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.

Filters

Agency

Category

Minimum severity

Clear filters

10001–10025 of 40056

  • SevereFDA (Devices)·Z-1714-2023·2023-06-28

    Implantable Cardioverter Defibrillators Recalled for Potential Reduced Energy Output

    Medtronic implantable cardioverter defibrillators (ICDs) and CRT-Ds with specific feedthrough designs may produce reduced or insufficient energy during high voltage therapy, affecting the device's ability to treat heart arrhythmias.

    Product
    ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1761-2023·2023-06-28

    Implantable Defibrillators May Fail to Deliver Energy During Therapy

    Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy devices may fail to deliver adequate energy during high voltage therapy due to a feedthrough component defect. The rare condition could prevent the device from functioning when needed.

    Product
    CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1735-2023·2023-06-28

    Implantable defibrillators risk energy output failure during high voltage therapy

    Certain Medtronic cardiac defibrillators may produce reduced or no energy output during high voltage therapy. The defect involves a specific feedthrough component used in the manufacturing process.

    Product
    CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1726-2023·2023-06-28

    Medtronic ICD COBALT DR Potential Reduced Energy Output During Therapy

    Medtronic's ICD COBALT DR MRI defibrillators may fail to deliver high-voltage therapy due to a manufacturing defect in the device feedthrough. The rare potential affects 11,645 units distributed worldwide.

    Product
    ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1800-2023·2023-06-28

    Medtronic implantable defibrillators recalled for potential therapy delivery failure

    Medtronic's ICD and CRT-D devices may fail to deliver high-voltage therapy due to a defect in a specific feedthrough component. Patients should contact their healthcare provider immediately to discuss the risk.

    Product
    ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1989-2023·2023-06-28

    Single use hemostatic clips recalled for clip deployment and mechanical failures

    Olympus Corporation recalls QuickClip Pro hemostatic clips (13,707 units) nationwide due to device deployment failures. Complaints include clip arms failing to open or close and premature tissue detachment during clinical procedures.

    Product
    Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202UR.A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1982-2023·2023-06-28

    Medline TheraHoney Gel Wound Dressing Recalled for Sterilization Failure

    Medline is recalling 851,328 units of TheraHoney Gel wound dressing due to inadequate sterilization. The manufacturer failed to augment the sterilization dose after an audit failure, violating ISO 11137 standards.

    Product
    MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1984-2023·2023-06-28

    Masimo LNOP TC-I Pulse Oximeter Sensor May Produce Inaccurate Readings

    Masimo LNOP TC-I SpO2 reusable ear sensors may produce readings outside the manufacturer's accuracy specification. This Class II recall affects 86 units distributed across the US and multiple countries.

    Product
    Masimo LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1763-2023·2023-06-28

    Implantable Cardiac Defibrillators at Risk of Therapy Delivery Failure

    Medtronic implantable defibrillators may fail to deliver therapy due to a feedthrough defect. 2,173 affected units were distributed nationwide and worldwide.

    Product
    CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1991-2023·2023-06-28

    Karl Storz Sterilization Trays Recalled Due to Inadequate Instructions

    Karl Storz Endoscopy is recalling approximately 4,933 metal sterilization trays distributed worldwide. The trays were provided with instructions for use that were not specific to individual tray models regarding sterilization methods.

    Product
    Metal Tray, 178 x 135 x 37 mm, REF: 11580A; Metal Tray, 275 x 178 x 35 mm, REF: 11580B; Metal Tray, 373 x 178 x 35 mm, REF: 11580C; Metal Tray, 275 x 175 x 37 mm, REF: 11580D; Wire Tray f. Cleaning, 290x60x52mm, REF: 39501A1; Wire Tray f. Cleaning, 352 x 125 x 54 mm, REF…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1988-2023·2023-06-28

    Olympus QUICKCLIP PRO hemostatic clips recalled for deployment failures

    Olympus is recalling QUICKCLIP PRO hemostatic clips due to deployment failures that could prevent proper function during GI procedures. Clip arms may fail to operate or clips may detach prematurely from tissue.

    Product
    Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.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-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-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-1986-2023·2023-06-28

    Masimo Ear Oxygen Sensor Readings May Fall Outside Accuracy Specifications

    Masimo is recalling 123,745 reusable ear sensors that may produce inaccurate oxygen saturation readings. The affected devices were distributed throughout the US and 48 additional countries.

    Product
    Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1985-2023·2023-06-28

    Masimo SpO2 Ear Sensor May Produce Inaccurate Oxygen Saturation Readings

    Masimo LNCS TC-I SpO2 reusable ear sensors may produce readings outside their accuracy specifications. Approximately 443,799 units have been recalled due to a defect in the tip clip sensor affecting healthcare facilities in the US and over 50 countries.

    Product
    Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1718-2023·2023-06-28

    Medtronic Implantable Cardiac Defibrillators Risk Reduced Energy During Therapy

    Medtronic implantable cardiac defibrillators may deliver reduced or no energy during defibrillation therapy due to a feedthrough defect. Approximately 11,239 devices distributed worldwide are affected.

    Product
    ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1979-2023·2023-06-28

    Hemospray Endoscopic Hemostat Recalled for Powder Adhesion Risk

    Wilson-Cook Medical is recalling Hemospray Endoscopic Hemostat units (14,877 devices, US and worldwide distribution) because powder can adhere to the endoscope tip, potentially making removal difficult or impossible.

    Product
    Hemospray Endoscopic Hemostat: Reference Part Numbers: a) HEMO-10, REF G21049; b) HEMO-10-EU, REF G21346
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1975-2023·2023-06-28

    Serrated Blade Applicator Kit packaging may contain wrong applicator size

    Packaging for Helena Laboratories' Serrated Blade Applicator Kit (REF 552687) may contain the wrong applicator size (18-sample instead of 12-sample), causing incorrect or delayed diagnostic results in laboratory testing.

    Product
    Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
    Category
    Medical Device
    Distribution
    8 states
  • 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-1987-2023·2023-06-28

    Olympus QUICKCLIP PRO hemostatic clips recalled for deployment failures

    Olympus is recalling 340 QUICKCLIP PRO hemostatic clips used in gastrointestinal endoscopy due to reports of deployment failures during procedures, including clips that fail to open, close, or detach properly.

    Product
    Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostatic metal clip for the GI Tract Catalog Number: HX-202LR.A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1712-2023·2023-06-28

    Implantable Cardioverter Defibrillators Recalled for Rare Therapy Delivery Failure

    Certain Medtronic implantable defibrillators may fail to deliver high voltage therapy in rare cases due to a manufacturing defect. The recall affects approximately 61,404 units distributed worldwide.

    Product
    ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable Cardioverter Defibrillators
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2023·2023-06-28

    Implantable Defibrillators Recalled for Potential High-Voltage Therapy Failure

    Medtronic CRT-D and ICD devices with a specific feedthrough may fail to deliver high-voltage therapy. The FDA Class I recall affects multiple lot numbers due to rare potential for reduced or no energy output during critical treatment.

    Product
    CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; Implantable Cardioverter Defibrillators
    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