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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20301–20325 of 40287

  • HighFDA (Devices)·Z-1860-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling 11 VOLISTA StandOP Surgical Lights because light head fork coatings may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1887-2019·2019-07-03

    AtriCure EPi-Sense Guided Coagulation System Recalled for Compromised Sterile Seal

    AtriCure is recalling 497 units of the EPi-Sense Guided Coagulation System because the sterile package seal may be compromised, posing a risk of infection.

    Product
    EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Product Usage: The EPi-Sense Guided Coagulation System with VisiTrax, consists of a sterile, single-use, disposable coagulation electrode device (1cm, 2cm, and 3cm sizes provided) intended to be used to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1885-2019·2019-07-03

    GE Healthcare Recalls Centricity PACS-IW Universal Viewer Software

    GE Healthcare is recalling Centricity PACS-IW with Universal Viewer version 5.0 because medical images may be missing without warning.

    Product
    Centricity PACS-IW with Universal Viewer version 5.0, Model Number 2068177-001 Product Usage: Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1853-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling 11 VOLISTA StandOP Surgical Lights because coating on the light head forks may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1878-2019·2019-07-03

    GE Healthcare Recalls ECG Leadwire Sets Due to Defibrillation Risk

    GE Healthcare is recalling specific ECG leadwire sets because they may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.

    Product
    Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in 2106381-002 ECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 in 2106381-003 ECG Leadwire set, 5-lead, snap, IEC, 74 cm/ 29 in 2106381-004 ECG Leadwire…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1857-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling two VOLISTA StandOP Surgical Lights because the light head coating may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1873-2019·2019-07-03

    Thermo Scientific General Purpose Dynamic Bath Recalled for Assembly Error

    Thermo Fisher Scientific is recalling two Thermo Scientific General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to rise above the user's set point.

    Product
    Thermo Scientific General Purpose Dynamic Bath Precision 5L GP Bath Model Number: TSGP05
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1858-2019·2019-07-03

    Maquet VOLISTA Surgical Lights Recalled for Coating Crack Risk

    Maquet is recalling six VOLISTA StandOP Surgical Lights because the coating on the light head forks may crack, posing a risk of particles falling into the surgical field.

    Product
    Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1866-2019·2019-07-03

    Thermo Fisher Isotemp Water Bath Recalled for Assembly Error

    Thermo Fisher Scientific is recalling five Isotemp 10L General Purpose Water Baths due to an assembly error that may cause the fluid temperature to rise above the set point.

    Product
    Fisher Scientific Isotemp -General Purpose Water Bath: lsotemp 10L GP Bath Model Number: FSGPD10
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1868-2019·2019-07-03

    Thermo Scientific General Purpose Dynamic Bath Recalled for Assembly Error

    Thermo Fisher Scientific is recalling 12 General Purpose Dynamic Bath units due to an assembly error that may cause the fluid temperature to exceed the user's set point.

    Product
    Thermo Scientific General Purpose Dynamic Bath Precision 10L GP Bath Model Number: TSGP10
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1890-2019·2019-07-03

    Ethicon ENSEAL X1 Curved Jaw Tissue Sealer Recalled for Bleeding Risk

    Ethicon Endo-Surgery Inc is recalling ENSEAL X1 Curved Jaw Tissue Sealers due to reported intraoperative bleeding.

    Product
    Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1882-2019·2019-07-03

    Medtronic Hancock II Mitral Bioprosthesis Recalled for Incorrect Size Labeling

    Medtronic is recalling 15 Hancock II T510 Mitral Bioprosthesis valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.

    Product
    Hancock II T510 Bioprosthesis, Mitral, REF T505U227 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1884-2019·2019-07-03

    Medtronic Hancock II T510 Bioprosthesis Recalled for Incorrect Size Labeling

    Medtronic is recalling 15 Hancock II T510 Bioprosthesis mitral valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.

    Product
    Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1880-2019·2019-07-03

    Medtronic Mosaic 310 Bioprosthesis Recalled for Incorrect Size Labeling

    Medtronic is recalling 15 Mosaic 310 Bioprosthesis mitral valves because they were mislabeled with incorrect sizes. The actual valves are larger than indicated on the packaging.

