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

426–450 of 582

CriticalFDA (Devices)·Z-1275-2019·2019-05-22
Ethicon Intraluminal Staplers Recalled for Insufficient Firing Stroke
Ethicon Endo-Surgery is recalling 434,614 Straight Intraluminal Staplers (Model SDH21A) because they may have an insufficient firing stroke to break the washer and completely form staples.
Product
Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available in four sizes to permit proper matching of instrument to diameter of the lumen. The instrument permits tissue attachment to the
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1116-2019·2019-05-01
Edwards Lifesciences Recalls Fogarty Dilation Atrioseptostomy Catheters
Edwards Lifesciences is recalling Fogarty Dilation Atrioseptostomy Catheters due to reports of balloon fragmentation or detachment and difficulty deflating the balloon after deployment.
Product
Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atrioseptostomy catheter is designed for enlarging interatrial openings. In most pediatric cardiology centers, balloon atrioseptostomy is an ac
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0977-2019·2019-04-10
O-Two Medical e600 Ventilator Recalled for Fire Risk
O-Two Medical is recalling 119 e600 Automatic Transport Ventilators because a manufacturing defect may cause the unit to catch fire.
Product
e600 Automatic Transport Ventilator, Model Number 01EVE600
Category
Medical Device
Distribution
8 states
CriticalFDA (Devices)·Z-0805-2019·2019-03-06
ICU Medical Recalls ChemoLock Vial Spike Due to Potential Burr Particulate
ICU Medical is recalling one lot of ChemoLock Vial Spike devices due to a potential for containing burr particulate. The recall covers 2,050 units distributed in the US and internationally.
Product
icumedical ChemoLock Vial Spike, 20mm, REF CL-80S The ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the sy
Category
Medical Device
Distribution
7 states
CriticalFDA (Devices)·Z-0787-2019·2019-02-13
CoaguChek XS PT Test Strips Recalled for Abnormally High INR Results
Terrific Care LLC is recalling CoaguChek XS PT Test Strips sold via MedEx Supply due to potential for abnormally high INR test results.
Product
CoaguChek XS PT Test; All Catalog/REF Numbers that do NOT end in 160 The CoaguChek XS PT test strips are part of the CoaguChek XS System. The CoaguChek XS System is intended for properly selected and suitably trained users or their caregivers on the prescription or other order
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0715-2019·2019-02-13
Smiths Medical Recalls Portex Sterile Water Humidifiers Due to Leaking
Smiths Medical is recalling Portex 550 ml Sterile Water Humidifiers because leaking containers may compromise sterility, potentially exposing patients to infectious agents.
Product
Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿¿ ¿¿¿ ¿¿¿
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0710-2019·2019-02-13
Smiths Medical Recalls Portex Sterile Water Humidifiers Due to Leaking
Smiths Medical is recalling Portex 350 ml Sterile Water Humidifiers because leaking containers may expose patients to infectious agents.
Product
Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0722-2019·2019-02-13
Medline Prefilled 550 ml Sterile Bags Recalled for Leaking
Medex Cardio-Pulmonary Inc. is recalling 54,924 Medline Prefilled 550 ml Sterile bags due to leaking containers that may compromise sterility.
Product
Medline Prefilled 550 ml Sterile¿¿ ¿
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0711-2019·2019-02-13
Smiths Medical Recalls Portex Sterile Water Humidifiers Due to Leaking
Smiths Medical is recalling Portex 550 ml Sterile Water Humidifiers because leaking containers may compromise sterility, potentially exposing patients to infectious agents.
Product
Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0712-2019·2019-02-13
Smiths Medical Recalls Portex Sterile Water Pour Bottles Due to Leaking
Smiths Medical is recalling Portex 1000 ml Sterile Water USP Pour Bottles because leaking containers may lack sterility assurance, posing a risk of exposure to infectious agents.
Product
Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0764-2019·2019-02-06
Edwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Assembly Error
Edwards Lifesciences is recalling 9 units of Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings.
Product
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-0765-2019·2019-02-06
Edwards Lifesciences Recalls Swan Ganz Catheters Due to Lumen Reversal
Edwards Lifesciences is recalling 459 Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings, potentially leading to misdiagnosis.
Product
Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer.
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-0737-2019·2019-01-30
Draeger Medical Recalls VentStar Basic 250 Breathing Circuits Due to Assembly Error
Draeger Medical is recalling 170 units of VentStar Basic 250 breathing circuits because they were incorrectly pre-assembled, creating a risk of incorrect connection or short circuiting.
