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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26426–26450 of 27722

  • HighFDA (Devices)·Z-1565-2013·2013-07-03

    Baxter MiniCap with Povidone-Iodine Solution Recalled for Leaking Pouches

    Baxter Healthcare is recalling 629,280 units of MiniCap with Povidone-Iodine solution for dialysis due to leaking pouches. The recall is voluntary and nationwide.

    Product
    Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. Intended to isolate the Easy-Lock connector of the solution transfer set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1593-2013·2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1607-2013·2013-07-03

    Medtronic Recalls Specific CRT-P Pacemakers for Potential Malfunction

    Medtronic is recalling specific Consulta and Syncra CRT-P pacemakers manufactured in April and May 2013 due to a production issue that could cause malfunction. No device failures have been reported.

    Product
    Medtronic, Consulta¿ CRT-P, Model C4TR01, C3TR01 (not approved for US), and Syncra¿ CRT-P, Model C2TR01, Sterile EO. Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Devices)·Z-1602-2013·2013-07-03

    Baxter Recalls Regional Analgesia Infusor Systems Due to Rupture Complaints

    Baxter Healthcare is recalling Regional Analgesia Infusor Systems with Patient Control due to an increase in rupture complaints. The recall covers 3,255,096 units distributed nationwide and in Puerto Rico.

    Product
    Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1601-2013·2013-07-03

    Baxter Recalls Multirate Infusor Devices Due to Rupture Complaints

    Baxter Healthcare is recalling 3,255,096 Multirate Infusor Devices due to an increase in rupture complaints. The devices are indicated for the intravenous administration of medications.

    Product
    Brand Name: Multirate Infusor Devices. Indicated for the intravenous administration of medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1578-2013·2013-07-03

    Prism Medical C-Series Carry Bar Recalled for Improper Installation

    Prism Medical Services USA is recalling 1,131 C-Series Carry Bars due to improper installation. The firm is replacing them with a plastic insert and metal insert carry bar.

    Product
    Prism Medical C-Series Carry Bar, Class I, model number 360755. The intended use is a carry bar attached to a C-450 or C-625 ceiling lift used to lift, transfer or position clients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1605-2013·2013-07-03

    Baxter Recalls SV Elastomeric Infusion Devices Due to Rupture Complaints

    Baxter Healthcare is recalling SV Elastomeric Infusion Devices due to an increase in rupture complaints. The devices are used for intravenous medication administration.

    Product
    Brand Name: SV Elastomeric Infusion Device. Indicated for the intravenous administration of medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1600-2013·2013-07-03

    Baxter Recalls Infusor SV and LV Elastomeric Infusion Devices Due to Rupture Complaints

    Baxter Healthcare is recalling Infusor SV and LV Elastomeric Infusion Devices due to an increase in rupture complaints. The recall aims to ensure no affected product remains in the field.

    Product
    Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for the intravenous administration of medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1581-2013·2013-07-03

    Roche Recalls CoaguChek XS Meters Due to Potential INR Test Errors

    Roche is recalling CoaguChek XS meters because they may display an error message instead of a value, potentially leading to undetected elevated INR results.

    Product
    CoaguChek XS System (PST) The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System measures blood-clotting time for people who are taking anticoagulation medications such as Coumadin¿ or warfarin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2013·2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling 400 units of INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1590-2013·2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1584-2013·2013-07-03

    Roche Recalls CoaguChek XS Meters Due to Potential Test Errors

    Roche is recalling CoaguChek XS System meters because they may display an error message instead of a value, potentially leading to undetected elevated INR results.

    Product
    CoaguChek XS System (HCP) The CoaguChek XS System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1589-2013·2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1558-2013·2013-06-26

    Verathon Recalls GlideScope Reusable Laryngoscope Blades Due to Breakage Risk

    Verathon is recalling GlideScope reusable laryngoscope blades because the tips may break prematurely without visible signs, posing a risk to patients during intubation.

    Product
    GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4 and 5 reusable blades Product Usage: The GlideScope Video Laryngoscopes are intended for use by qualified medical professionals to obtain a clear, unobstructed view of the vocal cords for medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1537-2013·2013-06-26

    Respironics V60 Ventilator Recalled for Power Management Board Software Issue

    Respironics is recalling V60 ventilators due to a software issue on the Power Management Board Assembly that could cause loss of ventilator support without an audible alarm.

