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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25201–25225 of 27686

  • HighFDA (Devices)·Z-1312-2014·2014-04-09

    Philips Pinnacle3 Radiation Therapy Planning System Software Recall

    Philips is recalling Pinnacle3 Radiation Therapy Planning System software version 9.0 due to a defect that can cause incorrect beam geometry.

    Product
    Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0.
    Category
    Medical Device
    Distribution
    49 states
  • CriticalFDA (Devices)·Z-1227-2014·2014-04-02

    Thoratec HeartMate II Implant Kit Recalled Due to Controller Switching Injuries

    Thoratec is recalling HeartMate II Implant Kits because serious injuries and deaths occurred when patients switched from primary to backup System controllers.

    Product
    HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1230-2014·2014-04-02

    Thoratec HeartMate II Pocket Controllers Recalled Due to Reported Deaths

    Thoratec is recalling HeartMate II Pocket Controllers because serious injuries and deaths were reported when patients switched from primary to backup controllers.

    Product
    Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1228-2014·2014-04-02

    Thoratec HeartMate II System Controller Recalled Due to Injury and Death Reports

    Thoratec is recalling HeartMate II System Controllers because serious injuries and deaths occurred when patients switched from primary to backup controllers.

    Product
    HeartMate II System Controller Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-229-2014·2014-04-02

    Thoratec HeartMate II LVAD Pump Recall Due to Controller Switching Injuries

    Thoratec is recalling 36 HeartMate II LVAD Pump and Pocket Controller Kits because switching from the primary to the backup controller caused serious injuries and deaths.

    Product
    HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1301-2014·2014-04-02

    BioCardia Morph AccessPro Steerable Introducer Recalled for Particulate Risk

    BioCardia is recalling Morph AccessPro Steerable Introducers due to potential particulates in the inner lumen that could cause an embolic event.

    Product
    Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1272-2014·2014-04-02

    Siemens AXIOM Artis Systems Recalled for Potential Gantry Drop Risk

    Siemens is recalling 37 AXIOM Artis angiography systems because a cooling unit defect may cause a system failure and gantry drop.

    Product
    AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1275-2014·2014-04-02

    Velocity Medical Solutions Recalls DICOM Export Format Software

    Velocity Medical Solutions is recalling DICOM Export Format for Sum Dose v3.0.0 software because it may replace calculated doses in Eclipse treatment plans.

    Product
    DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison of medical imaging data from multiple DICOM conformant imaging modality…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1303-2014·2014-04-02

    Medtronic Recalls FiberNet Embolic Protection System Due to Manufacturing Defect

    Medtronic is recalling specific lots of the FiberNet Embolic Protection System because a yellow polyimide tube was not removed during manufacturing.

    Product
    FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm, Maximum Guidewire Diameter: 0.014 in ( 0.36 mm) Rx only, Sterile; Manufactured in: Invatec S.P.A., Italy; Manufacturer: Medtronic Inc. Minneapolis, MN. The FiberNet Embolic Protection System…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1278-2014·2014-04-02

    Teleflex Recalls Weck Vista Optical Bladeless Laparoscopic Access Ports

    Teleflex Medical is recalling 55,521 Weck Vista Optical Bladeless Laparoscopic Access Ports due to reported gas leakage that may delay surgical procedures.

    Product
    5/10 mm Weck¿, Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1293-2014·2014-04-02

    Teleflex Medical Recalls Polypropylene Sutures for Needle Attachment Defect

    Teleflex Medical is recalling non-absorbable polypropylene sutures because they failed to meet minimum needle attachment strength requirements.

    Product
    Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is a monofilament, Non-absorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1284-2014·2014-04-02

    Teleflex Medical Recalls Weck Vista Universal Cannula Due to Gas Leakage

    Teleflex Medical is recalling 55,521 units of Weck Vista Universal Cannulas because they may leak insufflation gas, potentially delaying laparoscopic surgeries.

    Product
    5/10/12 mm Weck¿ Vista" Universal Cannula, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1291-2014·2014-04-02

    Teleflex Medical Recalls Non-absorbable Polyamide Surgical Sutures

    Teleflex Medical is recalling 32,271 units of non-absorbable polyamide surgical sutures because they failed to meet minimum needle attachment strength requirements.

