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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34426–34450 of 40325

  • SevereFDA (Devices)·Z-0202-2015·2014-11-19

    Medacta Recalls GMK Intramedullary Extension Rods Due to Breakage Reports

    Medacta is recalling GMK Intramedullary Extension Rods 100 mm after three reported cases of breakage during total knee replacement surgeries.

    Product
    GMK Intramedullary Extension Rod 100 mm is a rod to obtain correct leg alignment during total knee replacement. Rod to obtain correct leg alignment during total knee replacement.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0184-2015·2014-11-19

    GE Healthcare Infinia Nuclear Medicine Systems Recalled for Loose Fasteners

    GE Healthcare is recalling Infinia nuclear medicine systems because loose fasteners could cause a portion of the system to fall onto a patient during a scan.

    Product
    GE Healthcare Infinia (including Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye, Infinia II Hawkeye 4, Infinia II VC, Infinia II VC Hawkeye, and Infinia II VC Hawkeye 4) Models: H3000WC, H3000WD, H3000WE, H3000WM, H3000WN, H3000WP, H3000WR, H3000WT, H3000WW, H3000WY…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0182-2015·2014-11-19

    Philips Allura Xper FD20C Recalled for Faulty Motion Controller

    Philips Medical Systems is recalling two Allura Xper FD20C systems due to a faulty Automatic Motion Controller that may cause hazardous C-arc movement.

    Product
    Philips Medical Systems Allura Xper FD20C with software version R8.2.O System Code: 722035. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and…
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0170-2015·2014-11-19

    Siemens MicroScan Rapid Neg BP Combo Panel Type 3 Recalled for False Positives

    Siemens Healthcare Diagnostics is recalling 1,381 units of Rapid Neg BP Combo Panel Type 3 due to an increase in false positive susceptible results.

    Product
    Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0210-2015·2014-11-19

    Fisher and Paykel Infant Warmer Recall Due to Heater Head Breakage

    Fisher and Paykel Healthcare is recalling IW900-Series Infant Warmers and spare parts because a broken nut may allow the heater head to swing and injure infants.

    Product
    Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcare CosyCot and Kit Replacement Head Case Assembly It is designed to assist with the thermoregulation of infants weighing up to 10kg and is used by labor and delivery rooms and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0188-2015·2014-11-19

    GE Optima NM/CT 640 Recalled for Loose Camera Fasteners

    GE Healthcare is recalling 29 Optima NM/CT 640 systems because loose fasteners could cause the camera to fall onto a patient during a scan.

    Product
    Optima NM/CT 640, Models H3100YA, H3100YC. Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0181-2015·2014-11-19

    Philips Allura Xper FD20C Radiological Imaging Systems Recalled for Motion Controller Fault

    Philips is recalling 22 Allura Xper FD20C radiological imaging systems due to a faulty Automatic Motion Controller that may cause hazardous movement of the C-arc.

    Product
    Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including…
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0186-2015·2014-11-19

    GE Discovery NM/CT 670 Imaging System Recalled for Loose Fasteners

    GE Healthcare is recalling 255 Discovery NM/CT 670 systems because loose fasteners may cause a portion of the system to fall onto patients during scans.

    Product
    Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0196-2015·2014-11-19

    Steris 5085 Surgical Tables Recalled for Damaged Column Shrouds

    Steris is recalling 5085 and 5085SRT surgical tables because column shrouds may become damaged, potentially preventing the table from raising or lowering.

    Product
    The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-0209-2015·2014-11-19

    American Medical Systems Recalls AMS 700 Series Inflatable Penile Prosthesis Accessory Kits

    American Medical Systems is recalling AMS 700 Series Accessory Kits because supplier-supplied Keith needles may bend or break when used with the Furlow tool.

    Product
    AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (Furlow), the Keith Needles facilitate the passing of the pulling sutures…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0199-2015·2014-11-19

    DePuy ATTUNE Intuition Distal Femoral Jig Recall for Bushing Defect

    DePuy Orthopaedics is recalling ATTUNE Intuition Distal Femoral Jigs because a pin bushing defect could cause the plastic to fracture or displace during use.

    Product
    ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0200-2015·2014-11-19

    Remel Legionella Growth Supplement Recalled for Potential False Negative Results

    Remel Inc is recalling Legionella BCYE Growth Supplement because it may fail to recover Legionella pneumophila, leading to false negative identification.

