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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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

28176–28200 of 40357

  • SevereFDA (Devices)·Z-0699-2017·2016-12-14

    Tornier Recalls Aequalis Fx2 Shoulder Implant Parts Due to Dislocation Reports

    Tornier is recalling Aequalis Fx2 implant parts and instrument trays due to reports of poly insert and stem dislocations.

    Product
    Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0647-2017·2016-12-14

    Centurion Multi-Med Single Lumen Catheters Recalled for Embolism Risk

    Centurion Medical Products is recalling 1,000 Multi-Med Single Lumen Catheter kits because excess material at the catheter tip may separate and cause an embolism.

    Product
    Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, and central venous pressure monitoring.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0702-2017·2016-12-14

    Thayer MANOS EX Surgical Device Recalled for Missing Safety Warning

    Thayer Intellectual Property, Inc. is recalling 339 MANOS EX surgical devices because customers were not notified of a critical safety warning regarding device bending and breakage.

    Product
    MANOS EX (CAT#TY-12-101) Product Usage: Carpal Tunnel Release: as a tool for tissue release of the transverse carpal ligament in patients with Carpal Tunnel Syndrome who fail conservative therapy. Plantar Fasciotomy: as a tool for tissue recession in patients with plantar…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0727-2017·2016-12-14

    AMD-Ritmed Transparent Dressing Recalled for Sterility Failure

    AMD-Ritmed is recalling Lot 68408 of transparent dressings because FDA testing found the sterile products were contaminated.

    Product
    AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0701-2017·2016-12-14

    3M Recalls Universal Electrosurgical Pads Due to Unintended Material Defect

    3M is recalling Universal Electrosurgical Pads because an unintended process liner may impede the safe return of electrosurgical current, increasing the risk of patient burns.

    Product
    3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Universal Electrosurgical Pad with Cord, REF 9135-LP (40 pads / case) Product Usage: 3M Universal Electrosurgical Pads are designed to work with most electrosurgical unite (ESU) for virtually every…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0723-2017·2016-12-14

    Siemens ADVIA 560 Hematology Systems Recalled for Incorrect Results

    Siemens is recalling ADVIA 560 Hematology Systems because a database issue may cause multiple discordant records to be generated for the same sample, leading to incorrect results.

    Product
    ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0707-2017·2016-12-14

    Merge Healthcare Recalls eFilm Workstation Software Due to Measurement Errors

    Merge Healthcare is recalling eFilm Workstation software versions 2.1 through 4.1 because RF projection images may display incorrect measurements without a calibration indicator.

    Product
    Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0721-2017·2016-12-14

    RayStation Radiation Therapy Software Recalled for Dose Calculation Errors

    RaySearch Laboratories is recalling RayStation software versions 4.0, 4.5, 4.7, and 5.0 due to potential inaccuracies in proton dose calculations for specific treatment plans.

    Product
    RayStation 4.0, 4.5, 4.7 and 5.0; 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0680-2017·2016-12-14

    Olympus Vanta Analytical X-Ray System Recalled for Unintentional Emission Risk

    Olympus is recalling 41 Vanta Analytical X-Ray Systems due to a risk of unintentional x-ray emission if users attempt to terminate the sequence early.

    Product
    Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0693-2017·2016-12-14

    Philips Brilliance 64 CT Systems Recalled for Software Error

    Philips Medical Systems is recalling 184 Brilliance 64 CT systems worldwide due to a software error involving the filament on timer.

    Product
    Brilliance 64 728231 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
  • HighFDA (Devices)·Z-0697-2017·2016-12-14

    Philips Ingenuity CT Systems Recalled for Software Timer Error

    Philips Medical Systems is recalling 371 Ingenuity CT systems worldwide due to a software error involving the filament on timer.

    Product
    Ingenuity CT 728326 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
  • HighFDA (Devices)·Z-0703-2017·2016-12-14

    DePuy Recalls LCS Knee Revision Insert Due to Manufacturing Defect

    DePuy Orthopaedics is recalling one lot of LCS Complete Knee Revision System VVC Inserts because they were manufactured outside of specifications, preventing proper seating in the tibial tray.

    Product
    LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
    Category
    Medical Device
    Distribution
    1 state
  • 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