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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24226–24250 of 40299

  • HighFDA (Devices)·Z-1403-2018·2018-04-25

    Teleflex Medical One Way Valve Recall for Potential Disconnection

    Teleflex Medical is recalling specific lots of HUDSON RCI One Way Valves because they may disconnect, causing an interruption of ventilation to patients.

    Product
    Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1408-2018·2018-04-25

    Philips Brilliance iCT CT Systems Recalled for Emergency Stop Defect

    Philips is recalling 295 Brilliance iCT CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient loading.

    Product
    Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1385-2018·2018-04-25

    Datascope Mega Intra-Aortic Balloon Catheter Recalled for Missing Contraindications

    Datascope is recalling Mega Intra-Aortic Balloon Catheters because the U.S. Instructions for Use were missing the Contraindications section.

    Product
    Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1422-2018·2018-04-25

    Carefusion Recalls Jamshidi Needle Biopsy Devices Due to Packaging Integrity Concerns

    Carefusion 2200 Inc is recalling 790 units of Jamshidi Needle Biopsy devices because the integrity of the sterile packaging is potentially compromised.

    Product
    JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1416-2018·2018-04-25

    Terumo HX2 Temperature Management System Recall for Updated Cleaning Instructions

    Terumo is recalling HX2 Temperature Management Systems to update cooler-heater cleaning instructions. The recall affects 2,393 units distributed worldwide.

    Product
    Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1375-2018·2018-04-25

    Wright Medical VALOR Nail Recall for Missing Compression Screw

    Wright Medical Technology is recalling 47 units of VALOR Nails that may be missing an assembled compression screw.

    Product
    WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1444-2018·2018-04-25

    TMJ Solutions Recalls Misidentified Right Mandibular Component

    TMJ Solutions Inc is recalling a specific right mandibular component of a TMJ Reconstruction Prosthesis System because it was mislabeled and is not the correct component for the intended patient.

    Product
    Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1390-2018·2018-04-25

    NAMIC Fluid Management Convenience Kits Recalled for Assembly Defect

    Angiodynamics Inc. is recalling 38 NAMIC Fluid Management Convenience Kits because the Fluid Delivery Set was not assembled to specification, preventing device use.

    Product
    Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1394-2018·2018-04-25

    GE Healthcare Lunar DPX Bone Density Systems Recalled for Data Errors

    GE Healthcare is recalling 43 Lunar DPX bone density systems because patient reports may be sent to hospital systems with incorrect names in the header.

    Product
    GE Healthcare Lunar: a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369 b) DPX MD+, Model Numbers: LU8230, LU40338, LU40352 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1383-2018·2018-04-25

    Datascope Mega Intra-Aortic Balloon Catheter Recalled for Missing Contraindications

    Datascope is recalling 2,714 Mega Intra-Aortic Balloon Catheters because the U.S. Instructions for Use are missing the Contraindications section.

    Product
    Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1393-2018·2018-04-25

    GE Healthcare Lunar DPX Duo and Bravo Bone Density Software Recall

    GE Healthcare is recalling Lunar DPX Duo and Bravo bone density scanners because a software issue may cause reports to be filed under the wrong patient name in the hospital system.

    Product
    GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1376-2018·2018-04-25

    Wright Medical VALOR Nail Recall for Missing Compression Screw

    Wright Medical Technology is recalling VALOR Nails that may be missing an assembled compression screw.

    Product
    WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Small, OD: 11.5mm, L: 150mm, REF415101115R
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1418-2018·2018-04-25

    Terumo Sarns TCM II Recall for Updated Cleaning Instructions

    Terumo is recalling Sarns TCM II devices to update cleaning instructions. The recall covers 2,393 units distributed worldwide.

    Product
    Sarns TCM II, Catalog Numbers: 4415; 4416;164925; 164930;164935;164940 UDI 00886799000014 The Sarns TCM is indicated for controlling and monitoring patient temperature .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1384-2018·2018-04-25

    Datascope Mega Intra-Aortic Balloon Catheter Recalled for Missing Contraindications

    Datascope is recalling 655 Mega Intra-Aortic Balloon Catheters because the U.S. Instructions For Use were missing the Contraindications section.

    Product
    Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1387-2018·2018-04-25

    Preservation Solutions Recalls Cold Storage Solution Bags Due to Leaks

    Preservation Solutions, Inc. is recalling 31,104 units of Cold Storage Solution bags due to potential leaks at the injection port.

