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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19301–19325 of 27647

  • CriticalFDA (Devices)·Z-2738-2017·2017-08-02

    Maquet CS 300 Intra-Aortic Balloon Pump Recalled Due to Device Failure

    Maquet Datascope is recalling 12,319 CS 300 Intra-Aortic Balloon Pumps because electrical test failures caused the device to fail to pump, which has been associated with a patient death.

    Product
    CS 300 Intra-Aortic Balloon Pump
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2778-2017·2017-08-02

    Invuity PhotonBlade Recalled for Potential Unintended Energy Discharge

    Invuity, Inc. is recalling 1,328 units of the INVUITY PhotonBlade device due to reports of unintended energy discharge that could cause tissue damage.

    Product
    INVUITY(R) PhotonBlade(TM), REF PB1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2764-2017·2017-08-02

    Medtronic Recalls DLP Extension Line Adapters Due to Packaging Pinholes

    Medtronic Perfusion Systems is recalling DLP Extension Line Adapters because small pinholes were found in a single packaging configuration of sterile pouches.

    Product
    DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2762-2017·2017-08-02

    Fisher Diagnostics Recalls FDP Assay Kits Due to False Negative Risk

    Fisher Diagnostics is recalling Pacific Hemostasis FDP Assay Kits and Latex Reagents because reduced sensitivity may cause false negative results at low FDP levels.

    Product
    Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2770-2017·2017-08-02

    Biomerieux Recalls VITEK 2 Gram Negative Test Kits Due to Errors

    Biomerieux Inc is recalling VITEK 2 Gram Negative test kits containing colistin because they produced high rates of major errors in susceptibility testing.

    Product
    VITEK 2 Gram Negative test kits containing colistin (cs01n)
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2763-2017·2017-08-02

    Fisher Diagnostics Recalls FDP Latex Reagent Due to Reduced Sensitivity

    Fisher Diagnostics is recalling specific lots of Pacific Hemostasis FDP Latex Reagent because reduced sensitivity may cause false negative test results.

    Product
    Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2767-2017·2017-08-02

    Medtronic Recalls DLP Pressure Monitoring Extension Line Adapters

    Medtronic Perfusion Systems is recalling DLP Pressure Monitoring Extension Line Adapters due to small pinholes in sterile packaging.

    Product
    DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2740-2017·2017-07-26

    Flowonix Recalls Prometra II Pump After Reported Fatal Overdose During MRI

    Flowonix Medical is recalling Prometra II implantable infusion pumps after a report of a fatal drug overdose during an MRI procedure.

    Product
    PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling of the device plus the following Prometra II pump labeling is also being…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2702-2017·2017-07-26

    Penumbra 3D Revascularization Device Recalled Due to Delivery Wire Breakage Risk

    Penumbra Inc. is recalling 155 units of the 3D Revascularization Device because a raw material issue could cause the delivery wire to break, potentially leading to serious injury or death.

    Product
    Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) within 8 hours of symptom…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2751-2017·2017-07-26

    BD 3ml Syringes Recalled for Insufficient Sterilization Irradiation

    Becton Dickinson is recalling 648,000 units of BD 3ml Syringes because several lots did not receive the specified dose of irradiation required to meet the Sterility Assurance Level.

    Product
    BD 3ml Syringe Luer-Lok" Tip Catalog 309657 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2752-2017·2017-07-26

    BD 10mL Syringes Recalled for Insufficient Sterilization Irradiation

    Becton Dickinson is recalling 547,600 units of BD 10mL Syringes because several lots did not receive the specified dose of irradiation required to meet Sterility Assurance Level standards.

    Product
    BD 10mL Syringe Luer-Lok Tip Catalog number 301997 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2744-2017·2017-07-26

    Pentax Medical Recalls Laryngeal Strobe Systems Due to Missing Transformers

    Pentax Medical is recalling 241 laryngeal strobe systems because isolation transformers were not always provided, posing a potential electrical safety risk.

    Product
    9400 Laryngeal Strobe Product Usage: The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medical and pedagogical applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2742-2017·2017-07-26

    Pentax Medical Recalls Video Systems Due to Missing Isolation Transformers

    Pentax Medical is recalling 241 units of 7245C, 7245C/E, and 7245D Computer Digital Video Systems because they may have been shipped without required 9175 isolation transformers.

    Product
    7245C, 7245C/E, 7245D Computer Digital Video System Product Usage: The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior related to swallowing in the pharyngeal area for medical and pedagogical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2750-2017·2017-07-26

    BD 3ml Syringes Recalled for Insufficient Sterilization Irradiation

    Becton Dickinson is recalling 340,000 units of BD 3ml Syringes because several lots did not receive the specified dose of irradiation required to meet Sterility Assurance Level standards.

    Product
    BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #309580 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2748-2017·2017-07-26

    BD SafetyGlide Injection Needle Recall Due to Sterility Assurance Issues

    Becton Dickinson is recalling 29,500 units of BD SafetyGlide Injection Needles because several lots did not receive the specified dose of irradiation required to meet Sterility Assurance Level (SAL) standards.

    Product
    BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2753-2017·2017-07-26

    BD 3ml Syringes Recalled for Insufficient Sterilization Irradiation

    Becton Dickinson is recalling 1,528,000 units of 3ml syringes because several lots did not receive the specified dose of irradiation required to meet sterility standards.

    Product
    BD 3ml Syringer Luer-Lok Tip Catalog #309604 The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2735-2017·2017-07-26

    Agfa Healthcare Recalls NX 3.0.8950 Imaging Processing Software

    Agfa Healthcare is recalling NX 3.0.8950 software because it may temporarily display and transmit incorrect patient images to PACS systems.

    Product
    Agfa Healthcare NX 3.0.8950 Imaging Processing Software
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2746-2017·2017-07-26

    Medtronic Navigation Recalls Spine Tool Install CD Version 25

    Medtronic Navigation is recalling 108 Spine Tool Install CD units (Model 9731958) due to a software issue that may prevent navigation of surgical instruments during spine procedures.

    Product
    Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
    Category
    Medical Device
    Distribution
    Distributed nationwide