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

21101–21125 of 27647

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
SevereFDA (Devices)·Z-2664-2016·2016-08-31
Tecan Infinite M1000 Microplate Reader Recalled for Battery Overheating Risk
Tecan US, Inc. is recalling the Infinite M1000 microplate reader because its batteries may overheat, melt, or char.
Product
Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional monochromator based microplate reader that provides high performance for the vast majority of todays microplate applications and research. Besides offering absorbance and fluorescence intensity measurements, the…
Category
Medical Device
Distribution
19 states
SevereFDA (Devices)·Z-2612-2016·2016-08-31
Cook Inc. Recalls Beacon Tip Catheters Due to Tip Fracture Risk
Cook Inc. is recalling Beacon Tip catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.
Product
Beacon Tip Centimeter Sizing Catheter Beacon Tip White Vessel Sizing Catheter Beacon Tip Vessel Sizing Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2618-2016·2016-08-31
Cook Inc. Recalls Liver Access and Biopsy Needle Sets Due to Tip Fracture
Cook Inc. is recalling 52,756 Liver Access and Biopsy Needle Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.
Product
Liver Access and Biopsy Needle Set Biopsy needle kit Intended for use in obtaining liver histology samples via a jugular vein approach.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2611-2016·2016-08-31
Cook Inc. Recalls Beacon Tip Royal Flush Plus High-Flow Catheters
Cook Inc. is recalling 532,395 Beacon Tip Royal Flush Plus High-Flow Catheters worldwide due to polymer degradation that can cause the catheter tip to fracture or separate.
Product
Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2662-2016·2016-08-31
Tecan Infinite 200 Absorbance Reader Recalled for Battery Overheating Risk
Tecan US, Inc. is recalling 5 units of the Tecan Infinite 200 absorbance reader because the batteries may overheat, melt, or char.
Product
Tecan Infinite 200. The SUNRISE 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
SevereFDA (Devices)·Z-2617-2016·2016-08-31
Cook Inc. Recalls Kumpe Access Catheters Due to Tip Fracture Risk
Cook Inc. is recalling 26,076 Kumpe Access Catheters because polymer degradation can cause the tip to fracture or separate, potentially leading to device fragments in the body.
Product
Kumpe Access Catheter Cathether, Ureteral, General & Plastic Surgery Used in combination with a HiWire, Bentson, or other flexible-tipped wire guide to gain difficult ureteral access beyond a redundant or tortuous ureteral segment
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2359-2016·2016-08-31
Alere INRatio 2 Home Monitor Recalled for Inaccurate INR Readings
Alere San Diego is voluntarily recalling INRatio 2 home monitors because they may display inaccurate INR results compared to central laboratory tests.
Product
Alere INRatio2 Replacement Monitor (Home) Model Number: 0200457 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 quantitative…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2615-2016·2016-08-31
Cook Inc. Recalls FluoroSet Radiographic Tubal Assessment Sets
Cook Inc. is recalling 1,881 FluoroSet Radiographic Tubal Assessment Sets due to polymer degradation that can cause catheter tip fracture or separation.
Product
FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterine cavity for radiographic evaluation of the uterine cavity and for injection of appropriate contrast media into the fallopian tubes for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2663-2016·2016-08-31
Tecan Infinite 200 PRO Microplate Reader Recalled for Battery Overheating
Tecan US, Inc. is recalling 27 Infinite 200 PRO microplate readers because the batteries may overheat, melt, or char.
Product
Infinite 200 PRO The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been…
Category
Medical Device
Distribution
19 states
SevereFDA (Devices)·Z-2361-2016·2016-08-31
Alere INRatio PT/INR Test Strips Recalled for Inaccurate INR Readings
Alere San Diego is voluntarily recalling INRatio PT/INR test strips and meters because they may display therapeutic INR values that are significantly higher in central laboratory testing.
Product
Alere INRatio PT/INR Test Strips Model Number: 0100071, 0100139 Product Usage: The INRatio/INRatio2 Test Strips perform a modified version of the one-stage Prothrombin Time test, using a recombinant human thromboplastin reagent. The clot formed in the Prothrombin Time…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2355-2016·2016-08-31
Alere INRatio PT/INR Monitoring Systems Recalled for Inaccurate INR Results
Alere San Diego is voluntarily recalling INRatio PT/INR Monitoring Systems because they may report inaccurate INR values, potentially leading to incorrect anticoagulant dosing.
Product
