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

23751–23775 of 27663

  • HighFDA (Devices)·Z-1152-2015·2015-03-04

    Navilyst NAMIC Convenience Kits Recalled for Potential Sterility Breach

    Navilyst Medical is recalling NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600309351, REF/Catalog No. 60030935, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1148-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 15 units of NAMIC Convenience Kits because expiration dating is not fully supported by testing, posing a potential sterility breach and infection risk.

    Product
    NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496001001111, REF/Catalog No. 600100111, STERILE, Rx ONLY For single use only. ---Device Listing Number D136588. Product Usage: NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1189-2015·2015-03-04

    Navilyst Medical Recalls NAMIC Convenience Kits Due to Sterility Concerns

    Navilyst Medical is recalling 2,502 NAMIC Convenience Kits because expiration dating is not fully supported by testing, which may result in a sterility breach and increased infection risk.

    Product
    NAMIC Convenience Kit, UPN H749602301481, REF/Catalog No. 60230148, STERILE, Rx ONLY --- For single use only. --- Device Listing Number D136588. NAMIC Convenience Kits are intended to be used in Fluid Management and/or Invasive Pressure Monitoring Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1035-2015·2015-02-25

    GE Healthcare MRI Systems Recalled for Potential Ferrous Object Removal Delay

    GE Healthcare is recalling MRI systems because a disconnected MRU could delay the removal of ferrous objects, posing a life-threatening injury risk.

    Product
    This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1061-2015·2015-02-25

    Alltech Medical Systems Recalls Two MRI Systems Due to Safety Feature Failure

    Alltech Medical Systems America Inc is recalling two Echostar Spica 1.5T MRI systems because the emergency magnetic field lowering feature may not work correctly.

    Product
    Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1128-2015·2015-02-25

    Mako Surgical Recalls Restoris Partial Knee Application RIO Due to Burr Malfunction

    Mako Surgical Corporation is recalling 228 units of the Restoris Partial Knee Application RIO because the surgical burr may continue spinning outside the intended boundary after controls are released.

    Product
    Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1126-2015·2015-02-25

    CME America Recalls BodyGuard 323 Infusion Pumps for Over-Delivery Risk

    CME America is recalling BodyGuard and BodyGuard 323 infusion pumps due to a potential for over-delivery of medication.

    Product
    BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1127-2015·2015-02-25

    Nidek MC-500 Laser Photocoagulator Recalled for Spot Size Control Defect

    Nidek Inc is recalling 16 MC-500 Multicolor Laser Photocoagulators because the spot size control may turn by itself, posing a risk of unintended laser delivery.

    Product
    MC-500 Multicolor Laser Photocoagulator; Indicated for use in retinal photocoagulation for treatment of ocular fundus diseases like diabetic retinopathy, age-related macular degeneration, retinopathy of prematurity and retinal detachment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1116-2015·2015-02-25

    Terumo HX2 Temperature Management System Recalled for Valve Malfunction

    Terumo is recalling 103 HX2 Temperature Management Systems because a malfunctioning mixing valve can cause loss of cooling or heating capability during surgery.

    Product
    Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1051-2015·2015-02-18

    Teleflex Recalls MAQUET SERVO Humidifiers Due to Cracked Flex Tubes

    Teleflex Medical is recalling MAQUET SERVO Humidifier 163 units because cracks may occur in the corrugated flex tube, posing a risk to patients.

    Product
    MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal…
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1089-2015·2015-02-18

    Biomet Telluride Percutaneous Rod Inserter Long Recalled for Design Defect

    Biomet Spine is recalling 10 units of the Telluride Percutaneous Rod Inserter Long because the device lacks a locking feature, posing a risk of rod disengagement during surgery.

    Product
    Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. The case consists of three trays of instruments, and the middle tray contains a…
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1090-2015·2015-02-18

    Stryker Recalls MEDPOR Surgical Implants Due to Potential Intraoperative Damage

    Stryker is recalling MEDPOR Surgical Implants because they may crack or break during surgery. The recall affects 1,051 units distributed worldwide.

    Product
    MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1091-2015·2015-02-18

    Stryker Recalls MEDPOR BARRIER Sheets for Potential Deformation and Cracking

    Stryker is recalling MEDPOR BARRIER Sheets due to risks of deformation, cracking, and loss of adhesion during surgery.

    Product
    MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1008-2015·2015-02-18

    Teleflex Recalls MAQUET Servo Humidifier 163 Due to Connector Cracks

    Teleflex is recalling 18 MAQUET Servo Humidifier 163 units because connector mount cracks may cause leaks, potentially depriving patients of adequate anesthetic gases.

    Product
    MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the…
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-1092-2015·2015-02-18

    Stryker Recalls MEDPOR BARRIER Sheets Due to Deformation and Cracking Risks

    Stryker is recalling MEDPOR BARRIER Sheets due to potential implant deformation, mechanical instability, and cracking during surgery.

    Product
    MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1064-2015·2015-02-18

    Virtual Imaging Recalls Digital Mobile X-ray Systems Due to Motion Defect

    Virtual Imaging, Inc. is recalling 316 digital mobile X-ray systems in the US and 6 in Canada due to a potential for unintended and erratic motion.

    Product
    Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2015·2015-02-18

    Teleflex Medical Recalls Aquapak 340 SW Humidifier Adaptors for Foreign Material

    Teleflex Medical is recalling Aquapak 340 SW humidifier adaptors because the packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1087-2015·2015-02-18

    Siemens Symbia T Series Medical Imaging Systems Recalled for Bearing Failure

    Siemens Medical Solutions is recalling Symbia T series imaging systems because a linear bearing car may fail, allowing ball bearings to fall out.

    Product
    The Siemens Symbia T series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1101-2015·2015-02-18

    Teleflex Medical Recalls Aquapak 340 Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling Aquapak 340 Humidifier Adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1102-2015·2015-02-18

    Teleflex Medical Recalls Aqua 540 Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling Aqua 540 Humidifier Adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1084-2015·2015-02-18

    Integra Recalls Mayfield Ultra 360 Base Units Due to Locking Handle Failure

    Integra LifeSciences is recalling 1,053 Mayfield Ultra 360 Base Units because the locking handle mechanism may fail during use, posing a risk to patients.

    Product
    The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1086-2015·2015-02-18

    Siemens Symbia S Series Medical Imaging Systems Recalled for Bearing Failure

    Siemens Medical Solutions is recalling 719 Symbia S series systems because a linear bearing car may fail, allowing ball bearings to fall out.

    Product
    The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1107-2015·2015-02-18

    Teleflex Medical Recalls 040 Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling 040 Humidifier Adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    ADAPTOR, 040 HUM, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1104-2015·2015-02-18

    Teleflex Medical Recalls Aquapak Sterile Water Adaptors for Foreign Material

    Teleflex Medical is recalling Aquapak sterile water humidifier adaptors because packages may contain black particles.

    Product
    AQUAPAK SW/EAU STERILE, 650 ML W/ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1063-2015·2015-02-18

    Siemens ACUSON S2000 Breast Scanner Recall for Detachment Risk

    Siemens is recalling 24 ACUSON S2000 breast scanners because the scanner arm may detach from the column.

    Product
    ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image.
    Category
    Medical Device
    Distribution
    2 states