    Product
    Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage: Non-absorbable polyamide surgical suture is a non-absorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1283-2014·2014-04-02

    Teleflex Vista Optical Bladeless Laparoscopic Access Port Recalled for Gas Leakage

    Teleflex Medical is recalling Vista Optical Bladeless Laparoscopic Access Ports because gas leakage can delay or prevent the completion of laparoscopic surgeries.

    Product
    5/10/12 mm Weck¿ Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1285-2014·2014-04-02

    Teleflex Medical Recalls Weck Vista Universal Cone Open Access Devices

    Teleflex Medical is recalling 55,521 Weck Vista Universal Cone Open Access devices due to reported gas leakage that may delay laparoscopic surgeries.

    Product
    5/10/12MM X 100MM Weck¿ Vista" UNIVERSAL CONE OPEN ACCESS, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1276-2014·2014-04-02

    Teleflex Medical Recalls Weck Vista Universal Laparoscopic Ports Due to Gas Leakage

    Teleflex Medical is recalling 55,521 Weck Vista Universal Laparoscopic Ports because they may leak insufflation gas, potentially delaying or complicating laparoscopic surgeries.

    Product
    Weck¿ Vista", Universal Laparoscopic Port, Size 5/10mmx100mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1280-2014·2014-04-02

    Teleflex Medical Recalls Weck Vista Universal Laparoscopic Ports Due to Gas Leakage

    Teleflex Medical is recalling 55,521 Weck Vista Universal Laparoscopic Ports because complaints were received regarding leakage of insufflation gas, which can delay surgical procedures.

    Product
    Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx100mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1287-2014·2014-04-02

    Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Port

    Teleflex Medical is recalling 55,521 units of the Weck Vista Universal Balloon Open Access Port due to reported gas leakage that may delay laparoscopic surgeries.

    Product
    5/10 Weck¿ Vista" Universal Balloon Open Access Port - Long Length (100mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1277-2014·2014-04-02

    Teleflex Medical Recalls 10mm Weck Vista Cannula Due to Gas Leakage

    Teleflex Medical is recalling 55,521 units of 10mm Weck Vista Cannula-only devices due to reported leakage of insufflation gas, which may delay laparoscopic surgeries.

    Product
    10mm Weck¿ Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1296-2014·2014-04-02

    Teleflex Medical Recalls Silk Sutures Due to Needle Attachment Defect

    Teleflex Medical is recalling 32,271 units of sterile silk sutures because they failed to meet minimum needle attachment strength requirements.

    Product
    Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1295-2014·2014-04-02

    Teleflex Medical Recalls Steel Sutures Due to Needle Attachment Strength Defect

    Teleflex Medical is recalling 32,271 units of non-absorbable steel sutures because they failed to meet minimum needle attachment strength requirements.

    Product
    Sutures, Non-absorbable, Steel, Monofilament and Multifilament, Sterile, Rx only, Product Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1281-2014·2014-04-02

    Teleflex Medical Recalls Weck Vista Universal Laparoscopic Ports

    Teleflex Medical is recalling 55,521 Weck Vista Universal Laparoscopic Ports due to reported gas leakage that may delay surgical procedures.

    Product
    Weck¿ Vista" Universal Laparoscopic Port, Size 5/10/12mmx125mm, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1292-2014·2014-04-02

    Teleflex Medical Recalls Non-absorbable Surgical Sutures for Needle Attachment Defect

    Teleflex Medical is recalling non-absorbable poly(ethylene terephthalate) surgical sutures because they did not meet minimum needle attachment strength requirements.

    Product
    Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage: Non-absorbable poly(ethylene terephthalate) surgical suture is a multifilament, non-absorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1288-2014·2014-04-02

    Teleflex Medical Recalls Weck Vista Universal Balloon Open Access Ports

    Teleflex Medical is recalling 55,521 units of Weck Vista Universal Balloon Open Access Ports due to reported gas leakage that may delay laparoscopic surgeries.

    Product
    5/10 Weck¿ Vista" Universal Balloon Open Access Port  Short Length (53mm), Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1279-2014·2014-04-02

    Teleflex Medical Recalls Weck Vista Universal Cannula Due to Gas Leakage

    Teleflex Medical is recalling 5/10 mm Weck Vista Universal Cannulas because they may leak insufflation gas, potentially delaying laparoscopic surgeries.

    Product
    5/10 mm Weck¿, Vista" Universal Cannula, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
    Category
    Medical Device
    Distribution
    Distributed nationwide