INRatio Prothrombin Time (PT) Monitoring System Model Number: 0100007 Product Usage: The INRatio Prothrombin Time Monitoring System uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2665-2016·2016-08-31
Tecan Infinite M1000 PRO Microplate Reader Recalled for Battery Overheating Risk
Tecan US, Inc. is recalling 11 Infinite M1000 PRO microplate readers because their batteries may overheat, melt, or char.
Product
Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is a multifunctional monochromator-based microplate reader that provides high performance for the vast majority of todays microplate applications and research. In addition to offering absorbance and fluorescence intensity…
Category
Medical Device
Distribution
19 states
SevereFDA (Devices)·Z-2596-2016·2016-08-31
Conmed Dual Dispersive Electrodes Recalled for Burn Risk
Conmed is recalling Adult ThermoGard Dual Dispersive Electrodes because they may be incompatible with some electrosurgical generators, posing a risk of undetected pad lift and potential burns.
Product
Adult ThermoGard¿ Dual Dispersive Electrodes (for patients >15 kg.), No Cable, Catalog Number 51-7410. Intended to be used for the dispersion and return to the electrosurgical generator.
Category
Medical Device
Distribution
45 states
SevereFDA (Devices)·Z-2354-2016·2016-08-31
Alere INRatio PT/INR System Recalled for Inaccurate Warfarin Monitoring Results
Alere San Diego is voluntarily recalling INRatio PT/INR Monitoring Systems because they may show lower INR values than central laboratory tests, potentially affecting warfarin dosing.
Product
Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio ¿ 2 PT/INR Monitoring System (Professional Use): The Alere INRatio ¿ 2 PT/INR Monitoring System (Professional Use), consisting of the INRatio ¿ 2 Monitor and INRatio¿ 2 PT/INR test…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2622-2016·2016-08-31
Cook Inc. Recalls Transluminal Biliary Biopsy Forceps Sets Due to Tip Fracture
Cook Inc. is recalling 2,606 Transluminal Biliary Biopsy Forceps Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.
Product
Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy, Non-Electric Intended for access to and biopsy of tissue within the biliary ductal system
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2609-2016·2016-08-31
Baxter HomeChoice Peritoneal Dialysis Systems Recalled for Software Defect
Baxter is recalling HomeChoice and HomeChoice PRO automated peritoneal dialysis systems due to a software defect that may cause serious complications in patients with ascites.
Product
1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2360-2016·2016-08-31
Alere INRatio2 PT/INR Monitoring System Recalled for Inaccurate INR Results
Alere San Diego is voluntarily recalling INRatio2 PT/INR Monitoring Systems because they may report inaccurate INR results, potentially leading to incorrect anticoagulant dosing.
Product
Alere INRatio2 PT/INR Professional Monitoring System Model Number: 55128A Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modified version of the one-stage PT test. After a drop of blood is applied to the test strip, it is drawn into the test area and mixed with…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2362-2016·2016-08-31
Alere INRatio PT/INR Test Strips Recalled for Inaccurate Results
Alere San Diego is voluntarily recalling INRatio test strips because they may report inaccurate INR results, potentially affecting warfarin therapy.
Product
Alere INRatio/ INRatio2 PT/INR Test Strips Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU, 99008G1, 99008G3, 99008G5, 99008G7 Product Usage: The Alere INRatio¿/INRatio¿2 system uses a modified version of the one-stage PT test. After a drop of blood is…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2619-2016·2016-08-31
Cook Inc. Recalls Neff DAgostino Percutaneous Access Sets Due to Tip Fracture
Cook Inc. is recalling 5,020 Neff DAgostino Percutaneous Access Sets because polymer degradation can cause the catheter tip to fracture or separate, potentially leading to device fragments in the body.
Product
Neff DAgostino Percutaneous Access 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
HighFDA (Devices)·Z-2627-2016·2016-08-31
Merge Healthcare Recalls RadSuite Software Due to Image Display Error
Merge Healthcare is recalling RadSuite software versions 5.30 and 5.35 because the viewer may skip image slices when navigating with multiple viewports.
Product
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-2647-2016·2016-08-31
Bovie Precise 360 Handpiece Recalled for Incomplete Tip Bonding
Bovie Medical Corporation is recalling 95 units of the BVX-330NR Bovie Precise 360 Handpiece due to potential incomplete bonding of the angled tip.
Product
BVX-330NR Bovie Precise 360 Handpiece 33cm, 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

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