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 deaths or serious injuries are reported, 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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

3201–3225 of 5038

SevereFDA (Devices)·Z-2791-2018·2018-08-22
Cook Inc. Recalls VentriClear Ventricular Drainage Catheter Sets Due to Endotoxin Failure
Cook Inc. is recalling 250 units of the VentriClear Ventricular Drainage Catheter Set because the product failed endotoxin testing. The recall involves one distributor in Indiana, and the product was not distributed to end users.
Product
VentriClear Ventricular Drainage Catheter Set, Cat. No. N-VVDC-01-ABRM Product Usage: The VentriClear Ventricular Drainage Catheter Set has been designed for obtaining access to a ventricular cavity of the brain for short-term use to externally drain fluid for the purpose of
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2811-2018·2018-08-22
ICU Medical Recalls Smallbore I.V. Administration Sets Due to Leak Risk
ICU Medical is expanding a recall of specific smallbore I.V. administration sets because they may leak or separate at the manifold connection.
Product
61 cm (24") Smallbore Ext Set w/6-Port NanoClave Manifold, Check Valve, MicroClave Clear, 1.2 Micron Filter, 3 Gang 4-Way NanoClave Stopcock (Glow, Blue, Red Rings), Rotating Luer, 2 Ext.
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-2589-2018·2018-08-22
Spacelabs Arkon Anesthesia Delivery System Recalled for Ventilation Failure Risk
Spacelabs Healthcare is recalling 328 Arkon Anesthesia Delivery Systems because they may stop providing mechanical ventilation while in use or idle.
Product
Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Unit Assembly 650-1769-00 installed, and Model #: 99999. This system includes a ventilator. The Spacelabs Arkon Anesthesia Workstation is intended for use in the hospital environment and operating roo
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2824-2018·2018-08-22
Sorin Platinium CRT-D Recall Due to Pacing and Sensing Loss
Sorin CRM SAS is recalling 16 Platinium CRT-D devices because a hardware defect may cause loss of pacing and sensing, preventing the device from delivering necessary defibrillation.
Product
Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-2825-2018·2018-08-22
Sorin Platinium CRT-D Recall Due to Loss of Pacing and Sensing
Sorin CRM SAS is recalling 10 Platinium CRT-D devices because a hardware issue may cause loss of pacing and sensing, preventing the device from detecting arrhythmias.
Product
Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-2681-2018·2018-08-15
Howmedica Recalls rHead Stem Implant 6mm Collar Due to Revision Rate
Howmedica Osteonics Corp. is recalling 245 rHead Stem Implant 6mm Collar units because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Stem Implant 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2721-2018·2018-08-15
Howmedica Recalls rHead Recon Stem Implants Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 118 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Recon Stem Implant non-coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2734-2018·2018-08-15
Waterpik Sonic-Fusion Professional Recall Due to Charging Base Overheating
Water Pik, Inc. is recalling 3,797 Waterpik Sonic-Fusion Professional units because the charging base may overheat, melt, or spark, posing fire, shock, or burn risks.
Product
Waterpik Sonic-Fusion Professional, Model: SF-02 Product Usage: The device is composed of a unit base and an oral irrigator/ battery operated brush power handle. The device provides a pulsating stream of potable water and/or powered toothbrush action to remove plaque and food
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2738-2018·2018-08-15
Datex-Ohmeda Neonatal Flow Sensor Cable Recall for Missing Connector Housing
Datex-Ohmeda is recalling 417 Neonatal Flow Sensor Cables because the connector housing may be missing, exposing internal wires. The defect poses a risk of electrical shock or fire.
Product
The Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatric, and adu
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2553-2018·2018-08-15
Vyaire Medical Recalls Pediatric AirLife Resuscitation Devices Due to Airflow Obstruction Risk
Vyaire Medical is recalling 15,714 pediatric AirLife Resuscitation Devices because a manufacturing error may obstruct supplemental oxygen airflow during use.
Product
AirLife Resuscitation Device, Pediatric labeled as the following: a. Pediatric, with mask, 28" large bore tubing, pressure-relief valve, Part Number 2K8018; b. Pediatric, with mask, 40" oxygen reservoir bag, pressure-relief valve, Part Number 2K8008; c. Pediatric,
Category
Medical Device
Distribution
28 states
SevereFDA (Devices)·Z-2703-2018·2018-08-15
Howmedica Recalls rHead Radial Head Implants Due to Performance Concerns
Howmedica Osteonics Corp. is recalling 33 rHead Standard Extended Stem implants because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Standard Extended Stem, 6mm Collar, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2716-2018·2018-08-15
Howmedica Recalls Stryker rHead Radial Head Orthopedic Implants
