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.

Filters

Agency

Category

Minimum severity

Clear filters

19301–19325 of 27682

  • HighFDA (Devices)·Z-3033-2017·2017-08-23

    Cenorin ThermaSure Medical Device Dryers Recalled for Overheating Terminal Block

    Cenorin, LLC is recalling 43 ThermaSure Series 300 medical device dryers because a manufacturing defect causes the terminal block to overheat, char, or burn.

    Product
    ThermaSure(TM), a CENORIN(TM) product, SERIES 300 MEDICAL DEVICE DRYER: (a) Model 330; (b) Model 340 Forced air dryer for medical devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3020-2017·2017-08-23

    Cyberonics Recalls VNS Therapy Generators Due to Reduced Longevity

    Cyberonics is recalling 1,909 VNS Therapy AspireHC and AspireSR generators because a manufacturing defect may cause them to lose battery life faster than expected.

    Product
    VNS Therapy¿ AspireHC¿ Generator, VNS Therapy¿ AspireSR¿ Generator. Model No. 106. Product Usage: United States Indications for Use: Epilepsy (PMA 970003): The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2099-2017·2017-08-16

    Cook Medical Recalls Zenith Alpha Thoracic Endovascular Grafts

    Cook Medical is recalling Zenith Alpha Thoracic Endovascular Grafts due to reports of graft thrombosis and occlusion, including one patient death.

    Product
    Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2871-2017·2017-08-16

    Sorin Group Aortic Arch Cannula Recalled for Excess Plastic on Tip

    Sorin Group USA, Inc. is recalling Aortic Arch Cannulas due to the identification of excess plastic on the tip of the device.

    Product
    Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2832-2017·2017-08-16

    FDA Recalls Piston Syringes and Hypodermic Needles Due to Sterility Documentation Issues

    International Medsurg Connection, Inc. is recalling 54,204,100 piston syringes and hypodermic needles nationwide because of insufficient documentation to support product sterility claims.

    Product
    Piston Syringe and Hypodermic Needle, 3 CC L/L 22 G X 1.0, 100 per box, 24 boxes/case, 2,400/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2897-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Set Screws for Quality System Non-Compliance

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Set Screws because they are not consistent with FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Set Screw. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2872-2017·2017-08-16

    C.R. Bard Recalls Leg Bags Due to Potential Sterile Barrier Breach

    C.R. Bard is recalling 2,350 units of Bard Dispoz-A-Bag leg bags due to a reported cut in the side that may compromise the sterile barrier.

    Product
    BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in thermoformed trays. There are 50 units per case. Product Usage: Vinyl leg bag to be used with male external catheters, Foley catheters, or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2810-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling 54,204,100 hypodermic needles because the company lacks sufficient documentation to support the product's sterility claims.

    Product
    Hypodermic Needle, 20 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2821-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection is recalling 54,204,100 hypodermic needles because the company lacks sufficient documentation to support product sterility claims.

    Product
    Hypodermic Needle, 27 G X 1.0 in DISP HYPO, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2910-2017·2017-08-16

    Valorem Surgical Recalls Pallas M/MAXIMIS Polyaxial Spinal Screws

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS polyaxial screws due to quality system non-compliance. The devices are intended for spinal fixation.

    Product
    PALLAS M/MAXIMIS Polyaxial Screw and MIS Screw, 5.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2812-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling hypodermic needles because the company lacks sufficient documentation to support product sterility claims.

    Product
    Hypodermic Needle, 21 G X 1.0 in REG BEVEL, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2898-2017·2017-08-16

    Valorem Surgical Recalls Pallas M Pedicle Screws for Quality System Issues

    Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with FDA Quality System Requirements.

    Product
    PALLAS M/MAXIMIS Poly Screw 5.5 x 30mm. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2813-2017·2017-08-16

    FDA Recalls Hypodermic Needles Due to Insufficient Sterility Documentation

    International Medsurg Connection, Inc. is recalling hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.

    Product
    Hypodermic Needle, 21 G X 1.5 in YALE DISP, 100 per box, 50 boxes/case, 5,000/case The products are used to inject fluids into, or withdraw fluids from the body. They are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2779-2017·2017-08-09

    Myelotec Video Guided Catheters Recalled for Defective Access Port Body

    Myelotec, Inc. is recalling 2,980 Video Guided Catheters because a defective Access Port Body component can cause the port to become obstructed or blocked.

    Product
    Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2791-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a risk of sterile barrier breach.

    Product
    STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2796-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes that compromise sterility.

    Product
    NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2869-2017·2017-08-09

    In2Bones Recalls Non-Locking Orthopedic Screws Due to Perioperative Breakage

    In2Bones, SAS is recalling specific non-locking orthopedic screws after customer complaints reported breakage during insertion into the radius bone.

    Product
    Non-Locking screws in the following lengths: (a) NEO(R) 0.27 - 10 mm, REF W27 ST010 (b) NEO(R) 0.27 - 12 mm, REF W27 ST012 (c) DRP 0.27 - 12 mm, REF W27 ST012 (d) NEO(R) 0.27 - 14 mm, REF W27 ST014 (e) NEO(R) 0.27 - 16 mm, REF W27 ST016 (f) NEO(R) 0.27 - 18 mm, REF W27…
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2793-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a potential sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2868-2017·2017-08-09

    Zimmer Biomet Recalls ROSA Brain Surgical Navigation Systems

    Zimmer Biomet is recalling 20 ROSA Brain surgical navigation systems because the head holder connector may lock up mechanically when tightened.

    Product
    ROSA Brain, 3.0.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-2864-2017·2017-08-09

    Hologic Tomcat Instrument Recalled for Software Anomaly Affecting Sample Processing

    Hologic is recalling 164 Tomcat Instruments due to a software anomaly that may cause the pipettor arm to contact the mucous shelf, potentially leading to incorrect patient results.

    Product
    Tomcat Instrument, REF ASY-07379, Hologic Incorporated, automated laboratory sample processing instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2797-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a potential sterile barrier breach.

    Product
    NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2787-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included display sets may have packaging pinholes that compromise sterility.

    Product
    SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2798-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because they may contain Medtronic display sets with packaging pinholes that could breach the sterile barrier.

    Product
    NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2795-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled for Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have packaging pinholes, creating a risk of sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2792-2017·2017-08-09

    LivaNova Perfusion Tube Sets Recalled Due to Potential Sterile Barrier Breach

    LivaNova is recalling Perfusion Tube Sets because included Medtronic display sets may have pinholes in their packaging, creating a potential sterile barrier breach.

    Product
    SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA
    Category
    Medical Device
    Distribution
    Distributed nationwide