Product
VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with
Category
Medical Device
Distribution
12 states
CriticalFDA (Devices)·Z-0552-2019·2019-01-09
Medtronic StealthStation Cranial Software Recall for Biopsy Depth Gauge Error
Medtronic is recalling StealthStation Cranial and Synergy Cranial software due to an incorrect display of the Biopsy Depth Gauge that resulted in the biopsy of healthy tissue.
Product
StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc.
Category
Medical Device
Distribution
51 states
CriticalFDA (Devices)·Z-0269-2019·2018-11-14
OriGen Reinforced Dual Lumen Cannula Recalled for Potential Tube Separation
OriGen Biomedical is recalling 134 units of the VV19F Reinforced Dual Lumen Cannula because the extension tube may separate from the hub, posing a risk of blood loss.
Product
REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extra
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0188-2019·2018-10-31
Alcon Recalls CyPass Micro-Stent Implant Due to Endothelial Cell Loss
Alcon is recalling the CyPass Micro-Stent implant because long-term study data showed statistically significant endothelial cell loss in patients who received the device.
Product
CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. For ophthalmic use.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-3012-2018·2018-09-26
Ventana Recalls CINtec p16 Histology Reagent Due to Dispenser Defects
Ventana Medical Systems is recalling 468 units of CINtec p16 Histology reagent because leaking dispensers may cause false negative test results.
Product
CINtec p16 Histology (250), Catalog Number 06695230001, Model 725-4713 Immunohistochemistry (IHC) for in vitro diagnostic use.
Category
Medical Device
Distribution
0 states
CriticalFDA (Devices)·Z-2250-2018·2018-06-27
Draeger Fabius GS Premium Anesthesia Machine Recalled for Hypoxia Risk
Draeger Medical is recalling 62 Fabius GS Premium Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients.
Product
Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fa
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2253-2018·2018-06-27
Draeger Apollo Anesthesia Machine Recalled for Potential Hypoxic Gas Delivery
Draeger Medical is recalling 72 Apollo Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients, posing a risk of death.
Product
Apollo Anesthesia Machine; Cat. no. 8605310 Product Usage: Indicated as a continuous flow anesthesia system. The Apollo may be used for manually assisted or automatic ventilation, delivery of gases and anesthetic vapor, and monitoring of oxygen and CO2 concentration, breathin
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2251-2018·2018-06-27
Draeger Fabius GS Tiro Anesthesia Machine Recalled for Hypoxia Risk
Draeger Medical is recalling 31 Fabius GS Tiro anesthesia machines because a fault could allow 100% nitrous oxide delivery, creating a risk of hypoxic mixtures and patient death.
Product
Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabiu
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2252-2018·2018-06-27
Draeger Fabius GS MRI Anesthesia Machine Recalled for Hypoxia Risk
Draeger Medical is recalling four Fabius GS MRI Anesthesia Machines because a fault could allow the device to deliver a hypoxic gas mixture to patients, potentially causing death.
Product
Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1774-2018·2018-05-23
Abbott HeartMate 3 LVAS Implant Kit Recalled for Graft Occlusion Risk
Abbott is recalling HeartMate 3 LVAS Implant Kits due to reports of outflow graft twist occlusions that can cause serious adverse events.
Product
Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.
Category
Medical Device
Distribution
35 states
CriticalFDA (Devices)·Z-0587-2018·2018-02-28
Medtronic Recalls Evera ICDs Due to Possible Therapy Prevention
Medtronic is recalling 951 Evera ICDs and CRT-Ds because a defect may prevent the devices from delivering high or low voltage therapy.
Product
Implantable Cardioverter Defibrillators (ICDs), Evera. Labeled as the following: a. Evera S DR ICD DF1 (Product No. DDBC3D1); b. Evera S VR ICD DF1 (Product No. DVBC3D1); c. Evera S VR ICD DF4 (Product No. DVBC3D4); d. Evera XT DR ICD DF1 (Product No. DDBB1D1); e. E
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0583-2018·2018-02-28
Medtronic Recalls Compia MRI CRT-Ds Due to Therapy Prevention Risk
Medtronic is recalling 951 Compia MRI CRT-Ds because a defect may prevent the delivery of high and low voltage therapy.
Product
Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), Compia MRI. Labeled as the following: a. Compia MRI CRT-D DF1 (Product No. DTMC1D1); b. Compia MRI Quad CRT-D DF4 (Product No.DTMC1QQ ) Implantable devices that automatically detect and treat episodes of ventric
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 r
Category
Medical Device
Distribution
Distributed nationwide

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426–450 of 582