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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38901–38925 of 40449

  • HighFDA (Devices)·Z-0860-2013·2013-02-27

    Codman & Shurtleff Recalls Neuropath Guiding Catheters Due to Sterility Concerns

    Codman & Shurtleff is recalling 268 units of Neuropath 6Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0836-2013·2013-02-27

    Animas Insulin Pumps Cease Operation Due to Calendar Date Limit

    Animas Corporation is recalling insulin infusion pumps that will stop operating on January 1, 2016, due to an internal calendar date limit.

    Product
    Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2013·2013-02-27

    Medrad Hand Controller Sheath Recalled for Potential Sterility Breach

    Medrad Inc is recalling Hand Controller Sheaths because a missing seal may compromise sterility. The product is used in cardiac catheterization procedures.

    Product
    MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0839-2013·2013-02-27

    Maquet ELS Cannula Recalled for Potential Arterial Lumen Occlusion

    Maquet is recalling ELS 15 FR Cannulas used for infant ECMO because they may contain an occluded arterial lumen.

    Product
    Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO) for the treatment of respiratory insufficiency in infants.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0841-2013·2013-02-27

    Elekta Monaco RTP System Recalled for Beam Angle Calculation Error

    Elekta is recalling 13 Monaco RTP Systems because the beam is displayed at the gantry angle, but the dose is calculated at the rotation_start angle.

    Product
    Monaco RTP System. Radiation treatment planning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0835-2013·2013-02-27

    Greiner Bio-One Recalls VACUETTE Safety Blood Collection Sets

    Greiner Bio-One is recalling VACUETTE Safety Blood Collection Sets because a crack in the luer connector may cause small droplets of blood to leak during use.

    Product
    VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12" Safety Blood Collect LA Product, Item number 450096. Usage: The Safety Blood Collection Set is used in routine venipuncture procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0837-2013·2013-02-27

    International Technidyne Recalls Pro Time 3 Cuvettes for Inaccurate PT/INR Results

    International Technidyne Corp. is recalling specific lots of Pro Time 3 Cuvettes because they may produce lower than expected Prothrombin Time/INR results.

    Product
    Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50. International Technidyne Corporation. The Pro Time Microcoagulation System is a portable battery operated instrument with a disposable cuvette for quantitative determination of prothrombin…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0832-2013·2013-02-27

    CareFusion Recalls SmartSite Gravity Blood Sets Due to Connection Separation

    CareFusion is recalling 5,050 units of SmartSite Gravity Blood Sets because the drip chamber and tubing may separate, potentially delaying treatment.

    Product
    CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blood and blood products through a needle or catheter inserted into the patient's artery or vein.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0842-2013·2013-02-27

    Codman NeuroPath Guiding Catheter Recalled for Packaging Integrity Issues

    Codman & Shurtleff is recalling 867 NeuroPath guiding catheters because packaging defects may compromise sterility. The devices were distributed worldwide.

    Product
    NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0861-2013·2013-02-27

    Codman NeuroPath Guiding Catheter Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling 141 units of NeuroPath 5Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0826-2013·2013-02-27

    ConMed Recalls Electrolase Hyfrecator Electrodes Due to Compromised Sterile Pouch Seals

    ConMed is recalling Electrolase Hyfrecator electrodes because some sterile pouch seals were compromised, potentially affecting sterility.

    Product
    ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0863-2013·2013-02-27

    Codman Neuropath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling Neuropath 6Fx90 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 6Fx90 GUIDING CATH S2 Product Code: GSM60900000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0858-2013·2013-02-27

    Codman NeuroPath Guiding Catheters Recalled for Potential Sterility Compromise

    Codman & Shurtleff is recalling NeuroPath 5Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2013·2013-02-27

    Integra MAYFIELD Composite Base Units Recalled for Potential Breakage

    Integra LifeSciences is recalling 96 MAYFIELD Composite Series Base Units because they may break during use, posing a risk to patients during surgical procedures.

