE Monitors Due to Alarm Failure Risk

    GE Healthcare is recalling 8,414 CARESCAPE ONE patient monitors because they may fail to provide visual and audible alarms for Ventricular Fibrillation when docked to specific host monitors.

    Product
    CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2769-2020·2020-08-12

    Beacon EUS Access System Needle Recalled Due to Cannula Detachment

    Covidien is voluntarily recalling 269 Beacon EUS Access System needles because the cannula detached during procedures in three reported cases.

    Product
    Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2723-2020·2020-08-12

    CareFusion Alaris Auto ID Module Recall Due to Cleaning Agent Damage

    CareFusion is recalling Alaris Auto ID Modules because cleaning agents may damage connectors, causing infusion interruptions and therapy stops.

    Product
    Alaris Auto ID Module Model 8600, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2766-2020·2020-08-12

    Medline Recalls Endoscopic Cleaning Brushes Due to Detachment Risk

    Medline Industries Inc is recalling 1,400 endoscopic cleaning brushes because the brush may detach during use. The recall covers specific models and lots distributed nationwide.

    Product
    Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and pulled through the interior of the endoscope to remove…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2743-2020·2020-08-12

    Normand-Info Remisol Advance Software Recall for Erroneous Lab Results

    Normand-Info is recalling Remisol Advance software version 1.12 because it deletes specific white blood cell and platelet results, potentially leading to erroneous data.

    Product
    Remisol Advance running Software Version 1.12 The Normand Info Remisol Advance Data Manager collects and manages data and workflow for 128 connections (Beckman Coulter Instruments, automations, LIS &). It can also be connected to a host system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2759-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Failure

    Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2720-2020·2020-08-12

    CareFusion Alaris PCA Module 8120 Recalled for Cleaning Agent Damage

    CareFusion 303, Inc. is recalling 83,532 Alaris PCA Module Model 8120 units because cleaning agents may damage connectors, causing therapy interruptions.

    Product
    Alaris PCA Module Model 8120, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2755-2020·2020-08-12

    Siemens Luminos dRF Max Recalled for Software Collision and Image Errors

    Siemens is recalling 49 Luminos dRF Max units due to software defects that may cause system collisions or incorrect diagnostic images.

    Product
    SIEMENS Healthineers Luminos dRF Max Model: 10762471- Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2767-2020·2020-08-12

    Boss Instruments Recalls DeBakey Needle Holders Due to Plate Breakage Risk

    Boss Instruments is recalling 96 DeBakey needle holders because the tungsten carbide plate can break under pressure, posing a risk to patients and medical staff.

    Product
    BOSS DeBakey "Gator-Grip" Needle Holder 2 mm tip, 9", Part Numbers 50-2503 and 51-2503 - Product Usage: Endoscopic cleaning brushes are single use devices intended to clean the interior of endoscopes after endoscopy procedures. The brush is threaded through the biopsy valve and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2736-2020·2020-08-12

    CareFusion Alaris Pump Module Model 8100 Recalled for Broken Platen Elements

    CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units because broken platen elements can cause inaccurate fluid delivery, leading to over-infusion, free-flow, or under-infusion.

    Product
    Alaris Pump Module Model 8100
    Category
    Medical Device
    Distribution
    54 states
  • HighFDA (Devices)·Z-2748-2020·2020-08-12

    Teleflex Pleur-Evac Chest Drainage Devices Recalled for Packaging Risk

    Teleflex Medical Inc. is recalling Pleur-Evac chest drainage devices because sterile packaging may be compromised, potentially affecting sterility.

    Product
    Pleur-Evac Adult-Ped Wet, LF Intl Eng, product code: A-8000I - Product Usage: CHEST DRAINAGE: To evacuate air and/or fluid from the chest cavity or mediastinum. To help prevent air and/or fluid from re-accumulating in the chest cavity or mediastinum. To help re-establish and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2718-2020·2020-08-12

    CareFusion Alaris Pump Module 8100 Recalled for Cleaning Agent Damage

    CareFusion 303, Inc. is recalling Alaris Pump Module Model 8100 units because cleaning agents may damage connectors, causing therapy interruptions.

    Product
    Alaris Pump Module Model 8100, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2745-2020·2020-08-12

    Mako Hip End Effector Recalled for Potential Bone Preparation Discrepancy

    Mako Surgical Corporation is recalling 12 units of Mako Hip End Effectors due to a characterization issue that may cause discrepancies during bone preparation in certain Mako Total Hip procedures.

    Product
    Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-2719-2020·2020-08-12

    CareFusion Alaris Syringe Module Recall Due to Cleaning Agent Damage

    CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units because cleaning agents may damage connectors, potentially interrupting infusion therapy or monitoring.

    Product
    Alaris Syringe Module Model 8110, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2761-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect

    Boston Scientific is recalling Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially causing tissue damage or bleeding.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2722-2020·2020-08-12

    CareFusion Alaris SpO2 Modules Recalled for Cleaning-Related Connector Damage

    CareFusion 303, Inc. is recalling Alaris SpO2 Modules because cleaning agents may damage connectors, causing infusion or monitoring interruptions.

    Product
    Alaris SpO2 Module Model 8210 and Model 8220, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2740-2020·2020-08-12

    CareFusion Alaris System PC Unit Model 8000 Infusion Pump Recall

    CareFusion is recalling Alaris System PC Unit Model 8000 infusion pumps because loose or missing screws may cause power loss and therapy interruption.

    Product
    Alaris System PC Unit Model 8000 modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    55 states
  • HighFDA (Devices)·Z-2763-2020·2020-08-12

    Boston Scientific Recalls Captivator Polypectomy Snares Due to Cutting Defect

    Boston Scientific is recalling specific lots of Captivator Polypectomy Snares because they may fail to cut and remove polyps, potentially leading to prolonged procedures or tissue damage.

    Product
    Captivator Polypectomy Snare, Single-Use Polypectomy Snare consists of a flexible wire cable and loop which can be extended and retracted from the snare s flexible outer sheath using a three-ring handle. The inner diameter of the sheath is PolyGlide" Lubricant coated to provide…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2741-2020·2020-08-12

    CareFusion Alaris System PC Unit Model 8015 Infusion Pump Recall

    CareFusion is recalling Alaris System PC Unit Model 8015 infusion pumps because loose or missing screws may cause power loss and therapy interruption.

    Product
    Alaris System PC Unit Model 8015. modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    55 states