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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34851–34875 of 40449

  • HighFDA (Devices)·Z-2609-2014·2014-09-17

    Ab Sciex API 3200MD System Recalled for Incorrect Diagnostic Data

    Ab Sciex is recalling six API 3200MD LC/MS/MS systems because the MultiQuant 3.0 software may provide incorrect data for patient diagnosis.

    Product
    AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In vitro diagnostic to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens Part Number 5024543.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2614-2014·2014-09-17

    Baxter Recalls Buretrol Solution Sets Due to Chamber Separation

    Baxter Healthcare is voluntarily recalling specific lots of Buretrol Solution Sets because the burette chamber may separate from the drip chamber.

    Product
    ***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip Chamber Filter Valve***3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile, Nonpyrogenic. ****Indications for Use: For the administration of fluids from a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2611-2014·2014-09-17

    Illumina Worklist Manager Software Recalled for Performance Failure

    Illumina Inc is recalling 35 units of Illumina Worklist Manager software v1.0.15 because it fails to perform as intended.

    Product
    Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2601-2014·2014-09-17

    Wright Medical Recalls CLAW II 2 Hole Plate OrthoLoc 3DSi Orthopedic Plates

    Wright Medical Technology is recalling 497 CLAW II 2 Hole Plate OrthoLoc 3DSi orthopedic plates because they were manufactured from an incorrect raw material.

    Product
    CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 15mm, REF 40240215, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2605-2014·2014-09-17

    Wright Medical Recalls CLAW II Straight Plate OrthoLoc 3DSi Orthopedic Devices

    Wright Medical Technology is recalling 66 units of CLAW II Straight Plate OrthoLoc 3DSi orthopedic devices because they were manufactured from an incorrect raw material.

    Product
    CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 20mm x 20mm, REF 40242020, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2603-2014·2014-09-17

    Wright Medical Recalls CLAW II Orthopedic Plates Due to Incorrect Material

    Wright Medical Technology is recalling 400 CLAW II 2 Hole Plate Ortholoc 3DSi units because they were manufactured from an incorrect raw material.

    Product
    CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 25mm, REF 40240225, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2610-2014·2014-09-17

    Ethicon Recalls PROXIMATE Skin Staplers Due to Unformed Staple Risk

    Ethicon Endo-Surgery Inc is recalling PROXIMATE skin staplers because a non-conforming component may cause the device to fire an unformed staple.

    Product
    PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bulk/Non-Sterile PROXIMATE RH Rotating-Head Skin Stapler (Model CK 117), and Bulk/Non-Sterile PROXIMATE PX Fixed-Head Skin Stapler (Model CK…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2604-2014·2014-09-17

    Wright Medical Recalls CLAW II Orthopedic Plates Due to Incorrect Raw Material

    Wright Medical Technology is recalling 178 CLAW II 2 Hole Plate Ortholoc 3DSi units because they were manufactured from an incorrect raw material.

    Product
    CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 30mm, REF 40240230, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2616-2014·2014-09-17

    Pioneer Surgical Technology Recalls Streamline MIS Spinal Fixation System Fixed Rod Holders

    Pioneer Surgical Technology is recalling nine Streamline MIS Spinal Fixation System Fixed Rod Holders because they failed to lock onto the spinal rod.

    Product
    Streamline MIS Spinal Fixation System Fixed Rod Holder NON STERILE, Rx only The Streamline MIS Spinal Fixation System is intended for posterior, noncervical pedicle fixation, T1-S2. Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2599-2014·2014-09-17

    Wright Medical Recalls Orthopedic Claw Plates Due to Incorrect Raw Material

    Wright Medical Technology is recalling specific orthopedic claw plates because they were manufactured from an incorrect raw material.

    Product
    CLAW PLATE 20mm INTERAXIS CHARLOTTE F&A SYSTEM, REF 40S20020, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2597-2014·2014-09-17

    Radiometer America Recalls RADIANCE Clinical Data Processing Software Versions 2.4X to 2.6X

    Radiometer America Inc. is voluntarily recalling RADIANCE software versions 2.4X, 2.5X, and 2.6X. The recall is classified as Class II by the FDA.

    Product
    RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2600-2014·2014-09-17

    Wright Medical Recalls 3.5mm Claw Plates Due to Incorrect Raw Material

    Wright Medical Technology is recalling 9 units of CLAW 3.5mm plates because they were manufactured from an incorrect raw material.

    Product
    CLAW 3.5mm PLATE CHARLOTTE F&A SYSTEM, SIZE 30mm, 2 HOLE, USE WITH 3.5mm CLAW SCREW, REF 4013-0130, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2625-2014·2014-09-17

    Life Force Chamber Recalled for Lack of FDA Approval

    Life Force of Tampa, LLC is recalling 10 Life Force Chambers because the product is marketed as a medical device without FDA premarket approval.

    Product
    Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2607-2014·2014-09-17

    Wright Medical Recalls CLAW II Straight Plate OrthoLoc 3DSi Orthopedic Plates

    Wright Medical Technology is recalling 18 units of CLAW II Straight Plate OrthoLoc 3DSi orthopedic plates because they were manufactured from an incorrect raw material.

