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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9251–9275 of 13731

  • HighFDA (Devices)·Z-1978-2023·2023-06-28

    Hemospray Endoscopic Hemostat Recall Due to Endoscope Adhesion Risk

    Wilson-Cook Medical's Hemospray Endoscopic Hemostat is being recalled because the powder can adhere to the endoscope, potentially making it difficult to remove the instrument from the patient.

    Product
    Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-7, REF G56572; b) HEMO-7-EU, REF G24663;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1990-2023·2023-06-28

    Hemostatic Clip Device Recalled Due to Deployment Failures

    Olympus recalls QUICKCLIP PRO hemostatic clips nationwide due to reported malfunction during clinical procedures, where clips fail to open, close, or detach from tissue as intended.

    Product
    Single Use Repositionable Clip QUICKCLIP PRO 230CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1992-2023·2023-06-28

    Draeger Resuscitaire Warmer Scale May Display Inaccurate Weight Values

    Draeger Medical Systems is recalling 936 units of Softbed Resuscitaire and Birthing Room Warmer models with optional scales that may display inaccurate weight readings, affecting clinical care for newborns.

    Product
    Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1 and WBR82-1C]
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1983-2023·2023-06-28

    Masimo RD Set TC-I SpO2 Adult Ear Sensor Recalled for Inaccurate Readings

    Masimo Corporation is recalling 138,926 units of the RD Set TC-I SpO2 Adult Reusable Ear Sensor because the tip clip sensor may produce readings outside the manufacturer's accuracy specification.

    Product
    Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor, REF: 4053
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1976-2023·2023-06-28

    NextSeq 550Dx sequencing instruments recalled for cybersecurity software vulnerability

    Illumina is recalling 1,067 NextSeq 550Dx sequencing instruments due to a cybersecurity vulnerability in the Universal Copy Service software. The affected instruments have been distributed worldwide.

    Product
    NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1754-2023·2023-06-28

    Implantable Cardiac Defibrillators May Deliver Reduced Energy Output

    Certain Medtronic cardiac defibrillators may deliver reduced or no energy during high voltage therapy. No injuries or deaths have been reported.

    Product
    CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1981-2023·2023-06-28

    KARL STORZ sterilization trays recalled for inadequate model-specific instructions

    FDA recalls KARL STORZ sterilization trays (4,386 units) because instructions lacked model-specific details and sterilization modality information, risking improper device sterilization.

    Product
    KARL STORZ Radel Sterilization Trays, Models: 27717A, 27717B, 39301A, 39301C, 39231XA, 39301C1, 39311A, 39317A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1993-2023·2023-06-28

    HeartWare Ventricular Assist Device Monitor logfile processing failure

    Heartware, Inc. is recalling 19 HeartWare Ventricular Assist Device System monitors (Model 1521 variants) because recently updated units cannot process downloaded logfiles in the Autologs web portal.

    Product
    HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1980-2023·2023-06-28

    V-Sign Sensor 2 May Experience Out-of-Box Failure Due to Software Configuration

    The V-Sign Sensor 2, a component of the Sentec Digital Monitoring System, may fail out of the box due to improper software mode configuration after recalibration. Approximately 11 units were distributed in select U.S. states.

    Product
    V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring System (model SDMS).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1977-2023·2023-06-28

    FDA Recalls MiSeq Dx Instruments for Software Cybersecurity Vulnerability

    Illumina recalls 740 MiSeq Dx sequencing instruments due to a software cybersecurity vulnerability affecting the Universal Copy Service component. No patient harm reported.

    Product
    MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1667-2023·2023-06-21

    Nitric Oxide Delivery System check valve misalignment risk

    NOxBOXi Nitric Oxide Delivery System devices may malfunction due to misaligned check valves, risking gas leaks and therapy interruption. This could lead to oxygen desaturation if the device fails during patient use.

    Product
    NOxBOXi Nitric Oxide Delivery System, NOXBOX-I, REQNOXBOX-I, Nitric Oxide Delivery Device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1693-2023·2023-06-21

    p-Chip Wand Reader Recalled for Laser Classification Safety Issue

    FDA is recalling 329 p-Chip Wand Reader units due to laser operation potentially exceeding its classified safety level. Affected models are WA-4000, WA-4500, WA-8000, and WA-8500 distributed nationwide.

