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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23176–23200 of 27663

  • HighFDA (Devices)·Z-2078-2015·2015-07-22

    Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization

    Sorin Group USA is recalling 283 Sorin Stockert Heater-Cooler 3T units due to potential colonization of organisms, including Mycobacteria, if proper disinfection is not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2095-2015·2015-07-22

    Alere i Influenza A & B Kit Recalled for False Negative Risk

    Alere is recalling 257 kits of the Alere i Influenza A & B test due to microbial growth that may cause false negative results.

    Product
    Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B assay, performed on the Alere" i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2084-2015·2015-07-22

    NDI Disposable Reflective Marker Spheres Recalled for Adhesive Defect

    Northern Digital Inc. is recalling NDI Disposable Reflective Marker Spheres because inadequate adhesive curing may cause the spheres to separate.

    Product
    NDI Disposable Reflective Marker Spheres for Brainlab IGS (Image Guided Surgical) system. Product Usage: Disposable reflective marker spheres are attached to reference arrays and instruments, thus enabling the infrared tracking systems to detect the position of the patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2092-2015·2015-07-22

    Synthes Recalls RIA Drive Shafts and Reamer Heads Due to Breakage Risk

    Synthes, Inc. is recalling Reamer / Irrigator / Aspirator (RIA) components because they may break if incorrectly assembled or used improperly.

    Product
    Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2080-2015·2015-07-22

    Sorin Heater-Cooler Devices Recalled for Potential Microbial Colonization

    Sorin Group USA is recalling Stockert Heater-Cooler 3T devices due to the potential for microbial colonization, including Mycobacteria, if proper disinfection and maintenance are not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1951-2015·2015-07-15

    Shiley Pediatric Tracheostomy Tubes Recalled for Breathing Difficulties

    FDA recalls Shiley tracheostomy tubes due to reports of patient discomfort and breathing difficulties.

    Product
    Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1989-2015·2015-07-15

    Alliance Partners Recalls Nakoma-SL Cervical Plating Drill Guides

    Alliance Partners LLC is recalling 21 Nakoma-SL Anterior Cervical Plating System drill guides because screws may advance through the plate during implantation.

    Product
    Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2046-2015·2015-07-15

    Biomet Recalls A.L.P.S. Foot Locking Calcaneus Plates Due to Thread Defects

    Biomet is recalling 75 A.L.P.S. Foot Locking Calcaneus Plates because thread defects may cause screws to back out or shear, potentially requiring revision surgery.

    Product
    A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.
    Category
    Medical Device
    Distribution
    10 states
  • SevereFDA (Devices)·Z-1950-2015·2015-07-15

    Shiley Neonatal and Pediatric Tracheostomy Tubes Recalled for Breathing Difficulties

    FDA is recalling Shiley Neonatal and Pediatric Tracheostomy Tubes because patients reported discomfort and breathing difficulties after switching to these products.

    Product
    Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. Model Numbers…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1990-2015·2015-07-15

    Maquet Surgical Light Suspension Arms Recalled for Debris Risk

    Maquet is recalling 646 PowerLED, X-TEN, and VOLISTA surgical light systems because suspension arms may grind and release paint chips into the surgical field.

    Product
    The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems typically include one or more arms that are able to rotate 360 degrees around…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1987-2015·2015-07-15

    Philips GoSafe Communicator 7000L Personal Emergency Response System Recall

    Lifeline Systems is recalling 38 Philips GoSafe Communicator 7000L units because they may fail to sense the phone line under unusual landline conditions.

    Product
    Philips GoSafe Communicator 7000L Personal emergency response system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1986-2015·2015-07-15

    BTE Technologies Recalls Primus Exercise Devices Due to Detachment Risk

    BTE Technologies is recalling 510 Primus rehabilitation devices because the optional Chop / Lift Bar may detach, posing a fall hazard to users.

    Product
    Primus (THE BTE WS30), model PrimusRS (PRRS) and Primus+ (PR30) a measuring exercise equipment device designed to provide active and passive torque resistance to patient motion during rehabilitation therapy. The Primus that includes the optional Chop / Lift Bar.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2034-2015·2015-07-15

    Stradis Pediatric Pack Recalled Due to Medtronic Component Recall

    Stradis Healthcare is recalling Pediatric Packs containing Devon Light Gloves due to a manufacturer recall of the glove component by Medtronic.

    Product
    Pediatric Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1993-2015·2015-07-15

    Stradis Basic Pack Recalled Due to Medtronic Component Recall

    Stradis Healthcare is recalling Basic Packs containing Devon Light Gloves because the manufacturer, Medtronic, is recalling the glove component.

    Product
    Basic Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2041-2015·2015-07-15

    Stradis Arthroscopy Packs Recalled Due to Component Recall

    Stradis Healthcare is recalling Arthroscopy Packs because they contain Devon Light Gloves, which are being recalled by the manufacturer Medtronic.

    Product
    Arthroscopy Pack - contains Devon Light Glove Used during surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2045-2015·2015-07-15

    Volcano ComboMap Intravascular System Recalled for Interoperability Limitation

    Volcano Corp is recalling 227 ComboMap Intravascular Flow and Pressure Systems due to a limitation in interoperability with the Philips Xper Flex Cardia Physiomonitoring System.

    Product
    ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map - 802745-001. Intravascular Imaging and Pressure System for evaluation of blood flow, perfusion and vascular structures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1902-2015·2015-07-08

    FDA Recalls Palindrome Precision HSI Chronic Catheter Kits for Antimicrobial Issues

    The FDA is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1917-2015·2015-07-08

    HeartWare Ventricular Assist System Recalled for Power Switching Issues

    HeartWare Inc. is recalling HVAD systems due to abnormal power source switching. The device is used as a bridge to cardiac transplantation.

    Product
    HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac transplantation in patient who are at risk of death from refractory end-stage left ventricular heart failure.
    Category
    Medical Device
    Distribution
    32 states
  • SevereFDA (Devices)·Z-1897-2015·2015-07-08

    Palindrome Precision HSI Chronic Catheter Kit Recalled for Antimicrobial Defect

    Covidien LLC is recalling Palindrome Precision HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888145057CP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1904-2015·2015-07-08

    Palindrome HSI Chronic Catheters Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome HSI Chronic Catheters because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 units internationally.

    Product
    Palindrome HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1888-2015·2015-07-08

    Recall of Palindrome Precision SI Chronic Catheters Due to Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome Precision SI Chronic Catheters because they may not meet antimicrobial specifications. The recall covers 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133508P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1867-2015·2015-07-08

    Palindrome SI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome SI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects units with expiry dates of February 2018 and earlier.

    Product
    Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1894-2015·2015-07-08

    Palindrome HSI Chronic Catheter Kit Recalled for Antimicrobial Specification Failure

    Covidien LLC is recalling Palindrome HSI Chronic Catheter Kits because they may not meet antimicrobial specifications. The recall affects 72,363 units in the US and 24,631 internationally.

    Product
    Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050
    Category
    Medical Device
    Distribution
    Distributed nationwide