    Product
    MAYFIELD¿ Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, Cincinnati, OH 45227 The MAYFIELD¿ Base Units are intended to be used to support a patient during diagnostic examination and/or surgical…
    Category
    Medical Device
    Distribution
    32 states
  • HighFDA (Devices)·Z-0871-2013·2013-02-27

    Philips HeartStart XL+ Defibrillators Recalled for Potential Lockout

    Philips is recalling 3,785 HeartStart XL+ defibrillators because they may become locked out of clinical use.

    Product
    Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0856-2013·2013-02-27

    Codman & Shurtleff Recalls NeuroPath Guiding Catheters Due to Sterility Concerns

    Codman & Shurtleff is recalling 1,548 NeuroPath 6Fx100 Guiding Catheters because package integrity issues may compromise device sterility.

    Product
    NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for use in the coronary, peripheral, and neurovasculature for intravascular introduction of interventional/diagnostic devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0866-2013·2013-02-27

    Merit Medical Systems Recalls Biliary Locking Drainage Catheters Due to Breakage

    Merit Medical Systems is recalling 387 Resolve Biliary Locking Drainage Catheters because a consumer reported the device broke into several pieces during use.

    Product
    Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage of bile within the biliary system.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0838-2013·2013-02-27

    Ansell Recalls LifeStyles ZERO 10 Latex Condoms Due to Breakage Complaints

    Ansell Healthcare Products LLC is voluntarily recalling LifeStyles ZERO 10 latex condoms due to complaints about difficulty unrolling and breakage.

    Product
    LifeStyles ZERO 10 uber-thin lubricated latex condoms. Mfd. for Ansell Healthcare Products LLC, Dothan, AL 96303. A sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0840-2013·2013-02-27

    Stryker Recalls AC Power Adaptors for Restep DVT System

    Stryker is recalling AC Power Adaptors for the Restep DVT System because wires may come loose, preventing the unit from operating.

    Product
    STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT (Pump Kit), and RSP159-01 (AC Power Adaptor).
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0827-2013·2013-02-27

    ConMed Recalls Electrolase Hyfrecator Electrodes Due to Compromised Sterile Seals

    ConMed is recalling specific lots of Electrolase Hyfrecator electrodes because some sterile pouch seals were compromised, potentially affecting sterility.

    Product
    ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips, Sterile, Rx Only --- CONMED CORPORATION USA. Intended to be used as active RF electrodes for desiccation, fulguration and coagulation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0825-2013·2013-02-27

    HealthTronics RenalCryo Cryoprobe Recalled for Incorrect Expiration Label

    Healthtronics, Inc. is recalling 50 units of Endocare 3.8mm RenalCryo Cryoprobes because the outer box labels display incorrect expiration dates.

    Product
    HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoProbe is an accessory probe intended for use with the CryoCare Surgical System, for freezing and ablation of tissue.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0749-2013·2013-02-20

    GE Healthcare Recalls Infant Resuscitation Systems Due to Reversed Fittings

    GE Healthcare is recalling 276 Giraffe and Panda Bag and Mask Resuscitation Systems because oxygen and air inlet fittings were reversed during assembly.

    Product
    Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
    Category
    Medical Device
    Distribution
    31 states
  • SevereFDA (Devices)·Z-0763-2013·2013-02-20

    St. Jude Medical Recalls TorqVue FX Delivery Systems Due to Fracture Risk

    St. Jude Medical is recalling 635 TorqVue FX Delivery Systems because the core wire could fracture during use.

    Product
    St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery System. Model #'s: 9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITVFX10F45/80 9-ITVFX12F45/80, 9-ITVFX13F45/80. Cardiac surgical instrument…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0795-2013·2013-02-20

    Lumenis Recalls VersaCut Tissue Morcellator for Labeling Corrections

    Lumenis Limited is recalling VersaCut Tissue Morcellator devices to correct labeling following three reported air embolism events caused by incorrect tubing hook-up.

    Product
    The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0748-2013·2013-02-20

    GE Healthcare Recalls Infant Resuscitation Systems Due to Reversed Fittings

    GE Healthcare is recalling 276 Giraffe and Panda T-Piece Resuscitation Systems because oxygen and air inlet fittings were reversed during assembly.

    Product
    GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
    Category
    Medical Device
    Distribution
    31 states