    Product
    p-Chip Wand Reader
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1913-2023·2023-06-21

    Aspira Pleural Drainage Catheter May Fail to Drain Fluid

    Merit Medical Systems is recalling 524 units of the Aspira Pleural Drainage Catheter Insertion Tray due to a defect where valve assemblies may not open, preventing fluid drainage. Affected units were distributed worldwide including across the US, France, UK, and Mexico.

    Product
    Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507, Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2023·2023-06-21

    Medicine Dropper Recalled for Potential Glass Particulate Contamination

    Apothecary Products, LLC is recalling 1,596 units of Medicine Dropper (Lot 021623) due to potential glass particles on the dropper bulb exterior. Glass particles could contaminate medication or cause injury.

    Product
    Medicine Dropper, Product Code K508
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1915-2023·2023-06-21

    Aspira Pleural Drainage Catheter Insertion Tray recalled due to valve failure

    Merit Medical Systems recalls the Aspira Pleural Drainage Catheter Insertion Tray due to a potential valve failure that could prevent fluid drainage. The recall affects approximately 1054 units distributed nationwide and internationally.

    Product
    Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1910-2023·2023-06-21

    Aspira Peritoneal Drainage Catheter Insertion Tray valve malfunction

    Merit Medical's Aspira Peritoneal Drainage Catheter Insertion Tray valve assemblies may fail to open, preventing fluid drainage. 175 units distributed nationwide and internationally are affected.

    Product
    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1911-2023·2023-06-21

    Merit Medical Peritoneal Drainage Catheter Insertion Tray Recalled for Valve Failure

    Merit Medical Systems is recalling Aspira Peritoneal Drainage Catheter Insertion Trays because valve assemblies may fail to open, potentially preventing proper fluid drainage in affected lots.

    Product
    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1966-2023·2023-06-21

    bellavista 1000 Ventilator Recalled for Software Hang and Use Error Risk

    Vyaire Medical is recalling approximately 910 units of the bellavista 1000 Ventilator due to a software issue that can cause the touchscreen to become unresponsive and a potential use error risk if operators do not confirm settings are appropriate for the patient.

    Product
    bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1972-2023·2023-06-21

    Driver Instrument May Break During Surgery, Leaving Metal Fragments

    The Superion Indirect Decompression System's driver instrument may fracture during implantation if excessive force is applied, potentially leaving metal fragments in the surgical site. Retained fragments contraindicate MRI scans.

    Product
    Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1916-2023·2023-06-21

    Aspira Valve Repair Kit may fail to open and obstruct fluid drainage

    Merit Medical Systems is recalling Aspira Valve Repair Kits because valve assemblies may fail to open, preventing fluid drainage. The FDA Class II recall affects 2,559 units distributed across the US and internationally.

    Product
    Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1824-2023·2023-06-21

    External Fixation System Post Component Recall Due to Thread Stripping

    New Standard Device Inc is recalling 222 units of 'n'-Hole Posts used in the Revolution External Fixation System because the threads strip out during tensioning, potentially compromising fracture fixation.

    Product
    'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1969-2023·2023-06-21

    Tearaway Introducer Set Recall Due to Potential Luer Connection Failure

    Galt Medical Corporation is recalling Tearaway Introducer Sets due to potential cracks or dislodgement of the luer connection during use. The defect, linked to improper storage conditions, could render the device unusable.

    Product
    Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1920-2023·2023-06-21

    Aspira Drainage Catheter Insertion Tray valve assembly may fail to open

    Merit Medical Systems is recalling certain Aspira Drainage Catheter Insertion Trays (Model 15.5F) due to a potential valve assembly defect that could prevent fluid drainage. No injuries have been reported.

    Product
    Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1912-2023·2023-06-21

    Aspira Pleural Drainage Catheter Insertion Tray recalled for valve assembly malfunction

    Merit Medical Systems is recalling the Aspira Pleural Drainage Catheter Insertion Tray because valve assemblies may not open, preventing proper fluid drainage.

    Product
    Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1702-2023·2023-06-21

    Eye and Ear Dropper Recalled for Potential Glass Particulate Contamination

    Apothecary Products is recalling Eye and Ear Droppers (Product Code 67082) due to the potential for glass particulate on the dropper bulb's external surface. Consumers should stop using affected units immediately.

    Product
    Eye and Ear Dropper, Product Code 67082
    Category
    Medical Device
    Distribution
    Distributed nationwide