    Product
    Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 12 Digit P/N): 85008 (85008) 1053613 (989805628251) 1053614 (989805612101) 1053615 (989805613391) 1053616 (989805613661) 1053617 (989805611761) 1053618 (n/a) R1053618 (n/a) 1076709 (n/a)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1548-2013·2013-06-26

    Biomet Recalls Superior Approach Resection Guide Assembly Due to Slot Offset

    Biomet is recalling 17 units of the Superior Approach Resection Guide Assembly because a manufacturing defect may prevent the guide from securing properly to bone during surgery.

    Product
    Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1547-2013·2013-06-26

    Biomet Recalls Phoenix Retrograde Femoral Connecting Bolts Due to Fit Issues

    Biomet is recalling 75 Phoenix Retrograde Femoral Connecting Bolts because an undersized diameter may cause the hex driver to get stuck, delaying surgery.

    Product
    Biomet Trauma Phoenix Retrograde Femoral Connecting Bolt Trauma Fixation Systems. Product Usage: The Phoenix Retrograde Femoral Nail is indicated for alignment, stabilization, and fixation of fractures caused by trauma or disease and the fixation of femurs that have been…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1551-2013·2013-06-26

    GE Healthcare Recalls PET VCAR Software Due to Calculation Error

    GE Healthcare is recalling PET VCAR software due to a potential safety issue with automated PERCIST response criteria calculations.

    Product
    GE Healthcare, PET VCAR. PET VCAR application software is affected if installed on any of the following versions of the Advantage Workstation and AW Server: Advantage Workstation 4.6, Volume Share 5 enhanced  vxtl.11.3, vxtl.11.3 ext1, or vxtl.11.3 ext2 AW Server 2.0, Volume…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1561-2013·2013-06-26

    Linde Gas Recalls MEDICYL-e Portable Oxygen Systems Due to Valve Defect

    Linde Gas North America is recalling MEDICYL-e Portable Oxygen Systems because some units may have misapplied valve flow knobs.

    Product
    MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MRI safe, MRI-compatible, and intended for use during MR Imaging for MRI systems up to 3.0 T. For emergency use only when…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2013·2013-06-26

    Philips BuckyDiagnost Radiographic Systems Recalled for Table Height Defects

    Philips Healthcare is recalling 116 BuckyDiagnost radiographic systems because table height measurements were found out of specification, potentially causing system mis-alignment.

    Product
    Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1546-2013·2013-06-26

    Zimmer Patient Helper Bed Frame Adapter Assembly Recalled for Weak Welds

    Zimmer, Inc. is recalling 344 Patient Helper Bed Frame Adapter Assemblies because they may have a weak weld where the mounting bars attach to the tube.

    Product
    Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is intended to be used by qualified medical professionals to adapt a patient helper to a hospital bed. The patient helper is used to aid and assist the patient's mobility within a hospital bed and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1560-2013·2013-06-26

    Tecan Freedom EVO Software Recall for Door Lock Safety Defect

    Tecan US, Inc. is recalling 12 Freedom EVO instruments with Touch Tools Suite 3.0 because door lock errors are ignored, potentially causing unexpected movement and operator injury.

    Product
    Tecan Freedom EVO with Touch Tools Suite Version 3.0 The intended use of the Touch Tools Suite is to run previously defined scripts and processes on a Freedom EVO platform (Touch Tools Suite is an optional software add-on for Freedom EVOware (the base operational software…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1436-2013·2013-06-19

    Endologix AFX Introducer System Recalled for Dilator Breakage

    Endologix Inc. is voluntarily recalling 53 units of the AFX Introducer System due to reports of dilator breakage during clinical procedures.

    Product
    Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1536-2013·2013-06-19

    OrthoPediatrics Recalls 90 Degree Cannulated Infant Blade Plates

    OrthoPediatrics Corp is recalling 130 90 Degree Cannulated Infant Blade Plates due to reports of the plates bending during surgery.

    Product
    90 Degree Cannulated Infant Blade Plate 35mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1535-2013·2013-06-19

    OrthoPediatrics Recalls 90 Degree Cannulated Infant Blade Plates

    OrthoPediatrics Corp is recalling 90 Degree Cannulated Infant Blade Plates due to reports of the plates bending during surgery.

    Product
    90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults.…
    Category
    Medical Device
    Distribution
    Distributed nationwide