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

25051–25075 of 27686

  • HighFDA (Devices)·Z-1643-2014·2014-05-28

    Gambro Polyflux Revaclear Dialyzers Recalled for Internal Blood Leaks

    Gambro Renal Products is recalling Polyflux Revaclear capillary dialyzers due to reports of internal blood leaks.

    Product
    Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1624-2014·2014-05-28

    Hospira Recalls T-U-R Y-Sets Due to Potential Sterile Package Seal Defect

    Hospira is recalling specific T-U-R Y-Sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.

    Product
    LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira Product Usage: For use in transurethral resection procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1626-2014·2014-05-28

    Hospira Recalls Large Bore Y-Irrigation Sets Due to Packaging Seal Defect

    Hospira is recalling specific lots of Large Bore Y-Irrigation Sets because the Tyvek cover may not be completely sealed, potentially compromising the sterile package.

    Product
    LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; single use; Hospira Product Usage: For Use With Flexible Irrigation Container Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1640-2014·2014-05-28

    GE Healthcare Recalls NeuroMuscular Transmission Modules for Inaccurate Readings

    GE Healthcare is recalling 1,794 NeuroMuscular Transmission Modules because they may display inaccurate muscle relaxation levels when used with ElectroSensors.

    Product
    GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1646-2014·2014-05-28

    Philips XIRIS 8.1.50.0 Recall Due to Patient Data Synchronization Error

    Philips Healthcare Informatics is recalling 5 units of XIRIS 8.1.50.0 due to a synchronization error that may display incorrect patient information.

    Product
    Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1635-2014·2014-05-28

    Microline Renew Fenestrated Control Tip Grasper Recalled for Jaw Breakage

    Microline Surgical is recalling 540 units of Renew Fenestrated Control Tip Graspers because the jaw may break when force is applied.

    Product
    Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1650-2014·2014-05-28

    Smiths Medical Recalls Snuggle Warm Sterile Cardiac Warming Blankets

    Smiths Medical ASD, Inc. is recalling 2,120 Snuggle Warm Sterile Cardiac Connective Warming Blankets because the hose could separate from the blanket.

    Product
    SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regulation of a patient's temperture and are designed to prevent hypothermia and/ or reduce cold discomfort during and after surgical procedures.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1627-2014·2014-05-28

    Hospira Recalls Latex-Free 4-Lead T-U-R Irrigation Sets Due to Sealing Defect

    Hospira Inc. is recalling 29,380 Latex-Free 4-Lead T-U-R Irrigation Sets because the Tyvek cover may not be completely sealed, potentially compromising sterility.

    Product
    LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Systems; List No. 15239-01; Single Use; Hospira Product Usage: For Transurethral Resection Procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1647-2014·2014-05-28

    Siemens Recalls Dimension Vista Cyclosporine Test Kits Due to Under-Recovery

    Siemens Healthcare Diagnostics is recalling Dimension Vista CSA and CSAE test kits because they may under-recover cyclosporine levels when using Small Sample Containers.

    Product
    Dimension Vista¿ CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista¿ System. Measurements of CSA are used as an aid in the management of heart, liver and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1651-2014·2014-05-28

    Heraeus Kulzer Recalls Gluma Desensitizer Power Gel Due to Extrusion Risk

    Heraeus Kulzer is recalling Gluma Desensitizer Power Gel because it may extrude all at once, causing irritation, burning, or blistering to patients or dental professionals.

    Product
    Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1649-2014·2014-05-28

    Medline Esmark Elastic Bandages Recalled for Sterilization Failure

    Medline Industries is recalling 2,860 Esmark Elastic Bandages because they may not have been properly sterilized.

    Product
    Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case. Packaged by Medline Industries Inc. This product is used as an elastic bandage to support and compress a part of a patient's body. It is also used as a tourniquet to restrict…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1566-2014·2014-05-21

    Baxter ABACUS TPN Calculation Software Recalled for Calculation Errors

    Baxter Corporation is recalling ABACUS TPN Calculation Software because it may calculate incorrect electrolyte quantities and display inaccurate data.

    Product
    ABACUS TPN Calculation Software, Product Codes: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition), 8300-0156 ABACUS 3.0 CE, 8300-0157 ABACUS 3.0 SE, 8300-0158 ABACUS 3.0 ME, 8300-0166…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1619-2014·2014-05-21

    Fresenius Hemodialysis Machine Test Boards Recalled for Pump Detection Failure

    Fresenius Medical Care is recalling Revision K Actuator Test Boards for 2008-Series Hemodialysis Machines because they may fail to detect a disconnected Ultrafiltration Pump.

