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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28151–28175 of 40357

  • ModerateFDA (Devices)·Z-0770-2017·2016-12-21

    Natus neoBLUE blanket LED Phototherapy System Recalled for Fiber Optic Degradation

    Natus Medical is recalling neoBLUE blanket LED Phototherapy Systems due to discoloration and degradation of the fiberoptic bundle at the pad and box connection.

    Product
    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0748-2017·2016-12-21

    Ellman Minor Surgery Bipolar Cable Recalled for Mismatched Expiration Dates

    Ellman International is recalling 370 boxes of Minor Surgery Bipolar Cables because the expiration dates on the outer boxes and individual pouches do not match.

    Product
    ellman A CYNOSURE COMPANY Minor Surgery Bipolar Cable, Contents: Five (5) Disposable Bipolar Cables,STERILE The Minor Surgery Bipolar Cable is an accessory that is used to connect the bipolar handpieces to the RF generator for electrosurgical procedures that require the bipolar…
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-0768-2017·2016-12-21

    Beckman Coulter Recalls MicroScan LabPro Data Management System Software

    Beckman Coulter is recalling MicroScan LabPro Data Management System version 4.42 due to intermittent behavior that may delay reporting results.

    Product
    MicroScan LabPro Data Management System. Intended to manage both microbial identification (ID) and antimicrobial agent susceptibility testing (AST) data generated from MicroScan instruments or manually entered microbiology test results, for use by trained laboratory…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0730-2017·2016-12-21

    Merge Cardio software recall for data loss during inactivity

    Merge Healthcare is recalling Merge Cardio software versions 10.1 and 10.1.1 because the reporting feature times out after one hour of inactivity, causing data loss.

    Product
    Merge Cardio software. Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information from Camtronics and other vendors systems including images, hemodynamic studies and reports, measurements (via import from DICOM…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0758-2017·2016-12-21

    Halyard Health Recalls Sterling Nitrile Sterile Exam Gloves Due to Defects

    Halyard Health is recalling Sterling Nitrile Sterile Powder Free Exam Gloves because they may be discolored and brittle, causing them to tear when put on.

    Product
    Sterling Nitrile Sterile Powder Free Exam Gloves, S, Sterile.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0743-2017·2016-12-21

    Siemens SOMATOM Definition Flash CT Systems Recalled for Software Update

    Siemens is recalling 104 SOMATOM Definition Flash CT systems to install a software and firmware update that fixes bugs and improves performance.

    Product
    SOMATOM Definition Flash System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0735-2017·2016-12-21

    C.R. Bard Recalls 70cc Irrigation Syringes Due to Package Defect

    C.R. Bard is recalling 452,728 units of 70cc irrigation syringes because a package defect may compromise product sterility.

    Product
    BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap, Rx Only, Sterile, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0762-2017·2016-12-21

    Randox Liquid Cardiac Controls Recalled for Decreased Analyte Recovery

    Randox Laboratories is recalling Randox Liquid Cardiac Controls Level 1, 2, and 3 because internal stability monitoring revealed decreased recovery of myoglobin and CKMB.

    Product
    The Randox Liquid Cardiac Controls Level 1, Level 2, and Level 3 are liquid controls containing BNP, CK MB Mass, Digoxin, D-Dimer, Homocysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I, and Troponin T. They have been developed for use in the quality control of BNP, CK MB Mass…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0747-2017·2016-12-21

    PerkinElmer RoboRack Filter Tips Recalled for Inaccurate Liquid Handling

    PerkinElmer is recalling 595 trays of RoboRack filter tips because they may not seal properly, causing inaccurate liquid aspiration and dispensing in automated workstations.

    Product
    Perkin Elmer RoboRack 25ul, Clear, Non-Conductive, Filter Tips, Pre-sterilized Item Number: 6000689. Supplied for use with JANUS Automated Workstations: Product Number: AJS4001 AJM4001 AJI4001, AJL4001, AJS8001 , AJM8001, AJI8001, AJL8001, AJM4G01 , AJI4G01 , AJL4G01…
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0763-2017·2016-12-21

    Oculus Recalls Ceramax Skin Barrier Cream Professional Samples

    Oculus Innovative Sciences is recalling professional samples of Ceramax Skin Barrier Cream because they are not meeting stability standards.

    Product
    Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0736-2017·2016-12-21

    C.R. Bard Recalls 70cc Piston Syringes Due to Package Defect

    C.R. Bard is recalling 70cc Piston Syringes because a package slit defect may compromise product sterility.

