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 40449

  • HighFDA (Devices)·Z-0427-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Potts Scissors Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 8mm Potts Scissors because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0447-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Curved Bipolar Dissectors Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Curved Bipolar Dissectors because deviations in reprocessing steps can cause surface degradation and mechanical wear.

    Product
    8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0429-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Black Diamond Micro Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Black Diamond Micro Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0485-2015·2014-12-03

    Respironics Esprit V1000 Ventilator Recall for Power Supply Defect

    Respironics is recalling Esprit V1000 and V200 Conversion Ventilators because incorrect screw installation may cause a short circuit, preventing the switch to battery power during AC outages.

    Product
    Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Intended for use by medical personnel to provide continuous or intermittent…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0471-2015·2014-12-03

    Toshiba Cardiac Function Analysis Software Recalled for Incorrect Results

    Toshiba American Medical Systems is recalling one unit of cardiac function analysis software in the US because it may display incorrect analysis results.

    Product
    Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301C X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and permits…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0464-2015·2014-12-03

    Vision RT AlignRT System Recalled for Potential Interlock Failure

    Vision RT is recalling AlignRT systems due to a potential failure to assert interlock, which could affect radiation safety during treatment.

    Product
    AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0422-2015·2014-12-03

    Hospira Recalls GemStar Infusion Pumps Due to Unauthorized Dosage Reset Access

    Hospira is recalling GemStar infusion pumps because patients are accessing dosage reset codes to change infusion rates set by doctors.

    Product
    GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (pain management) list number 13088. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0441-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Large Hem-O-Lok Clip Applier Devices

    Intuitive Surgical is voluntarily recalling 509 units of 8mm Large Hem-O-Lok Clip Appliers due to a Class II device defect. The affected instruments were distributed to facilities in eight US states.

    Product
    8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0419-2015·2014-12-03

    Gyrus ACMI Falope-Ring Band Applicator Kits Recalled for Sterile Packaging Compromise

    Gyrus Acmi is recalling Falope-Ring Band Applicator Kits due to sterile packaging compromises that could lead to bacterial contamination and patient infection.

    Product
    Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0432-2015·2014-12-03

    Intuitive Surgical Recalls 8mm ProGrasp Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 8mm ProGrasp Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0439-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Tenaculum Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Tenaculum Forceps because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0442-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Atrial Retractor Instruments Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Atrial Retractor Short Right instruments because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0443-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Dual Blade Retractors for Reprocessing Issues

    Intuitive Surgical is recalling 509 units of 8mm Dual Blade Retractors because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0446-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Clip Appliers Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm clip appliers because deviations in reprocessing steps can cause surface degradation and mechanical wear.

    Product
    8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0473-2015·2014-12-03

    Philips IntelliSpace Portal Software Defect May Display Incorrect Cardiac Measurements

    Philips is recalling 32 IntelliSpace Portal systems due to a software defect that may display incorrect cardiac and aortic anatomy measurements used for sizing Transcatheter heart valves.

    Product
    IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model number; 881030 System, x-ray, tomography, computed
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0421-2015·2014-12-03

    Hospira Recalls GemStar Infusion Pumps Due to Unauthorized Dosage Reset Access

    Hospira Inc. is recalling GemStar infusion pumps because patients are using publicly available codes to change infusion rates set by doctors.

    Product
    GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of general I.V. fluids…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0434-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Monopolar Curved Scissors Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 units of 8mm Monopolar Curved Scissors because deviations in reprocessing steps can cause surface degradation and mechanical wear.

    Product
    8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0435-2015·2014-12-03

    Intuitive Surgical Recalls 8mm Resano Forceps Due to Reprocessing Deviations

    Intuitive Surgical is recalling 509 8mm Resano Forceps instruments because deviations in reprocessing steps can cause surface degradation and accelerated mechanical wear.

    Product
    8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-0467-2015·2014-12-03

    Biomerica Recalls Calcitonin ELISA Kits Due to Potential False High Values

    Biomerica is recalling Calcitonin ELISA Kits because they may produce false high values. The recall covers 1,062 units distributed worldwide.

    Product
    Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0425-2015·2014-12-03

    Discus Dental Recalls Relief ACP Oral Care Gel Due to Filling Error

    Discus Dental LLC is recalling Relief ACP Oral Care Gel because some units were filled with hydrogen peroxide instead of phosphate gel, potentially causing increased sensitivity.

    Product
    Relief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0476-2015·2014-12-03

    Dharma Cavity Varnish Recalled for Missing FDA Clearance

    Dharma Research, Inc. is recalling Dharma Cavity Varnish 15mL because the product was marketed without a cleared 510(k) submission.

    Product
    Dharma Cavity Varnish 15mL
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0477-2015·2014-12-03

    ZOLL Recalls NeuroFlo Catheter Due to Missing Regulatory Filing

    ZOLL Circulation is recalling one lot of NeuroFlo Catheters because a required regulatory supplement was not filed after the company acquired the product's assets.

    Product
    7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasospasm following aneurysmal subarachnoid hemorrhage. The NeuroFlo Catheter is…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0418-2015·2014-12-03

    Materialise Recalls Zimmer Patient Specific Instrument PERSONA CR Pin Guides

    Materialise USA LLC is recalling specific Zimmer Patient Specific Instrument PERSONA CR Pin Guides because the packaging contained incorrect components and one guide exceeded size specifications.

    Product
    Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0484-2015·2014-12-03

    CooperSurgical LEEP Loop Electrode Recalled for Outer Box Mislabeling

    CooperSurgical is recalling LEEP Radius Loop Electrodes because the outer box is mislabeled with the wrong part number.

    Product
    CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ). Box of 5 Model Number(s): R2010 Intended Use: Diagnosis and treatment of non-invasive HPV-related or unrelated lesions of the lower genital tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0465-2015·2014-12-03

    Remel Recalls Legionella Pneumo Groups 2-14 Latex Test Kits

    Remel Inc is recalling specific lots of the Oxoid Legionella Pneumo Groups 2-14 Latex Test because a reagent may produce false negative results.

    Product
    Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxoid L. pneumophila Group 2-14 Latex Reagent, Lot 1301912. The product is a latex agglutination test for the identification of…
    Category
    Medical Device
    Distribution
    Distributed nationwide