    Product
    Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002. Intended for the hypothermic flushing and storage of specific organs in preparation for storage, transportation, and…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1392-2018·2018-04-25

    Philips Ingenuity TF PET/CT Recalled for Unresponsive Acquisition Console

    Philips is recalling 12 Ingenuity TF PET/CT systems because the mass storage device may cause the acquisition console to become unresponsive, preventing image acquisition.

    Product
    Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) system suitable for a wide range of diagnostic applications. The device utilizes the CT technology to obtain…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1417-2018·2018-04-25

    Terumo Sarns TCM Recall for Updated Cooler-Heater Cleaning Instructions

    Terumo is recalling Sarns TCM devices to update cleaning instructions for the cooler-heater component.

    Product
    Sarns TCM, Catalog No. 15747 The Sarns TCM is indicated for controlling and monitoring patient temperature .
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1395-2018·2018-04-25

    GE Healthcare Prodigy Ultrasound Recall for Incorrect Patient Data in Reports

    GE Healthcare is recalling Prodigy and Prodigy Advanced ultrasound systems because bone density exam reports may be sent to PACS with incorrect patient information in the DICOM header.

    Product
    GE Healthcare: a) Prodigy, Model Numbers: LU7248, LU8905, LU40427, LU40431, LU40626, LU40637, LU40626, LU40637, LU42021, LU42025, LU41730, LU41734, LU42344, LU42365 b) Prodigy Advanced, Model Numbers: LU42361, LU42397 Provides an estimate of BMD (Bone Marrow Density) at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1443-2018·2018-04-25

    Keystone Dental Recalls Stage-1 Tissue Punches Due to Damaged Cutting Edges

    Keystone Dental Inc is recalling 101 Stage-1 Tissue Punches because the cutting edges may have small dents and nicks.

    Product
    Stage-1 Tissue Punch, Disposable, 4.5mm; catalog number: ISS141K. Intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1419-2018·2018-04-25

    OraSure Cocaine Metabolite Test Kit Recalled for False Positive Results

    OraSure Technologies is recalling 10 units of Cocaine Metabolite MICRO-PLATE EIA kits because controls may cause false positive results.

    Product
    Cocaine Metabolite MICRO-PLATE EIA, Catalog Number: 1122SC, UDI: (0100608337000429(17)180228(10)000
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-1386-2018·2018-04-25

    Southern Implants Recalls Dental Implants Due to Inner Labeling Error

    Southern Implants is recalling 49 dental implant units because the inner label incorrectly identifies the product reference number.

    Product
    SOUTHERN IMPLANTS REF IBR12d-13, Implant, Ext. Hex, tapered 12o Co-Axis(TM) intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1365-2018·2018-04-18

    Fresenius Liberty Select Cycler Recalled for Software Overfill Risk

    Fresenius Medical Care is recalling Liberty Select Cyclers due to a software issue that may cause overfill, posing a risk of serious injury or death.

    Product
    Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1351-2018·2018-04-18

    W & H DentalWerk Recalls S-N1 and S-N2 Foot Controls

    W & H DentalWerk is recalling S-N1 and S-N2 foot controls because they may fail to stop the motor, posing a risk of serious patient injury.

    Product
    Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1314-2018·2018-04-18

    Terumo Cardiovascular Procedure Kits Recalled for Potential Blood Leaks

    Terumo is recalling 2,677 Cardiovascular Procedure Kits containing Pall LG6NS filters due to a risk of blood leaks through the hydrophobic portion.

    Product
    Terumo Cardiovascular Procedure Kits containing Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filters. The Cardiovascular Procedure Kit containing the Pall LG6NS LeukoGuard¿ Leukocyte Reduction Arterial Blood Filter for Exh¿acorporeal Service is indicated for use…
    Category
    Medical Device
    Distribution
    7 states
  • SevereFDA (Devices)·Z-1318-2018·2018-04-18

    Reliance Medical Products Recalls Refractor Suspension Arms Due to Missing Parts

    Reliance Medical Products is recalling 933 Refractor Suspension Arms because missing parts caused the device to fall on a patient.

    Product
    Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended use of this medical device, as part of system to store and position ophthalmological examination and diagnostic equipment, is to store and position for examination a device commonly known as a…
    Category
    Medical Device
    Distribution
    Distributed nationwide