    Product
    Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0183-2015·2014-11-19

    Siemens Artis zeego C-arm systems recalled for cable routing defect

    Siemens is recalling 164 Artis zeego systems because a cable may be routed incorrectly, potentially causing system failure during procedures.

    Product
    Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0213-2015·2014-11-19

    Masimo SET uSpO2 Pulse Oximetry Cables Recalled for Crossed Wires

    Masimo Corporation is recalling specific SET uSpO2 Pulse Oximetry Cables due to crossed internal wires that may cause the monitoring device to display inverted SpO2 values.

    Product
    Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. Shipping/Package…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0185-2015·2014-11-19

    GE Healthcare Recalls Varicam and VG Hawkeye Nuclear Medicine Devices

    GE Healthcare is recalling 478 nuclear medicine imaging devices because loose fasteners could cause a portion of the system to fall onto a patient during a scan.

    Product
    GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, H2508PD. Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0197-2015·2014-11-19

    Integra Titan Reverse Shoulder System Cutting Templates Recalled for Manufacturing Error

    Integra LifeSciences Corp. is recalling 12 units of Reverse Shoulder System cutting templates because the threaded handle was welded backwards, resulting in an incorrect cutting angle.

    Product
    Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The Reverse Shoulder System Cutting Template, 142.5 degrees is an accessory for use with the Integra Titan Reverse Shoulder System. It is used to project the osteotomy angle on the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0189-2015·2014-11-19

    GE Healthcare Recalls Brivo NM615 Nuclear Imaging Systems Due to Loose Fasteners

    GE Healthcare is recalling 22 Brivo NM615 nuclear imaging systems because loose fasteners could cause a portion of the system to fall onto a patient during a scan.

    Product
    Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3100WZ, H2401MP, H2401MN, H2401MT, H2401MR, H2401MW, H2401NJ. Product Usage: The Brivo NM 615 is an emission computed tomography system…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0187-2015·2014-11-19

    GE Healthcare Recalls Discovery NM 630 Nuclear Imaging Systems

    GE Healthcare is recalling 147 Discovery NM 630 nuclear imaging systems to update maintenance procedures and prevent loose fasteners from causing parts to fall on patients.

    Product
    Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3100RD, H2401LW. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0204-2015·2014-11-19

    Roscoe Medical Recalls Transport Rollators Due to Caster Separation Risk

    Roscoe Medical Inc is recalling 831 Transport Rollators because the caster may separate from the frame, posing an injury risk to users.

    Product
    Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and outdoor use), fold down footrests, ergonomic handles, curved padded backrest and handy wire basket for storage. Item# 30192 Burgundy each/Item# 30194 Blue each.. Transport Rollator is a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0191-2015·2014-11-19

    Bard PerFix Light Plug Recalled for Labeling Mismatch

    Davol, Inc. is recalling 78 units of Bard PerFix Light Plug because the patient record label did not match the actual product in the packaging.

    Product
    Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0211-2015·2014-11-19

    Maquet Cardiohelp-I System Recalled for Potential Software Display Error

    Maquet Cardiovascular is recalling 331 Cardiohelp-I Systems due to a software issue that may display an erroneous 'Battery Needs Service' message after startup.

    Product
    Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours).…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0193-2015·2014-11-19

    GE OEC MiniView 6800 C-Arm Recall for Component Revision

    GE Healthcare is recalling 26 OEC MiniView 6800 C-Arms because prior component revisions may have been incorrectly installed.

    Product
    OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0205-2015·2014-11-19

    Medtronic Launcher Coronary Guide Catheter Recalled for Incorrect Length

    Medtronic Vascular is recalling 11 Launcher Coronary Guide Catheters because they have a usable length of 90 cm instead of the labeled 55 cm.

    Product
    Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0201-2015·2014-11-19

    Integra Licox Pt02 Monitor Recalled for USB Data Extraction Issues

    Integra LifeSciences is recalling 60 Licox Pt02 monitors because the USB port may not allow users to extract trend data as described in the manual.

    Product
    Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0192-2015·2014-11-19

    GE OEC UroView 2800 Imaging Systems Field Correction for Component Revision

    GE Healthcare is correcting OEC UroView 2800 systems because prior component revisions may have been incorrectly installed.

    Product
    OEC¿ UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional procedures
    Category
    Medical Device
    Distribution
    0 states