    Product
    Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1567-2014·2014-05-21

    CareFusion Recalls Alaris Pump 8100 Due to Software Delay Issue

    CareFusion is recalling Alaris Pump model 8100 units with specific software versions because a defect may prevent the pump from properly delaying infusions.

    Product
    Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1577-2014·2014-05-21

    Newport Medical e360 Ventilator Component Recalled for Audible Alarm Failure

    Nellcor Puritan Bennett is recalling 5,765 single board computer components for the Newport Medical e360 Ventilator because the audible alarm may not sound during alarm states.

    Product
    Recalled product is a component of the Newport Medical Instruments e360 Ventilator: single board computer, part number SBC2105A. Intended to provide invasive or noninvasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure…
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1612-2014·2014-05-21

    Medline Mucus Specimen Traps Recalled for Potential Sterility Issues

    Medline Industries is recalling 1,610 mucus specimen traps because they may not be sterile, which could contaminate patient specimens.

    Product
    Mucus Specimen Trap 40 cc, Specimen Trap 40 cc with additional transport cap; Product number DYND44140 (pack of 50), Product number DYND44140H (individual). Mucus Specimen Trap 80 cc, Specimen Trap 80 cc w/ additional transport cap; Product number DYND44180 (pack of 50).…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1573-2014·2014-05-21

    SCC Soft Computer Recalls SoftMic Laboratory Information System Software

    SCC Soft Computer is recalling SoftMic version 4.0.7.0 because missing SNOMED codes may cause incomplete patient data and delayed treatment updates.

    Product
    SCC SA HIS version 4.0.7.0 when used with SoftMic version 4.0.7.0. SoftMic is a laboratory information system to be used in medical results, clinical, and public health laboratories by knowledgeable, trained, and experienced personnel. SoftMic enables the user to handle data…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1616-2014·2014-05-21

    Roche Recalls ACCU-CHEK Compact Plus Test Strips Due to Ceftriaxone Interference

    Roche is recalling ACCU-CHEK Compact Plus test strips because they may produce erroneously low blood glucose readings in patients taking Ceftriaxone.

    Product
    ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count retail strip; 51 count MedBen strip 51 count Mail Order strip; Sample Kit 16 per case. The ACCU-CHEK Compact Plus Test Strips are for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1609-2014·2014-05-21

    FDA Recalls Defective Ultrasound Needles That May Leak at Hub

    RM Temena GmbH is recalling ultrasound needles that may leak at the hub. The recall involves 7,370 needles distributed in the US.

    Product
    Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under ultrasound guidance
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1608-2014·2014-05-21

    FDA Recalls Defective Ultrasound Needles That May Leak at Hub

    RM Temena GmbH is recalling 7,370 ultrasound needles that may leak at the needle hub. The defective needles were distributed in Maryland and Illinois.

    Product
    Ultrasound needles, 22G (0.7 mm) x 50mm, packaged individually, 10 needles/box, item number REF USC050-22. Needles for peripheral nerve blocking under ultrasound guidance.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1606-2014·2014-05-21

    Zimmer Recalls Neoprene Tennis Elbow Supports Due to Latex Contamination

    Zimmer, Inc. is recalling 649 units of Neoprene Tennis Elbow Supports because raw material labeled as latex-free actually contained latex.

    Product
    Tennis Elbow Support, Neoprene***LATEX FREE" Product Usage: Provides compression and warmth for mild to moderate elbow strains and sprains.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1615-2014·2014-05-21

    Biomet ExploR Radial Stem Recalled for Missing Threads

    Biomet is recalling eight ExploR 7x26mm Modular Radial Stem implants because missing wedge ramp threads may cause set screw loosening, potentially requiring revision surgery.

    Product
    ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1605-2014·2014-05-21

    Zimmer Hinged Knee Support Recalled Due to Latex Contamination

    Zimmer, Inc. is recalling 546 units of Hinged Knee Supports because raw material labeled as latex-free actually contained latex.

    Product
    Hinged Knee Support***LATEX FREE" Product Usage: Provide added lateral stability and allows the knee to tolerate more strenuous activity during recuperation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1604-2014·2014-05-21

    Zimmer Cartilage Knee Brace Recalled Due to Latex Contamination

    Zimmer, Inc. is recalling 2,222 units of Cartilage Knee Braces because raw material labeled as latex-free actually contained latex.

    Product
    Cartilage Knee Brace***LATEX FREE" Product Usage: Used in the treatment and support of many types of knee injuries or following surgical and nonsurgical correction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1613-2014·2014-05-21

    Siemens Syngo Dynamics PACS Recalled for Patient Demographics Display Error

    Siemens Medical Solutions is recalling 50 Syngo Dynamics v9.5 systems due to a software error that may cause incorrect patient demographics to be displayed.

    Product
    Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation.
    Category
    Medical Device
    Distribution
    Distributed nationwide