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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Any3+ (High and above)4+ (High and above)5+ (High and above)

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19401–19425 of 27682

  • HighFDA (Devices)·Z-2722-2017·2017-07-19

    ICU Medical Recalls 10-Inch Smallbore Extension Sets Due to Leak Risk

    ICU Medical is recalling 900 units of 10-inch smallbore extension sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.

    Product
    10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2724-2017·2017-07-19

    ICU Medical Recalls 10-Inch Smallbore Extension Sets Due to Leak Risk

    ICU Medical is recalling 100 units of 10-inch smallbore extension sets because the connection between the Female Luer and the NanoClave manifold may develop a leak.

    Product
    10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2716-2017·2017-07-19

    ICU Medical Recalls 18 cm Smallbore Extension Sets Due to Leak Risk

    ICU Medical is recalling 304 units of 18 cm Smallbore Extension Sets because the connection between the Female Luer and NanoClave manifold may leak.

    Product
    18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2732-2017·2017-07-19

    Nova Biomedical Stat Profile Prime Analyzer Software Recall

    Nova Biomedical is recalling Stat Profile Prime Analyzers because a software defect could cause scheduled quality control tests to overwrite pending patient results.

    Product
    Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profile Prime ABG Analyzer PN 53655 Stat Profile Prime ABG Analyzer with Scanner PN 52856 Stat Profile Prime CCS Analyzer PN 53656 Stat Profile Prime CCS Analyzer with Scanner PN 53657 Stat Profile Prime…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2693-2017·2017-07-19

    St. Jude Medical Recalls Infinity 5 Implantable Pulse Generators

    St. Jude Medical is recalling 443 Infinity 5 Implantable Pulse Generators due to a risk of losing neuromodulation therapy when exposed to monopolar electrosurgical devices.

    Product
    Infinity 5, Implantable Pulse Generator, REF 6660, 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-2683-2017·2017-07-19

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

    ICU is recalling 363,892 Plum A+ Infusion Systems because battery issues can cause an E321 error code, potentially interrupting patient 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
  • HighFDA (Devices)·Z-2692-2017·2017-07-19

    St. Jude Medical Recalls Proclaim 7 Elite Implantable Pulse Generators

    St. Jude Medical is recalling 9,529 Proclaim 7 Elite implantable pulse generators due to a risk of losing neuromodulation therapy when exposed to monopolar electrosurgical devices.

    Product
    Proclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2712-2017·2017-07-19

    Toshiba APLIO i-series Ultrasound Systems Recalled for Incorrect Velocity Readings

    Toshiba is recalling 28 APLIO i-series diagnostic ultrasound systems because they may display incorrect velocity values when using the Continuous Trace method.

    Product
    APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2714-2017·2017-07-19

    ArjoHuntleigh Flowtron ACS900 Medical Pump Recalled for Deflation Failure

    Arjo, Inc. is recalling 40,675 Flowtron ACS900 medical pumps worldwide because the device may fail to deflate the calf garment as intended without triggering an alarm.

    Product
    ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099 Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk patients. The system must be used as part of a prescribed plan of car under the supervision of trained medical and/or Clinical staff.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2698-2017·2017-07-19

    Arrow Recalls EVOLUTION Pressure Injectable PICC Catheters Due to Hub Tab Detachment

    Arrow International is recalling EVOLUTION Pressure Injectable PICC catheters because the peel-away component hub tabs may prematurely detach during use.

    Product
    Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-2721-2017·2017-07-19

    ICU Medical Recalls MicroClave Extension Sets Due to Leak Risk

    ICU Medical is recalling 100 units of MicroClave extension set kits because the connection between the Female Luer and the NanoClave manifold may develop a leak.

    Product
    Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patients vascular system through the administration sets needle or catheter…
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-2727-2017·2017-07-19

    Natus Neurology Recalls Elite Obstetric Probes Due to Excessive Background Noise

    Natus Neurology is recalling 2,335 Elite Obstetric probes because excessive background noise may mask fetal heart rate and blood flow monitoring.

