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.

Agency

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

21126–21150 of 27682

HighFDA (Devices)·Z-2680-2016·2016-09-07
Waismed Recalls NIO-P Instant Intraosseous Access Devices Due to Malfunction
Waismed is recalling 50 units of NIO-P devices because a needle failed to release as expected during operation, posing a risk of injury.
Product
NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle into the bone marrow of a patient and allows connection of syringe or IV administration set. The NIO-A is intended for adults above 12 years old and the NIO-P…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-2687-2016·2016-09-07
Baxter Non-DEHP Micro-Volume Extension Set Recalled for Sterility Compromise
Baxter Healthcare is recalling 15,257 units of Non-DEHP Micro-Volume Extension Sets because improper sealing compromised product sterility.
Product
Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single use nonpyrogenic fluid pathway; 50 sets per case; For the administration of drugs and solutions to a patient's vascular system through a vascular access…
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-2710-2016·2016-09-07
BD Vacutainer Push Button Blood Collection Set Recalled for Barrel Separation
Becton Dickinson is recalling specific lots of BD Vacutainer Push Button Blood Collection Sets because the front and rear barrels may separate when the safety feature is activated.
Product
BD Vacutainer Push Button Blood Collection Set, Sterile, Rx only, 0.6 x 19 mm x 305 mm, 23G x 3/4" x 12", REF 367342.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2674-2016·2016-09-07
Nakanishi Diamond Coated Dental Tips Recalled for Missing Single-Use Labeling
Nakanishi Inc. is recalling 4,284 diamond coated dental tips because the packaging failed to indicate they are single-use only, posing a risk of cross-contamination.
Product
Diamond Coated Tips and Burs are accessories to the air powered dental handpiece (S-MAX pico) The intended use of the tips is based on the parent device. For burs used with the dental handpieces, the intended use is general dental actions such as removing carious material…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2712-2016·2016-09-07
Elekta Monaco RTP System Software Recall for Contour Deletion Error
Elekta, Inc. is recalling the Monaco RTP System software due to a defect where deleted contours may remain in treatment plans.
Product
Monaco RTP System Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Category
Medical Device
Distribution
40 states
HighFDA (Devices)·Z-2669-2016·2016-09-07
Philips Recalls Allura Xper Systems Due to Power Supply Failure Risk
Philips is recalling 1,536 Allura Xper medical imaging systems because certain low-voltage DC power supplies have an increased failure rate.
Product
Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027; Allura Xper FD20, 722028; Allura Xper FD20/10 biplane, 722029; Allura Xper FD10 OR Table, 722033; Allura Xper FD10/10 OR Table, 722034; Allura Xper FD20 OR Table, 722035; Allure Xper…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2705-2016·2016-09-07
Medical Vision Ab Recalls Double Pump RF Patient Cassettes
Medical Vision Ab is recalling 3,295 Double Pump RF Patient Cassettes because sterile package breakage may compromise device sterility.
Product
Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures.
Category
Medical Device
Distribution
22 states
SevereFDA (Devices)·Z-2358-2016·2016-08-31
Alere INRatio2 PT/INR Home Monitoring System Recalled for Inaccurate INR Results
Alere San Diego is voluntarily recalling INRatio2 PT/INR Home Monitoring Systems because they may display inaccurate INR results compared to central laboratory tests.
Product
Alere INRatio2 PT/INR Home Monitoring System Model Number: 0200432, 0200433 Product Usage: Alere INRatio 2 PT/INR Home Monitoring System: The Alere INRatio 2 PT/INR Home Monitoring System, consisting of the INRatio 2 Home Monitor and INRatio PT/INR test strip, is used for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2614-2016·2016-08-31
Cook Inc. Recalls Slip-Cath Beacon Tip Catheters Due to Tip Fracture
Cook Inc. is recalling Slip-Cath Beacon Tip Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.
Product
Slip-Cath Beacon Tip Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2597-2016·2016-08-31
Conmed Pediatric ThermoGard Electrodes Recalled for Burn Risk
Conmed is recalling Pediatric ThermoGard Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, posing a risk of undetected pad lift and potential burns.
Product
Pediatric ThermoGard¿ Dual Dispersive Electrodes (for patients 5-15 kg.), 10' (3.05m) Cable, Catalog Number 51-7710. Intended to be used for the dispersion and return to the electrosurgical generator.
Category
Medical Device
Distribution
45 states
SevereFDA (Devices)·Z-2651-2016·2016-08-31
Medtronic Evera ICDs Recalled for Rapid Battery Depletion Risk
Medtronic is recalling 78 Evera ICDs and Viva CRT-Ds due to a circuit defect causing rapid battery depletion. Seven confirmed failures have resulted in complications like shortness of breath.
Product
Medtronic, Evera Implantable Cardioverter Defibrillators: Product Model EVERA XT DDBB1D1, DDBB1D4, DDBB2D1, DDBB2D4, DVBB2D4, DVBB1D1. EVERA S DDBC3D1, DDBC3D4 Product Usage: The Medtronic Evera DR dual chamber and Evera VR single chamber, implantable…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2356-2016·2016-08-31
Alere INRatio PT Monitoring Systems Recalled for Inaccurate INR Results
Alere San Diego is voluntarily recalling INRatio PT Monitoring Systems because they may show lower INR results than central laboratory tests, potentially affecting warfarin therapy.
Product
