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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36501–36525 of 40449

  • SevereFDA (Devices)·Z-0908-2014·2014-02-12

    Medtronic Mosaic Aortic Obturator Recalled for High Transvalvular Gradients

    Medtronic is recalling Mosaic Aortic Obturators used with Mosaic Porcine Aortic Bioprostheses due to higher-than-expected transvalvular gradients after implant.

    Product
    Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0918-2014·2014-02-12

    Edwards Lifesciences Recalls 26mm Transcatheter Heart Valve Crimpers

    Edwards Lifesciences is recalling two lots of 26mm transcatheter heart valve crimpers because they may not open fully, potentially preventing proper valve preparation.

    Product
    Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0931-2014·2014-02-12

    CareFusion Recalls Trifurcated Extension Sets Due to Potential Component Leak

    CareFusion 303, Inc. is recalling Trifurcated Extension Sets (models ME 1224 and MP 9230) because a defect in the trifurcated component could result in a leak.

    Product
    Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0937-2014·2014-02-12

    ITC-Nexus Dx Recalls Hemochron Jr. Citrate APTT Cuvettes for Inaccurate Results

    ITC-Nexus Dx is recalling Hemochron Jr. Citrate APTT Cuvettes because they may produce higher than expected results in normal individuals.

    Product
    Hemochron Jr. Citrate APTT Cuvette 510(k) K014008 A unitized microcoagulation test intended to be used in performing a quantitative, one -stage APTT. The citrate APTT test is used for evaluation of low doses of heparin anticoagulant (up to 1.5 units/mL), depending upon…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0926-2014·2014-02-12

    ArjoHuntleigh Rotoprone Therapy System Recalled for Lock Pin Malfunction

    ArjoHuntleigh is recalling 231 Rotoprone Therapy Systems because a lock pin can become stuck, preventing patients from being positioned prone.

    Product
    The Rotoprone therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications. The Rotoprone Therapy System provides up to 62 degrees in both prone and supine positions as well as Trendelenburg/Reverse Trendelenburg positioning.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0927-2014·2014-02-12

    GE Healthcare Recalls CARESCAPE Monitor B850 Due to Communication Loss

    GE Healthcare is recalling 12,945 CARESCAPE Monitor B850 units worldwide because the F5-01 Frame may lose communication with the patient monitor.

    Product
    CARESCAPE Monitor B850, a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. Product Usage: The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0925-2014·2014-02-12

    CareFusion Recalls SmartSite Needleless Connectors Due to Connection Issues

    CareFusion is recalling SmartSite Needleless Connectors because they may unintentionally disconnect, be difficult to disconnect, or fail to disconnect from a female luer.

    Product
    SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0917-2014·2014-02-12

    GE Healthcare Recalls Infant Resuscitation T-Piece Upgrade Kits

    GE Healthcare is recalling 561 infant resuscitation T-piece upgrade kits because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture.

    Product
    Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0915-2014·2014-02-12

    GE Healthcare Recalls Infant Resuscitation Units Due to Loose Adjustment Knob

    GE Healthcare is recalling 48 Stand-Alone Resuscitation Units because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.

    Product
    Stand-Alone Resuscitation Unit, Bag and Mask, Upgrade Kits, part number M1139612, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infant.s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0929-2014·2014-02-12

    Siemens Recalls ADVIA Centaur Phenytoin Calibrator Due to Recovery Changes

    Siemens Healthcare Diagnostics is recalling specific lots of ADVIA Centaur Phenytoin Calibrator N because a change in recovery was observed compared to previous lots.

    Product
    ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0936-2014·2014-02-12

    Ossur Recalls Symbionic Leg Prostheses Due to Electronics Defect

    Ossur is recalling 17 Symbionic Leg prostheses due to a possible defect in a small batch of electronics. The recall affects units distributed in seven US states and DC.

    Product
    The Symbionic Leg is an integrated prosthetic leg for transfemoral and knee disarticulation amputees. The prosthesis is composed of the RHEO KNEE and the PROPRIO FOOT, both already existing products from ¿ssur. Both are a battery powered micro-processor controlled prosthetic…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0914-2014·2014-02-12

    GE Healthcare Recalls Infant Resuscitation Units Due to Loose Adjustment Knob

    GE Healthcare is recalling 15 infant resuscitation units because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture.

    Product
    Stand-Alone Resuscitation Unit, Bag and Mask, part number M1226444, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com***. Provides the basic equipment required for pulmonary resuscitation of infants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0913-2014·2014-02-12

    GE Healthcare Panda Infant Warmers Recalled for Loose Adjustment Knob

    GE Healthcare is recalling Panda iRes and Freestanding Infant Warmers because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.

    Product
    Panda iRes¿ Infant Warmers, part number M1112198 and Panda Freestanding Warmers, part number 2063568, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com** Panda Infant Warmers provide infrared heat in a controlled manner to neonates who…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0921-2014·2014-02-12

    B. Braun AccuFlo Elastomeric Infusion Pump Recalled for Flow Rate Issues

    B. Braun Medical is recalling AccuFlo Elastomeric Infusion Pumps because internal testing found flow rates outside specifications, which may cause overly rapid medication infusion.

