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

28101–28125 of 40233

  • HighFDA (Devices)·Z-0706-2017·2016-12-14

    Philips Spectral CT Software Recalled for Image Processing Defects

    Philips Medical Systems is recalling Spectral CT software due to a defect causing issues with filming, saving, and annotating images.

    Product
    Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0696-2017·2016-12-14

    Philips Ingenuity Core 128 MRI Software Recall for Timer Error

    Philips Medical Systems is recalling 509 Ingenuity Core 128 MRI systems due to a software error involving the filament on timer.

    Product
    Ingenuity Core 128 728323
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-0720-2017·2016-12-14

    RayStation 5.0 Radiation Therapy Software Recalled for Dose Display Error

    RaySearch Laboratories is recalling RayStation 5.0 software due to a potential error in dose display on auxiliary CT images, which could result in incorrect treatment planning data.

    Product
    Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0708-2017·2016-12-14

    Navilyst Recalls Xcela PICC Kits Due to Incorrect Glove Expiration Dates

    Navilyst Medical is recalling Xcela Power Injectable PICC Maximal Barrier Nursing Kits because included sterile gloves have incorrect expiration dates.

    Product
    Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0724-2017·2016-12-14

    Halyard C-Section Drapes Recalled for Manufacturing Variation

    Halyard Health is recalling specific lots of C-Section drapes because a manufacturing variation may prevent the removal of coated release paper, inhibiting easy access to the surgical site.

    Product
    Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Clear Screen and Full Incise (Sterile), Product Code 44966 00; C-Section Drape with Clear Screen (Non-Sterile), Product Code 44967 NS; C-Section Drape with Clear…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0714-2017·2016-12-14

    Angiodynamics Recalls PICC Catheters Due to Stylet Diameter Labeling Error

    Angiodynamics Inc. is recalling specific PICC catheters because the stylet diameter may differ from the label, potentially causing stiffening.

    Product
    Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0716-2017·2016-12-14

    Sorin Perceval Sutureless Aortic Heart Valve Field Action

    Sorin Group USA is conducting a voluntary field action for Perceval Sutureless Aortic Heart Valves due to updated implantation procedure steps.

    Product
    Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart Valve size L, Item # ICV1210, REF PVS25; Perceval Sutureless Aortic Heart Valve size XL, Item #…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0712-2017·2016-12-14

    DeRoyal Recalls PneuGel Tennis Elbow Supports Due to Mold Complaints

    DeRoyal Industries is recalling 56 units of PneuGel tennis elbow supports because of complaints regarding mold on the straps.

    Product
    TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0709-2017·2016-12-14

    BioFlo PICC Nursing Kits Recalled for Incorrect Glove Expiration Dates

    Navilyst is recalling BioFlo PICC Maximal Barrier Nursing Kits because the included sterile gloves have incorrect expiration dates.

    Product
    BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:5024787, 3) UPN # H965750141/Catalog No: 5024787, 4) UPN # H965750241/Catalog No: 5020644, 5) UPN # H965750325/Catalog No: 5026458, 6) UPN #…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0705-2017·2016-12-14

    Philips IQon Spectral CT Software Defect Recall

    Philips is recalling 24 IQon Spectral CT systems due to a software defect that causes issues with filming, saving, and annotating images.

    Product
    IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0717-2017·2016-12-14

    Ivoclar Vivadent Recalls Virtual XD Dental Impression Material

    Ivoclar Vivadent is recalling Virtual XD Refill Light Body Fast Set Wash Material because the dental impression material may fail to set up properly.

    Product
    Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0710-2017·2016-12-14

    BioFlo PICC Nursing Kits Recalled for Incorrect Glove Expiration Dates

    Angiodynamics is recalling BioFlo PICC Maximal Barrier Nursing Kits because included sterile gloves have incorrect expiration dates.

    Product
    BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0715-2017·2016-12-14

    Angiodynamics Recalls PICC Catheters Due to Stylet Diameter Labeling Error

    Angiodynamics is recalling PICC catheters because the stylet diameter may be larger than stated on the label.

    Product
    Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0698-2017·2016-12-14

    Elana Surgical KitHUD Recalled Due to Compromised Sterile Packaging Integrity

    Elana, Inc. is voluntarily removing four Elana Surgical KitHUD units because the sterile packaging of the included catheter may be compromised.

    Product
    Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0704-2017·2016-12-14

    Ultradent Recalls UltraSeal XT Plus Clear Refill Due to Labeling Error

    Ultradent Products, Inc. is recalling 31 units of UltraSeal XT Plus Clear Refill, Lot BD79T, because the package was mislabeled with an incorrect part number.

    Product
    UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0692-2017·2016-12-14

    Siemens Recalls SOMATOM Force CT Systems for Software Bugs

    Siemens is recalling 48 SOMATOM Force CT systems to install a software update that fixes bugs causing image errors and scan aborts.

    Product
    SOMATOM Force, System x-ray, tomography, computed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0726-2017·2016-12-14

    Merge PACS software recall for horizontal image cut lines

    Merge Healthcare is recalling Merge PACS software because image cut lines may appear horizontally instead of vertically.

    Product
    Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0718-2017·2016-12-14

    Ivoclar Vivadent Recalls Virtual XD Dental Impression Material Due to Setting Failures

    Ivoclar Vivadent is recalling Virtual XD Refill Light Body dental impression material because it may fail to set properly as it ages.

    Product
    Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0725-2017·2016-12-14

    Randox Magnesium IVD Reagent Recalled for Carryover Interference

    Randox Laboratories is recalling 15 units of Magnesium IVD reagents for the RX Imola analyser due to carryover interference from amylase tests.

    Product
    Magnesium on RX Imola analyser IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0700-2017·2016-12-14

    Medtronic Recalls Model 37751 Recharger for Spinal Cord Stimulation

    Medtronic is recalling Model 37751 Rechargers used for spinal cord stimulation because they may become unresponsive with a blank display and beeping sound.

    Product
    Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurostimulator. It includes a display to provide information on the charging system. The charging system consists of the Model 37751 Recharger…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0713-2017·2016-12-14

    DeRoyal Recalls Pneugel Tennis Elbow Straps Due to Mold Complaints

    DeRoyal Industries is recalling 791 units of Pneugel Tennis Elbow Straps because of complaints regarding mold on the product.

    Product
    PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0719-2017·2016-12-14

    Ivoclar Vivadent Recalls Virtual XD Dental Impression Material Due to Setting Failures

    Ivoclar Vivadent is recalling Virtual XD Test Pack dental impression material because it may fail to set properly as it ages.

    Product
    Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0711-2017·2016-12-14

    Encore Medical Recalls Mislabeled Empowr Knee Baseplate Implants

    Encore Medical is recalling seven Empowr Knee System baseplates that were mislabeled as size 6 but are actually size 4.

    Product
    Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0695-2017·2016-12-14

    Philips Ingenuity Core CT Systems Recalled for Software Error

    Philips Medical Systems is recalling 337 Ingenuity Core CT systems worldwide due to a software error involving the filament on timer.

    Product
    Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient…
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-0694-2017·2016-12-14

    Philips Brilliance 64 CT Systems Recalled for Software Error

    Philips Medical Systems is recalling 18 Brilliance 64 CT systems due to a software error involving the filament on timer.

    Product
    Brilliance 64 728232 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and…
    Category
    Medical Device
    Distribution
    46 states