Alere INRatio Replacement Monitor Model Number: 0100137 Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for use outside the body (in…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2623-2016·2016-08-31
Cook Inc. Recalls White Lumax Guiding Coaxial Catheters Due to Tip Fracture
Cook Inc. is recalling 3,425 White Lumax Guiding Coaxial Catheters worldwide due to polymer degradation that can cause the catheter tip to fracture or separate.
Product
White Lumax Guiding Coaxial Catheter Catheter, Percutaneous Intended for the delivery of angioplasty balloons and other types of interventional devices.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2616-2016·2016-08-31
Cook Inc. Recalls Haskal Transjugular Intrahepatic Portal Access Sets
Cook Inc. is recalling Haskal Transjugular Intrahepatic Portal Access Sets due to polymer degradation that can cause catheter tip fracture and separation.
Product
Haskal Transjugular Intrahepatic Portal Access Set Introducer, catheter Intended for transjugular liver access in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2666-2016·2016-08-31
Tecan Hydroflex ELISA Plate Washer Recalled for Battery Overheating Risk
Tecan US, Inc. is recalling Hydroflex ELISA plate washers because the batteries may overheat, melt, or char.
Product
Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well microplates. The instrument is intended to be used primarily in in-vitro diagnostic processing of samples from the human body to obtain information on physiological and pathological states. Software and instrument have…
Category
Medical Device
Distribution
19 states
SevereFDA (Devices)·Z-2610-2016·2016-08-31
Cook Inc. Recalls Beacon Tip Torcon NB Advantage Catheters Due to Tip Fracture
Cook Inc. is recalling Beacon Tip Torcon NB Advantage Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.
Product
Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2613-2016·2016-08-31
Cook Inc. Recalls Shuttle Select Slip-Cath Catheters Due to Tip Fracture
Cook Inc. is recalling 60,302 Shuttle Select Slip-Cath catheters worldwide due to polymer degradation causing tip fracture and separation.
Product
Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2620-2016·2016-08-31
Cook Inc. Recalls Aprima Access Nonvascular Introducer Sets Due to Tip Fracture
Cook Inc. is recalling Aprima Access Nonvascular Introducer Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to medical complications.
Product
Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for single-puncture percutaneous access to facilitate placement of an .038 inch (0.97 mm) diameter working wire guide for interventional radiology procedures
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2660-2016·2016-08-31
Tecan Infinite F50 Absorbance Reader Recalled for Battery Overheating Risk
Tecan US, Inc. is recalling Infinite F50 absorbance readers because the batteries may overheat, melt, or char.
Product
Infinite F50 instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to…
Category
Medical Device
Distribution
19 states
SevereFDA (Devices)·Z-2649-2016·2016-08-31
Bovie Precise 360 Handpiece Recalled Due to Incomplete Tip Bond
Bovie Medical Corporation is recalling 95 units of the BVX-450NR Bovie Precise 360 Handpiece because the adhesive bond to the angled tip may be incomplete.
Product
BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparoscopic surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2650-2016·2016-08-31
Medtronic Recalls 78 Viva Quadripolar Implantable Cardioverter Defibrillators
Medtronic is recalling 78 Viva Quadripolar Implantable Cardioverter Defibrillators because a circuit defect may cause rapid battery depletion. Seven confirmed failures have been reported.
Product
Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: Product Model VIVAXTCRT-D DTBA1D1, DTBA1D4 VIVASCRT-D DTBB1D1, DTBB1D4 Product Usage: The Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2537-2016·2016-08-31
Cook Inc. Recalls Roadrunner Uniglide Hydrophilic Wire Guides Due to Glass Contamination
Cook Inc. is recalling Roadrunner Uniglide Hydrophilic Wire Guides because they may be contaminated with glass particles. The recall covers 8,750 devices distributed worldwide.
Product
Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2357-2016·2016-08-31
Alere INRatio2 PT/INR Testing System Recalled for Inaccurate INR Results
Alere San Diego is voluntarily recalling INRatio2 PT/INR Testing Systems because some patients showed significantly higher INR results in central laboratories than on the device.
Product
Alere INRatio2 PT/INR Professional Testing System Model Number: 0200431 Product Usage: The INRatio 2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio 2 PT Monitoring system is intended for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2621-2016·2016-08-31
Cook Inc. Recalls Selective Salpingography Catheters Due to Tip Fracture Risk
Cook Inc. is recalling 7,819 Selective Salpingography Catheters with Beacon Tip due to polymer degradation that can cause the catheter tip to fracture or separate.
Product
Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Injector, Uterine Used for injection of contrast medium into the fallopian tube(s) for selective salpingography.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2661-2016·2016-08-31
Tecan INFINITE F50 Absorbance Reader Recalled for Battery Overheating Risk
Tecan US, Inc. is recalling 19 INFINITE F50 absorbance readers because the batteries may overheat, melt, or char.
Product
SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance reader for the measurement of light absorbance (optical density) of liquid media. The instrument is intended to be used primarily in in-vitro diagnostic analysis of samples from the human body to obtain…
Category
Medical Device
Distribution
19 states

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21126–21150 of 27682