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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Minimum severity

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

Clear filters

11951–11975 of 27470

  • SevereFDA (Devices)·Z-1192-2021·2021-03-24

    Medtronic Recalls Custom Perfusion System Due to Endotoxin Risk

    Medtronic Perfusion Systems is recalling three units of its Custom Perfusion System because they may contain elevated levels of bacterial endotoxins. Patients exposed to these devices could develop an acute inflammatory response.

    Product
    Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1263-2021·2021-03-24

    Heartspan Transseptal Needle Recall Due to Tip Curvature Mismatch

    Merit Medical Systems is recalling Heartspan Transseptal Needles because the labeled tip curvature may not match the actual curvature, posing a risk of unintended anatomy puncture.

    Product
    Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock attached to the proximal end. The stylet consists of a…
    Category
    Medical Device
    Distribution
    18 states
  • SevereFDA (Devices)·Z-1197-2021·2021-03-24

    Medtronic Affinity Pixie Cardiotomy Reservoir Recalled for Bacterial Endotoxin

    Medtronic is recalling 5 units of Affinity Pixie Cardiotomy Reservoirs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.

    Product
    Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1264-2021·2021-03-24

    Imactis NaviKit Stereotaxic Accessory Recalled for Mechanical Defect

    Imactis is recalling 105 NaviKit-stereotaxic accessories due to a mechanical defect in the needle holder that may cause inaccurate needle positioning during use.

    Product
    Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1190-2021·2021-03-24

    Medtronic Affinity Pixie Oxygenator Recalled for Bacterial Endotoxin

    Medtronic is recalling Affinity Pixie Oxygenators due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses in patients.

    Product
    Medtronic Affinity Pixie Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 AFFINITY PIXIE WCVR OU). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1269-2021·2021-03-24

    Canon Catheterization Table Recall Due to Potential Tilt Hazard

    Canon is recalling 145 INTERVENTIONAL ANGIOGRAPHY SYSTEMS because table fastening bolts may loosen, causing the table to tilt.

    Product
    Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1199-2021·2021-03-24

    Medtronic Recalls Custom Perfusion System Due to Endotoxin Risk

    Medtronic Perfusion Systems is recalling 7 units of the Custom Perfusion System because they may contain elevated levels of bacterial endotoxins, which can cause acute inflammatory responses in patients.

    Product
    Custom Perfusion System (CUSTOM PACK BB7W03R8 CCSM NEON). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1274-2021·2021-03-24

    Siemens HSV-2 Test Kits Recalled for Potential False Positive Results

    Siemens is recalling ADVIA Centaur4P Herpes-2 IgG test kits due to stability and calibration failures that may cause false positive results.

    Product
    Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1273-2021·2021-03-24

    Philips CT Systems Recalled for Potential Couch Movement Failure

    Philips is recalling 109 CT systems because a defect in the Incisive CT couch actuators could cause the couch to fail to self-lock and move downward unexpectedly.

    Product
    Philips CT systems are advanced continuous-rotation computed tomography systems suitable for a wide range of computed tomographic (CT) applications - Product Usage: intended for use in the head and whole body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1194-2021·2021-03-24

    Medtronic Affinity Pixie Cardiotomy Reservoir Recalled for Bacterial Endotoxin

    Medtronic is recalling 10 units of the Affinity Pixie Cardiotomy/Venous Reservoir due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.

    Product
    Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1276-2021·2021-03-24

    Epimed Feth-R-Kath Catheter Recalled for Coating Deterioration

    Epimed International is recalling Feth-R-Kath Catheters because the outer coating may crack or flake off. The recall covers 5,835 units distributed nationwide.

    Product
    Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or less
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1253-2021·2021-03-24

    Siemens SOMATOM CT Software Recall for Workflow Interruptions

    Siemens is recalling specific software versions for SOMATOM CT systems due to sporadic errors that may interrupt scanning workflows and delay diagnosis.

    Product
    Software versions syngo.CT VA30A_SP2 or syngo.CT VA30A_SP2a in the Computed tomography systems as follows: SOMATOM go.Now (Model 11061610)SOMATOM go.Up (Models 11061620 & 11061628) SOMATOM go.All (Model 11061630) SOMATOM go.Top (Models 11061640 & 11061648) SOMATOM go.Sim…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1265-2021·2021-03-24

    Philips Incisive CT System Recalled for Gantry Actuator Failure Risk

    Philips is recalling 105 Incisive CT Computed Tomography X-ray Systems because gantry actuators may fail, causing the gantry to tilt forward.

