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

29251–29275 of 40449

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
HighFDA (Devices)·Z-2646-2016·2016-08-31
Bovie Precise 360 Handpiece Recalled Due to Adhesive Bonding Defect
Bovie Medical Corporation is recalling 95 units of the BVX-330BR Bovie Precise 360 Handpiece because the adhesive bond to the angled tip may be incomplete.
Product
BVX-330BR Bovie Precise 360 Handpiece 33cm, blade 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
HighFDA (Devices)·Z-2641-2016·2016-08-31
Ziehm Vision RFD Mobile C-arm Recalled for Radiation Warning Timer Malfunction
Ziehm Imaging Inc is recalling two Ziehm Vision RFD mobile C-arms because the radiation-warning timer and 3D interval warning may fail to alert users until the unit is rebooted.
Product
Ziehm Vision RFD, Mobile C-arm for Mobile Fluoroscopic Imaging
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-2644-2016·2016-08-31
Ziehm Vision2 Mobile C-arm Recalled for Radiation Warning Timer Malfunction
Ziehm Imaging Inc is recalling two Ziehm Vision2 mobile C-arm devices because the radiation-warning timer and 3D-specific interval warning malfunction, preventing alerts until the unit is rebooted.
Product
Ziehm Vision2, Mobile C-arm for Mobile Fluoroscopic Imaging
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-2631-2016·2016-08-31
Medtronic Recalls Alpha Total Knee Replacement Components for Passivation Issues
Medtronic is recalling three units of Alpha total knee replacement femoral components because they may not have been passivated according to job traveler requirements.
Product
RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY: 1, STERILE R,
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2642-2016·2016-08-31
Ziehm Vision R Mobile C-arm Recalled for Radiation Warning Timer Malfunction
Ziehm Imaging Inc is recalling one Ziehm Vision R Mobile C-arm device because its radiation-warning timer and 3D-specific interval warning malfunction, preventing alerts until the unit is rebooted.
Product
Ziehm Vision R, Mobile C-arm for Mobile Fluoroscopic Imaging
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-2640-2016·2016-08-31
Ziehm Vision RFD Mot Mobile C-arm Recalled for Timer Malfunction
Ziehm Imaging is recalling 14 mobile C-arm devices because the radiation-warning timer and 3D interval warning may fail to alert users until the unit is rebooted.
Product
Ziehm Vision RFD Mot, Mobile C-arm for Mobile Fluoroscopic Imaging
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-2639-2016·2016-08-31
Ziehm Vision RFD 3D Mobile C-arm Recalled for Timer Malfunction
Ziehm Imaging Inc is recalling 31 mobile C-arm devices because the radiation-warning timer and 3D interval warning may fail to alert users until the unit is rebooted.
Product
Ziehm Vision RFD 3D Mobile C-arm for Mobile Fluoroscopic Imaging
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-2645-2016·2016-08-31
Medtronic Recalls DBS Pocket Adaptors Due to Conductor Wire Fracture Risk
Medtronic is recalling DBS Pocket Adaptors Models 64001 and 64002 due to potential conductor wire fractures. A safety notification was sent to healthcare professionals regarding device handling and integrity checks.
Product
DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain stimulation. The pocket adaptor is intended to be implanted with the new replacement…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2599-2016·2016-08-31
Conmed Pediatric Dual Dispersive Electrodes Recalled for Burn Risk
Conmed is recalling 4,560 pediatric dual dispersive electrodes because they may be incompatible with some generators, risking undetected pad lift and potential burns.
Product
Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC¿ generators or conventional electrosurgery units with similar contact monitoring systems…
Category
Medical Device
Distribution
45 states
HighFDA (Devices)·Z-2658-2016·2016-08-31
Philips Ingenuity Core128 CT Systems Recalled for Image Reconstruction Defect
Philips is recalling three Ingenuity Core128 CT systems because a software upgrade can cause planned anatomy to be cut off in gated helical scan images.
Product
Ingenuity Core128, Model number 728323 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2595-2016·2016-08-31
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.), 10' (3.05m) Cable, Catalog Number 51-7310. Intended to be used for the dispersion and return to the electrosurgical generator.
Category
Medical Device
Distribution
45 states
HighFDA (Devices)·Z-2602-2016·2016-08-31
Medtronic Recalls DBS Lead Kits Due to Potential Insulation Damage
Medtronic is voluntarily recalling 70 unused DBS lead kits from three lots due to potential insulation damage identified during manufacturing.
Product
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
Category
Medical Device
Distribution
10 states

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29251–29275 of 40449