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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19351–19375 of 27682

  • 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
  • HighFDA (Devices)·Z-2749-2017·2017-07-26

    BD 3ml Syringes Recalled for Insufficient Sterilization Irradiation

    Becton Dickinson is recalling 57,600 units of BD 3ml Syringes with PrecisionGlide Needles because some lots did not receive the required dose of irradiation to ensure sterility.

    Product
    BD 3ml Syringe Luer-Lok" Tip with BD PrecisionGlide" Needle 23G x 1 (0.6mm x 25mm) Catalog #309571 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-2741-2017·2017-07-26

    Mako Surgical Recalls MAKO RIO Standard System Card Cages

    Mako Surgical Corporation is recalling 20 MAKO RIO Standard System internal cPCI Card Cages due to an intermittent electrical problem that could cause a loss of system power.

    Product
    MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-2734-2017·2017-07-26

    Draeger Infinity Acute Care System Recall for Alarm Failure

    Draeger Medical Systems is recalling Infinity Acute Care Systems (M540) because specific units may fail to display audio or visual alarms.

    Product
    Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: MK31501/MK31701/MK31722
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2686-2017·2017-07-26

    Siemens Artis zee X-ray System Recalled for Component Defect

    Siemens is recalling specific Artis zee angiographic x-ray systems due to a component defect that can cause failures.

    Product
    Artis zee,x-ray system, angiographic 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. Procedures that can be performed with the…
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-2747-2017·2017-07-26

    BD 5ml Syringes Recalled for Insufficient Sterilization Irradiation

    Becton Dickinson is recalling 22,400 units of 5ml syringes because several lots did not receive the specified dose of irradiation required to meet sterility standards.

    Product
    BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2340-2017·2017-07-19

    Oscor ATAR Reusable Extension Cables Recalled for Connector Separation Risk

    Oscor, Inc. is recalling ATAR Reusable Extension Cables because they may separate from the connector during use, posing a risk to patients.

    Product
    ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ATAR 53912 Reusable Series, and XI Reusable Series. Model codes: 53912 - MDTS ATAR REUSABLE, 53912A - MDTS ATAR REUSABLE, ATAR MDTS REUSABLE, ATAR-A DARK BLUE REUSABLE, ATAR-MDT REUSABLE, ATAR-MDT2…
    Category
    Medical Device
    Distribution
    39 states
  • SevereFDA (Devices)·Z-2733-2017·2017-07-19

    Oscor ATAR Disposable Extension Cables Recalled for Connector Separation Risk

    Oscor, Inc. is recalling ATAR Disposable Extension Cables because they may separate from the connector during use, posing a risk to patients.

    Product
    ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR 53912 Disposable Series, and XI Disposable Series. Model codes: ATAR D-A DARK BLUE DISPOSABLE, ATAR D-V WHITE DISPOSABLE, ATAR D-MDT DISPOSABLE, ATAR D-T DISPOSABLE, ATAR D-R DISPOSABLE…
    Category
    Medical Device
    Distribution
    39 states
  • HighFDA (Devices)·Z-2705-2017·2017-07-19

    O-Two Adult Ventilation Timer Recalled Due to Flash Rate Malfunction

    O-Two Medical Technologies is recalling Adult Ventilation Timers because the flash rate may be twice the labeled rate, potentially affecting ventilation guidance.

    Product
    O-Two Adult Ventilation Timer, MODEL #(s): 01BM1000-CS, 01BM3201-MOTP-CS, 01BM3201-MOTL-CS, CATALOG #(s): 01BM1000 --- INTENDED USE: The Adult Ventilation Timer is intended to guide the rescuer to provide ventilations at a rate appropriate for adult patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2729-2017·2017-07-19

    Natus Neurology Recalls Elite 5 MHz Vascular Probes Due to Noise Issues

    Natus Neurology is recalling 2,335 Elite 5 MHz Vascular Probes because excessive background noise may mask heart rate and blood flow signals.

    Product
    Nicolet¿ Elite¿ 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2695-2017·2017-07-19

    St. Jude Medical Recalls Infinity 7 Implantable Pulse Generators

    St. Jude Medical is recalling 373 Infinity 7 Implantable Pulse Generators because exposure to monopolar electrosurgical devices may cause a loss of neuromodulation therapy.

    Product
    Infinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2679-2017·2017-07-19

    ICU Plum A+ Infusion Systems Recalled for Battery-Related Therapy Interruption

    ICU is recalling Plum A+ Infusion Systems because battery issues can cause an E321 error code, potentially interrupting therapy.

    Product
    The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are…
    Category
    Medical Device
    Distribution
    Distributed nationwide