    Product
    BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0754-2017·2016-12-21

    Olympus HF Cable WA00014A Recalled for Software Malfunction

    Olympus Corporation of the Americas is recalling 494 HF Cable WA00014A units due to a software malfunction that may cause incorrect error codes to be generated or displayed.

    Product
    HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0756-2017·2016-12-21

    Recall of Sterile Specimen Containers Due to Packaging Defect

    Covidien LLC is recalling 5,187,100 sterile specimen containers because a packaging defect compromised the sterility of the outer surface.

    Product
    Covidien Precision Specimen Container- 4 oz (118 mL), Plastic Screw Top Cap, OR Packaged, Sterile Item Code: 17099
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0737-2017·2016-12-21

    C.R. Bard Recalls Piston Syringes Due to Package Defect Risk

    C.R. Bard is recalling specific lots of 60cc Piston Syringes because a package slit defect may compromise product sterility.

    Product
    BARD¿ Piston Syringe, 60cc, Rx Only, Sterile, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are included. BARD¿…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0742-2017·2016-12-21

    Siemens SOMATOM Definition AS CT Systems Recalled for Software Bug Fixes

    Siemens Medical Solutions USA is recalling 104 SOMATOM Definition AS CT systems to install software and firmware updates that fix bugs and improve performance.

    Product
    SOMATOM Definition AS System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0741-2017·2016-12-21

    Cypress Medical Recalls McKesson Vinyl Exam Gloves for Leak Test Failure

    Cypress Medical Products is recalling McKesson Powder Free Vinyl Exam Gloves because a container failed the FDA leak test. The recall is limited to one distribution center in Auburn, Washington.

    Product
    McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116, 14-118, 14-120, 14-136, 14-138 and 14-140
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0744-2017·2016-12-21

    Siemens SOMATOM Definition Edge CT Systems Recalled for Software Bug Fixes

    Siemens Medical Solutions is recalling 104 SOMATOM Definition Edge CT systems to install a software update that fixes bugs and improves performance.

    Product
    SOMATOM Definition Edge System, x-ray, tomography, computed Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0749-2017·2016-12-21

    Ulthera Recalls Cellfina Prep Packs Due to Non-Sterile Vacuum Tube

    Ulthera Inc is recalling Cellfina Prep Packs because they contain a non-sterile vacuum tube, while the instructions describe using a sterile tube.

    Product
    Cellfina Prep Pack, Part No. CP1
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0738-2017·2016-12-21

    C.R. Bard Recalls BARDIA 60cc Piston Irrigation Syringes Due to Package Defect

    C.R. Bard is recalling BARDIA 60cc Piston Irrigation Syringes because a slit defect in the packaging may compromise product sterility.

    Product
    BARDIA¿ 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0740-2017·2016-12-21

    BD Recalls Spinal Anesthesia Trays Due to Incorrect Labeling

    Becton Dickinson is recalling 4,500 BD Spinal Anesthesia Trays because a small number were incorrectly labeled as Epidural Trays.

    Product
    BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anesthesia procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0769-2017·2016-12-21

    Natus neoBLUE Phototherapy Systems Recalled for Fiberoptic Pad Failure

    Natus Medical is recalling neoBLUE blanket LED Phototherapy Systems due to early failure of fiberoptic pads, which can cause discoloration and melting at the connector.

    Product
    Updated Natus neoBLUE blanket LED Phototherapy Systems. It provides phototherapy underneath the infant and can be used in a bassinet, open bed, radiant warmer, incubator, or while holding the infant. Affected systems including: 1) Updated light boxes (serial number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0757-2017·2016-12-21

    Pentax Ultrasound Video Bronchoscope Recalled for Incorrect Instructions

    Pentax of America Inc. is recalling 113 Ultrasound Video Bronchoscopes because they shipped with outdated instructions for use.

    Product
    Ultrasound Video Bronchoscope The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Track including but not restricted to organs, tissues, and subsystem: Nasal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0750-2017·2016-12-21

    Roche Recalls LightMix Zika rRT-PCR Test Due to False Positive Risk

    Roche Molecular Systems is recalling the LightMix Zika rRT-PCR Test because the software algorithm may occasionally report false positive results.

    Product
    LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0659-2017·2016-12-14

    SynCardia Freedom Driver System Recalled for Potential Silent Failure

    SynCardia Systems Inc. is recalling five Freedom Driver Systems because the main circuit board may fail silently, causing loss of life-sustaining function.

    Product
    5000 Series Freedom Drivers. Freedom Driver System for Temporary Total Artificial Heart (TAH-t). Part number 595000-001
    Category
    Medical Device
    Distribution
    2 states