    Product
    Incisive CT Computed Tomography X-ray System Model: 728143
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1254-2021·2021-03-24

    Mindray BeneVision Distributed Monitoring System Recalled for Intermittent Freezes

    Mindray is recalling 1,938 BeneVision Distributed Monitoring Systems because they may intermittently freeze, causing telemetry data to stop communicating to the central system.

    Product
    Mindray BeneVision Distributed Monitoring System( DMS) 1. p/n 115-051209-00 2. p/n 115-034414-00 and 115-034413-00 when used with the following software versions: 03.04.00 04.01.00 04.03.00 04.04.00 04.04.01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1272-2021·2021-03-24

    Accuray CyberKnife Treatment Delivery System Recalled for Loose Set Screws

    Accuray is recalling 243 CyberKnife Treatment Delivery Systems because set screws can loosen, allowing the treatment couch to roll unexpectedly.

    Product
    CyberKnife Treatment Delivery System - Product Usage: indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1191-2021·2021-03-24

    Medtronic Affinity Pixie Oxygenator Recalled for Bacterial Endotoxin

    Medtronic is recalling 57 units of Affinity Pixie oxygenators due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.

    Product
    Medtronic Affinity Pixie BP241 Hollow Fiber Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (OXYGENATOR BBP241 W/CVR NI BB STERILE). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1267-2021·2021-03-24

    Ortho-Clinical VITROS SARS-CoV-2 Antigen Reagent Pack Recall for False Results

    Ortho-Clinical Diagnostics is recalling VITROS SARS-CoV-2 Antigen Reagent Packs used with Remel M4RT Viral Transport Media due to potential false reactive results.

    Product
    VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent immunoassay intended for the qualitative detection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1270-2021·2021-03-24

    Canon Medical Recalls Catheterization Tables Due to Potential Tilt Hazard

    Canon Medical System is recalling 145 INTERVENTIONAL ANGIOGRAPHY SYSTEMS because loose bolts may cause the table to tilt.

    Product
    Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1268-2021·2021-03-24

    Carestream Dental CS 3600 Tips Recalled for Detachment Risk

    Carestream Dental is recalling CS 3600 Single Use Normal Tips because the mirror may become detached and fall from the unit.

    Product
    Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of teeth or dental impressions in three dimensions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1193-2021·2021-03-24

    Medtronic Infant Tubingset Recalled for Elevated Bacterial Endotoxin Levels

    Medtronic is recalling 14 units of infant tubingsets due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.

    Product
    Medtronic Custom Pack Infant Tubingset Pixie Flow 0,8->1,5-1,8 1/B (PERFUSION M483203D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1275-2021·2021-03-24

    Sirtex Medical Recalls SIROS D-Vial Prep Sets Due to Particulate Matter

    Sirtex Medical Limited is recalling SIROS D-Vial Prep Sets because of a potential presence of particulate matter in the D-Vial.

    Product
    SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1257-2021·2021-03-24

    Cordis Precise Pro RX Carotid Stent Recall for Tip Separation

    Cordis is recalling Precise Pro RX Carotid Stent implant systems because the distal tip may separate from the lumen wire.

    Product
    PRECISE PRO RX CAROTID STENT implant system, Product Codes: PC0520RXC, PC0530RXC, PC0540RXC, PC0620RXC, PC0630RXC, PC0640RXC, PC0720RXC, PC0730RXC, PC0740RXC, PC0820RXC, PC0830RXC, PC0840RXC, PC0920RXC, PC0930RXC, PC0940RXC, PC1030RXC, PC1040RXC
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1198-2021·2021-03-24

    Medtronic Pediatric Cardiotomy Reservoir Recalled for Bacterial Endotoxin

    Medtronic is recalling 4 units of a pediatric cardiotomy reservoir due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.

    Product
    Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1271-2021·2021-03-24

    Canon Catheterization Table Recall Due to Potential Tilt Hazard

    Canon Medical System is recalling 145 interventional angiography systems because the table may tilt if fastening bolts become loose.

    Product
    Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen, and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1266-2021·2021-03-24

    Ortho-Clinical VITROS SARS-CoV-2 Antigen Reagent Recalled for False Results

    Ortho-Clinical Diagnostics is recalling VITROS SARS-CoV-2 Antigen Reagents because they may produce false reactive results when used with Remel M4RT Viral Transport Media.

    Product
    VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent- In Vitro Diagnostic. The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Reagent Pack when used in combination with the VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator is a chemiluminescent…
    Category
    Medical Device
    Distribution
    Distributed nationwide