    Product
    Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1891-2019·2019-07-03

    Qiagen RNeasy DSP FFPE Kit Recalled Due to Contaminant

    Qiagen is recalling 31 units of the RNeasy DSP FFPE Kit because a contaminant in the deparaffinization solution reduces RNA purification efficiency.

    Product
    RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is a system intended for the purification of total RNA from formalin-fixed, paraffin embedded (FFPE) tissues. The product is intended to be used by professional users, such as technicians and physicians…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1881-2019·2019-07-03

    Medtronic Mosaic 310 Bioprosthesis Recalled for Incorrect Size Labeling

    Medtronic is recalling 15 Mosaic 310 Bioprosthesis mitral valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.

    Product
    Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1851-2019·2019-07-03

    Tecan Freedom EVO 200 Laboratory Robots Recalled for Gas Spring Maintenance

    Tecan US, Inc. is recalling 40 Freedom EVO 200 laboratory robots because gas springs were not always replaced within the specified interval.

    Product
    Freedom EVO 200 - Product Usage: It is intended for routine laboratory tasks, such as general purpose pipetting and general purpose liquid handling and robotic processes.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1883-2019·2019-07-03

    Medtronic Hancock II T510 Bioprosthesis Recalled for Incorrect Size Labeling

    Medtronic is recalling 15 Hancock II T510 Bioprosthesis valves because they were mislabeled with an incorrect size. The actual valves are larger than indicated on the packaging.

    Product
    Hancock II T510 Bioprosthesis, Mitral, REF T510C27 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1875-2019·2019-07-03

    GE Healthcare Recalls ECG Trunk Cables Due to Defibrillation Risk

    GE Healthcare is recalling ECG trunk cables that may reduce energy delivery during defibrillation, potentially limiting the success of the procedure.

    Product
    ECG Trunk Cables: REF/Catalog Number Description 2106305-001 ECG Trunk Cable, 3/5-lead, AHA, 3.6 m/12 ft. 2106305-002 ECG Trunk Cable, 3/5-lead, AHA, 1.2 m/4 ft. 2106305-003 ECG Trunk Cable, 3/5-lead, IEC, 3.6 m/12 ft. 2106305-004 ECG Trunk Cable, 3/5-lead, IEC, 1.2 m/4…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1759-2019·2019-06-26

    Teleflex Recalls Sheridan LTS Tracheal Tubes Due to Connector Disconnection

    Teleflex Medical is voluntarily recalling specific lots of Sheridan LTS tracheal tubes because the 15 mm connector may disconnect from the tube.

    Product
    Hudson RCI Sheridan LTS, Product Code 5-11112 Product Usage: Tracheal tube/airway management
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1757-2019·2019-06-26

    Cook Inc. Recalls Advance Enforcer 35 Focal Force PTA Balloon Catheters

    Cook Inc. is recalling 131 Advance Enforcer 35 Focal Force PTA Balloon Catheters because multiple complaints reported the balloons bursting below their rated pressure.

    Product
    Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1786-2019·2019-06-26

    Monarch EndoTool IV Software Recalled for High Insulin Dosing Calculations

    Monarch Medical Technologies is recalling EndoTool IV software versions 1.8 through 1.10 because insulin dosing calculations were erroneously high.

    Product
    Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1750-2019·2019-06-26

    GE Healthcare Recalls Discovery ML DR PET/CT Systems Due to Table Stop Defect

    GE Healthcare is recalling 1,113 Discovery ML DR PET/CT systems because the table may stop moving without stopping X-ray exposure.

    Product
    Discovery Ml DR Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1749-2019·2019-06-26

    GE Healthcare Recalls Discovery ML PET/CT Systems Due to X-Ray Safety Defect

    GE Healthcare is recalling 1,113 Discovery ML PET/CT systems because the table may stop moving without stopping X-ray exposure.

    Product
    Discovery Ml Product Usage: The systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1766-2019·2019-06-26

    Teleflex Recalls Sheridan Novaplus Endotracheal Tubes Due to Connector Disconnection

    Teleflex Medical is voluntarily recalling specific lots of Sheridan Novaplus endotracheal tubes because the 15 mm Sheridan connector may disconnect from the tube.

    Product
    Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V5-10315 3) Novaplus 8.0 mm, Product Code V5-10316 4) Novaplus 8.5 mm, Product Code V5-10317 Product Usage: Tracheal tube/airway management
    Category
    Medical Device
    Distribution
    Distributed nationwide