    Product
    CLAW II STRAIGHT PLATE ORTHOLOC 3DSi, LENGTH 25mm x 25mm, REF 40242525, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2292-2014·2014-09-17

    Siemens Medical Imaging Systems Recalled for Potential Radiation Overexposure

    Siemens is recalling 192 Luminos dRF, Ysio, and Uroskop Omnia systems because a software malfunction may cause longer radiation exposure than required.

    Product
    Siemens Luminos dRF, Ysio or Uroskop Omnia systems. The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2615-2014·2014-09-17

    Baxter Recalls Buretrol Solution Sets Due to Chamber Separation

    Baxter Healthcare is voluntarily recalling specific lots of Buretrol Solution Sets because the burette chamber may separate from the drip chamber.

    Product
    ***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***Drip Chamber Filter Valve 3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile, Nonpyrogenic.***Indications for Use: For the administration of fluids from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2623-2014·2014-09-17

    Medtronic Recalls Hancock Apical Left Ventricle Connectors Due to Production Discontinuation

    Medtronic is recalling two units of the Hancock Apical Left Ventricle Connector because the company has decided to discontinue production and distribution of this low-volume product.

    Product
    Hancock Apical Left Ventricle Connector, Model No. H174Axx, Catalog No. 0174ACP012. Used use in conjunction with Hancock Conduit Model 105 to provide an alternate method for relief of left ventricular hypertension.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2613-2014·2014-09-17

    Baxter Recalls Buretrol Solution Sets Due to Chamber Separation

    Baxter Healthcare is voluntarily recalling specific lots of Buretrol Solution Sets because the burette chamber may separate from the drip chamber.

    Product
    ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Valve***3 Injection Sites Male Luer Lock Adapter with***Retractable Collar***Fluid path is Sterile, Nonpyrogenic***Indications for Use: For the administration of fluids from a container into…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2624-2014·2014-09-17

    Integra Container Lids Recalled for Lack of FDA Clearance

    Integra York PA, Inc. is recalling 84 container lids that were distributed without FDA clearance.

    Product
    Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Gold; Container Lid, ¿¿ Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2602-2014·2014-09-17

    Wright Medical Recalls CLAW II Orthopedic Plates Due to Material Error

    Wright Medical Technology is recalling 1,127 CLAW II 2 Hole Plate Ortholoc 3DSi units because they were manufactured from an incorrect raw material.

    Product
    CLAW II 2 HOLE PLATE ORTHOLOC 3DSi, LENGTH 20mm, REF 40240220, 1 EACH, Rx ONLY, NON STERILE Orthopedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2618-2014·2014-09-17

    BD MAX MRSA Assay Recalled for False Positive Results

    Becton Dickinson is recalling 585,048 BD MAX MRSA Assay tests because some samples yielded false positive results during CAP surveys.

    Product
    The BD MAX MRSA Assay, catalogue #442953. An automated qualitative in vitro diagnostic test for the direct detection of Methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patie.
    Category
    Medical Device
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-2596-2014·2014-09-17

    Primus Medical Recalls Transcend and Bariatric Mattresses Due to Delamination

    Primus Medical LLC is recalling specific Transcend and Bariatric mattresses because the top cover is delaminating. The recall affects 1,557 units distributed in the US and Canada.

    Product
    Prime Care ¿ Transcend Mattress, Prime Care ¿ Transcend Perimeter Mattress, Prime Care ¿ Transcend Advanced Mattress, Prime Care ¿ Transcend Advanced Perimeter Mattress, Prime Plus ¿ Bariatric Mattress and Prime Plus ¿ Bariatric Perimeter Mattress, individual units packaged…
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-2598-2014·2014-09-17

    Merci Retriever Medical Devices Recalled for Expiration Date Issues

    Concentric Medical Inc is recalling nine Merci Retriever devices shipped past their expiration date. The devices were labeled with the correct expiration date but distributed to US customers after that date.

    Product
    Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the…
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2570-2014·2014-09-17

    CooperSurgical H/S Catheter Recalled Due to Unsealed Pouches

    CooperSurgical is recalling 1,400 H/S Catheters intended for hysterosonography because some pouches were unsealed.

    Product
    CooperSurgical H/S CATHETER (PART # 61-5007) Intended for Hysterosonography/ Hysterosalpingography.
    Category
    Medical Device
    Distribution
    18 states
  • ModerateFDA (Devices)·Z-2595-2014·2014-09-17

    Catheter Connections Recalls DualCap IV Pole Strips Due to Packaging Seal Defect

    Catheter Connections is recalling DualCap IV Pole Strips disinfectant caps because a packaging defect may compromise sterility. The recall affects 24,910 units distributed in four states.

    Product
    DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap Solo" disinfects needleless luer access valves; thereafter the caps provide a physical barrier to contamination up to ninety-six (96) hours…
    Category
    Medical Device
    Distribution
    4 states