Howmedica Osteonics Corp. is recalling 543 units of the #2 Bipolar stem implant from the Stryker rHead system due to higher-than-expected revision rates.
Product
#2 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2675-2018·2018-08-15
Howmedica Recalls Stryker Radial Head Implant Assemblies Due to Revision Rate
Howmedica Osteonics Corp. is recalling 191 Stryker rHead Radial Head implant assemblies because literature reviews indicate a higher revision rate than other similar devices.
Product
Lateral Assembly, Radial Head Impl Assembly, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2660-2018·2018-08-15
Arjohuntleigh Magog Quick Connect 272 KG Scale Recall for Detachment Risk
Arjohuntleigh Magog is recalling Quick Connect 272 KG Scales used with Maxi Sky 2 ceiling lifts because the spreader bar can detach from the scale attachment.
Product
Quick Connect 272 KG Scale used with Maxi Sky 2 ceiling lift The Scale is intended to be used with patient lifters to measure the weight of a patient who cannot stand on a scale. It is designed to be used indoors in hospitals, nursing homes, home care or health care facilities
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2725-2018·2018-08-15
Howmedica Recalls Radial Stem Implants Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 256 radial stem implants because literature reviews indicate higher revision rates than other similar devices.
Product
radial stem implant #1 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2712-2018·2018-08-15
Howmedica Recalls #3 Bipolar Radial Head Implant Due to Revision Rate
Howmedica Osteonics Corp. is recalling 999 units of the #3 Bipolar radial head implant because literature reviews indicate a higher revision rate than other similar devices.
Product
#3 Bipolar radial head Implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2685-2018·2018-08-15
Howmedica Recalls rHead Recon Stem Implants Due to Revision Rate Concerns
Howmedica Osteonics Corp. is recalling 314 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Recon Stem Implant Plasma Coated, Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2717-2018·2018-08-15
Howmedica Recalls rHead Recon Stem Implants Due to Revision Rate
Howmedica Osteonics Corp. is recalling 133 rHead Recon Stem Implants because the revision rate is higher than other similar devices, potentially affecting post-surgery performance.
Product
rHead Recon Stem Implant non-coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2736-2018·2018-08-15
FDA Recalls iTOVi Tracker/Scanner Devices Due to Shock Complaints
Hudson Scientific LLC is recalling iTOVi Tracker/Scanner devices because they may not meet manufacturing standards and have caused electric shocks.
Product
iTOVi Tracker/Scanner, Model Nos. ITS10 and ITS15 Intended to rank galvanic skin response measurements. The results are used by the software to generate a report that then makes a recommendation on nutritional supplements.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2686-2018·2018-08-15
Howmedica Recalls rHead Recon Stem Implant Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 303 rHead Recon Stem Implant Plasma Coated, Size 2 units because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Recon Stem Implant Plasma Coated, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2690-2018·2018-08-15
Howmedica Recalls rHead Recon Stem Implants Due to Higher Revision Rates
Howmedica Osteonics Corp. is recalling 269 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.
Product
rHead Recon Stem Implant 6mm Collar, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2594-2018·2018-08-08
Integra LifeSciences Recalls Mayfield Infinity XR2 Base Units Due to Fracture Risk
Integra LifeSciences is recalling Mayfield Infinity XR2 Low Profile Base Units because the knob assembly in the swivel adapter may fracture or break during use.
Product
MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2559-2018·2018-08-08
Galt Medical Recalls Vascular Dilators and Introducer Kits Due to Endotoxins
Galt Medical Corporation is recalling specific vascular dilators and introducer kits because they may contain unsafe levels of bacterial endotoxins introduced during manufacturing.
Product
1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11; 3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) INT-028-24; c) INT-029-05; d) INT-106-01; e) INT-106-14; 4) Micro-Access Te
Category
Medical Device
Distribution
19 states
SevereFDA (Devices)·Z-2563-2018·2018-08-08
Galt Medical Recalls Centeze Centesis Catheters Due to Bacterial Endotoxins
Galt Medical Corporation is recalling 300 units of Centeze Centesis Catheters because they may contain unsafe levels of bacterial endotoxins introduced during manufacturing.
Product
Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,
Category
Medical Device
Distribution
19 states
SevereFDA (Devices)·Z-2601-2018·2018-08-08
Polysorb Suture Recalled for Potential Propylene Glycol Contamination
Covidien LLC is recalling Polysorb Braided Absorbable Sutures due to potential propylene glycol contamination. The recall affects 972 units distributed in California, New York, and Texas.
Product
Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
Category
Medical Device
Distribution
3 states

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