    Product
    B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML Generally used for delivery of antibiotic and local anesthesia medications.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0928-2014·2014-02-12

    Elekta XiO RTP System Recalled for Incorrect Effective Depth Calculation

    Elekta, Inc. is recalling 1,424 XiO RTP Systems because the software may calculate incorrect Effective Depth values when bolus is present.

    Product
    XiO RTP System. Used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0911-2014·2014-02-12

    GE Healthcare Recalls X-ray Systems Due to Monitor Suspension Nut Issue

    GE Healthcare is recalling Precision 500D, MPI, and RXI X-ray systems because a locking nut on the overhead monitor suspension may loosen.

    Product
    GE Healthcare Precision 500D, Precision MPI & Precision RXI X-ray imaging systems. The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0912-2014·2014-02-12

    GE Healthcare Recalls Giraffe Infant Warmers Due to Loose Adjustment Knob

    GE Healthcare is recalling 1,970 Giraffe Infant Warmers because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.

    Product
    Giraffe¿ Infant Warmers, part number M1118179, labeled in part *** GE Healthcare 8880 Gorman Road Laurel, MD 20723***www.gehealthcare.com* Giraffe¿ Infant Warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0916-2014·2014-02-12

    GE Healthcare Recalls Stand-Alone Resuscitation T-Pieces Due to Loose Knob

    GE Healthcare is recalling 375 Stand-Alone Resuscitation T-Pieces because a loose adjustment knob may affect the accuracy of the blended Air/Oxygen gas mixture delivered to patients.

    Product
    Stand-Alone Resuscitation, T-Piece, part numbers 2063771-001, 2063772-001, 2063773-001, 2063774-001, 2063775-001, M1226442, M1241420, M1241421, M1241424, M1241425, M1241427, M1241430, M1241461, M1241463, M1241464, and M1241589; labeled in part ***GE Healthcare 8880 Gorman Road…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0907-2014·2014-02-12

    Siemens SOMATOM CT Systems Recalled for Potential Display Freeze Malfunction

    Siemens Medical Solutions is recalling 147 SOMATOM CT systems due to a potential display freeze malfunction during clinical operation.

    Product
    Siemens SOMATOM Definition, Definition AS, Definition Flash, and Definition Edge systems. X-ray tomography, computed, radiology.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0920-2014·2014-02-12

    Fresenius Bicarbonate Jug Adapter Recalled for Premature Distribution

    Fresenius Medical Care is recalling 703 Bicarbonate Jug Adapters distributed before receiving FDA 510(k) approval.

    Product
    Fresenius Bicarbonate Jug Adapter to the 2008 Series Hemodialysis machine Part Number: 650103. The adapter is a socket that accepts the 2008 machine spike to draw concentrate from the container.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0930-2014·2014-02-12

    Siemens Recalls ADVIA Centaur Phenytoin Calibrator Due to Recovery Changes

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Phenytoin Calibrator N lots due to observed changes in assay recovery.

    Product
    ADVIA Centaur¿ Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic use in the quantitative determination of phenytoin in serum or plasma using the ADVIA Centaur and ADVIA Centaur XP systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0932-2014·2014-02-12

    Philips Diagnostic Imaging Systems Recalled for Database Lockup

    Philips Medical Systems is recalling 386 diagnostic imaging systems because the PET Reconstruction Server database may randomly lock up, preventing PET acquisitions and resulting in incomplete studies.

    Product
    Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model #882438, GEMINI TF PET/CT16 Model #882470, GEMINI TF PET/CT 64 Model #882471, GEMINI TF Ready Model #882473 & GEMINI TF Big Bore Model #882476)
    Category
    Medical Device
    Distribution
    35 states
  • ModerateFDA (Devices)·Z-0935-2014·2014-02-12

    Zest Anchors Recalls Locator Implant Attachment Systems Due to Labeling Error

    Zest Anchors is voluntarily recalling specific lots of Locator Implant Attachment Systems because the product labels incorrectly state the final torque for the abutment.

    Product
    LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0903-2014·2014-02-12

    Stryker Neptune 2 Rover Ultra Waste Management System Field Upgrade

    Stryker is upgrading Neptune 2 Rover Ultra Waste Management Systems in the field to meet new 510(k) clearance specifications.

    Product
    Neptune 2 Rover Ultra Waste Management System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0933-2014·2014-02-12

    Stryker Recalls Gaymar Medi-Therm Devices Due to Missing Water Temperature Display

    Stryker is recalling 1,002 Gaymar Medi-Therm devices because the water temperature display is blank in Auto mode, potentially preventing users from verifying water temperature.

    Product
    The Gaymar Medi-Therm device provides a means of regulating patient temperature by supplying temperature-controlled water through a connector hose to accessory Gaymar Hyper/Hypothermia blanket(s)/body wrap(s). The blanket/body wrap provides an interface for heating or cooling…
    Category
    Medical Device
    Distribution
    Distributed nationwide