    Product
    Nicolet¿ Elite¿ 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20. 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
  • SevereFDA (Devices)·Z-2657-2017·2017-07-12

    CardioTek EP-TRACER Software Recalled for Unintentional Parameter Changes

    CardioTek BV is recalling EP-TRACER Software V1.x and V2.0 due to a bug that allows parameters to be changed unintentionally during use.

    Product
    CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2667-2017·2017-07-12

    Exactech Equinoxe Reamer Recalled for Updated Instructions on Glenoid Reaming

    Exactech is recalling the Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer to update instructions for use, clarifying proper reaming technique to prevent instrument breakage.

    Product
    EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-2684-2017·2017-07-12

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems Due to Software Issue

    Ion Beam Applications S.A. is voluntarily recalling six Proteus 235 Proton Therapy Systems worldwide due to a software issue. Five of these units are located in the United States.

    Product
    Proteus 235, Proton Therapy System Product Usage: The Proton Therapy System - Proteus 235 is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2688-2017·2017-07-12

    Siemens Sensis Vibe Systems Recalled for Software Error in Report Generation

    Siemens is recalling 13 Sensis Vibe diagnostic computers in the US due to a software error that may combine patient data from different examinations into a single report.

    Product
    Sensis Vibe Systems with Software Version VD10B, Model Numbers 10765502, 10910620, 11007641, 6648161 --- Programmable diagnostic computer,
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2670-2017·2017-07-12

    Smiths Medical Recalls Hypodermic Needles Due to Syringe Hub Defects

    Smiths Medical is recalling specific lots of Jelco Hypodermic Needle Pro needles because syringe assemblies used in their manufacture contained pin holes in the hub.

    Product
    Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2685-2017·2017-07-12

    PerkinElmer Multiphor II Electrophoresis System Recalled for Electric Shock Risk

    PerkinElmer is recalling 241 Multiphor II Electrophoresis Systems due to a potential electric shock hazard if grommets are not installed.

    Product
    Multiphor II Electrophoresis System GE HealthCare Product Number: 18-1018-06 PerkinElmer Part Number: 2117-004 Product Usage: Multiphor II Electrophoresis System is a versatile modular electrophoresis system for horizontal electrophoresis, isoelectric focusing, 2-D…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2656-2017·2017-07-12

    JAS Diagnostics Recalls Drew Scientific DREW 3-PAC Reagent Kits

    JAS Diagnostics Inc. is recalling 14,064 units of Drew Scientific DREW 3-PAC Reagent Kits because they may result in elevated platelet backgrounds during routine startup checks.

    Product
    Drew Scientific DREW 3-PAC Reagent Kit containing: 5L Diluent, 750 mL Enzymatic Cleaner, and 125 mL Lysing Reagent.
    Category
    Medical Device
    Distribution
    18 states
  • SevereFDA (Devices)·Z-2639-2017·2017-07-05

    DeRoyal Dolphin Inflation Device Recalled for Sterility Assurance Defect

    DeRoyal Industries is recalling 426 Dolphin Inflation Devices due to a primary packaging defect that may compromise sterility.

    Product
    DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2626-2017·2017-07-05

    EOS Imaging Recalls ROTH MOBELI Grab Handles for Detachment Risk

    EOS Imaging is recalling ROTH MOBELI grab handles because they could detach, posing a fall risk to patients if operators do not follow instructions.

    Product
    ROTH MOBELI Grab Handles used with EOS System: MOBELI Stabi Vario Grab Handle, ROTH Catalogue Number 14002 96 S, EOS Imaging Catalogue Number 9000111773; and MOBELI Dual Grip Grab Handle, ROTH Catalogue Number 14002 25 S, EOS Imaging Catalogue Number 9000111774.
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-2629-2017·2017-07-05

    Olympus Recalls High Frequency Resection Electrodes Due to Wire Breakage

    Olympus Corporation of the Americas is recalling 1,264 High Frequency Resection Electrodes because loop wires may break at the distal end.

    Product
    High Frequency Resection Electrodes, endoscope, ac-powered and accessories The electrodes are used for endoscopic diagnosis and treatment in urological and gynecological applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide