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

24251–24275 of 40397

HighFDA (Devices)·Z-1413-2018·2018-04-25
Philips Brilliance 64 CT System Recalled for Emergency Stop Defect
Philips Medical Systems is recalling six Brilliance 64 CT systems because closing the emergency stop may disable the horizontal motor, allowing the couch to move during patient loading.
Product
Brilliance 64 - Model no. 728231, Computed Tomography X-Ray system 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. These…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1433-2018·2018-04-25
Philips Intera 1.5T MRI Systems Recalled for Helium Gas Risk
Philips is recalling Intera 1.5T MRI systems due to a potential risk of helium gas release during a magnet quench.
Product
Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera 1.5T Master CV Model 781107, 5) Intera 1.5T Explorer/ Nova Dual Model 781108, 6) Intera 1.5T IT Model 781160, 7) Intera 1.5T…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1378-2018·2018-04-25
Cook Inc. Recalls MINC Benchtop Incubators Due to Temperature Control Defect
Cook Inc. is recalling 4,451 MINC Benchtop Incubators because a heater defect may cause temperatures to become too high or too low for proper cell culture.
Product
MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a microprocessor controlled, gassed, humidified, incubator intended for use in cell culture.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1414-2018·2018-04-25
Philips IQon Spectral CT Recalled for Emergency Stop Defect
Philips is recalling 47 IQon Spectral CT systems because closing the emergency stop may disable the horizontal motor, allowing the couch to move during patient loading.
Product
IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system 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. These…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1401-2018·2018-04-25
Siemens Oncor Impression Plus Linear Accelerator Software Recall
Siemens is recalling 15 Oncor Impression Plus linear accelerators to update software and reduce the risk of collision during automated cancer treatments.
Product
ONCOR Impression Plus, Digital Linear Accelerator, Model No. 05857912 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1389-2018·2018-04-25
Stryker Power-LOAD Cot Fastening System Recalled for Broken Floor Plates
Stryker is recalling 4,724 Power-LOAD Cot Fastening Systems because the floor plates holding ambulance cot anchors may be broken.
Product
Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000, UDI: 07613327261523 Power-LOAD is intended to assist with loading and unloading of a compatible wheeled stretcher (ambulance cot) to and from a transport vehicle and to secure the ambulance cot during…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1410-2018·2018-04-25
Philips CT Scanner Recall Due to Emergency Stop Defect
Philips is recalling 106 Brilliance Big Bore CT scanners because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient loading or unloading.
Product
Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray system 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1402-2018·2018-04-25
Siemens PRIMUS HI Digital Linear Accelerator Software Recall
Siemens is recalling 18 PRIMUS HI Digital Linear Accelerators to update software and reduce the risk of collision during automated cancer treatments.
Product
PRIMUS HI, Digital Linear Accelerator, Model No. 04504200 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1431-2018·2018-04-25
Philips Intera 0.5T MRI Recalled for Helium Gas Risk
Philips is recalling 8,205 Intera 0.5T MRI scanners worldwide due to a potential risk of helium gas release during a magnet quench.
Product
Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1406-2018·2018-04-25
Philips Ingenuity Core CT Systems Recalled for Couch Movement Hazard
Philips is recalling 281 Ingenuity Core CT systems because the emergency stop may fail to lock the couch, allowing it to move during patient loading.
Product
Ingenuity Core - Model no. 728321, Computed Tomography X-Ray system 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. These devices…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1381-2018·2018-04-25
Zimmer Biomet Recalls Segmental System Proximal Femoral Components
Zimmer Biomet is recalling specific proximal femoral components due to potential machining debris that may not have been adequately removed during cleaning.
Product
Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1397-2018·2018-04-25
Siemens MEVATRON M2 Linear Accelerator Recalled for Collision Risk
Siemens is recalling 18 MEVATRON M2 linear accelerators to update software and reduce the risk of collision during automated cancer treatments.
Product
MEVATRON M2 / PRIMUS Mid-Energy, Digital Linear Accelerator, Model No. 01940035 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1442-2018·2018-04-25
Philips T5 MRI Scanner Recalled for Helium Gas Risk
Philips is recalling T5 MRI scanners due to a potential risk of helium gas release during a magnet quench.
Product
T5 Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1428-2018·2018-04-25
Halyard Closed Suction System Flex Connectors May Disconnect During Use
Halyard Health is recalling certain Closed Suction Systems because Flex Connectors may become loose or disconnect before or during use.
Product
Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿Swivel¿Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN); b. HALYARD* TRACH…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1400-2018·2018-04-25
Siemens ONCOR Impression Linear Accelerator Software Update Recall
Siemens is recalling seven ONCOR Impression Digital Linear Accelerators to update software and reduce the risk of collision during automated cancer treatments.
Product
ONCOR Impression , Digital Linear Accelerator, Model No. 05857920 Product Usage: The intended use of the device is to deliver x-ray radiation for therapeutic treatment of cancer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1435-2018·2018-04-25
Philips Achieva 1.5T MRI Systems Recalled for Helium Gas Risk
Philips is recalling 8,205 Achieva 1.5T MRI systems worldwide due to a potential risk of helium gas release during a magnet quench.
Product
Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) Achieva 1.5T R5 based Model 781343, 7) Achieva 1.5T Conversion R5 based Model…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1439-2018·2018-04-25
Philips ACS-NT MRI Scanner Recalled for Helium Gas Leak Risk
Philips is recalling 8,205 ACS-NT MRI scanners due to a potential risk of helium gas release into the examination room during a magnet quench.
Product
ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1403-2018·2018-04-25
Teleflex Medical One Way Valve Recall for Potential Disconnection
Teleflex Medical is recalling specific lots of HUDSON RCI One Way Valves because they may disconnect, causing an interruption of ventilation to patients.
Product
Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 Product Usage: for use in respiratory and anesthesia circuits to connect two or more components of a breathing system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1408-2018·2018-04-25
Philips Brilliance iCT CT Systems Recalled for Emergency Stop Defect
Philips is recalling 295 Brilliance iCT CT systems because closing the Emergency Stop may disable the horizontal motor, allowing the couch to move during patient loading.
Product
Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system 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. These…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1385-2018·2018-04-25
Datascope Mega Intra-Aortic Balloon Catheter Recalled for Missing Contraindications
Datascope is recalling Mega Intra-Aortic Balloon Catheters because the U.S. Instructions for Use were missing the Contraindications section.
Product
Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1422-2018·2018-04-25
Carefusion Recalls Jamshidi Needle Biopsy Devices Due to Packaging Integrity Concerns
Carefusion 2200 Inc is recalling 790 units of Jamshidi Needle Biopsy devices because the integrity of the sterile packaging is potentially compromised.
Product
JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP, 16G X 100MM DISP, 17G X 100MM, 16G X 70MM DISP]; STERILE;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1416-2018·2018-04-25
Terumo HX2 Temperature Management System Recall for Updated Cleaning Instructions
Terumo is recalling HX2 Temperature Management Systems to update cooler-heater cleaning instructions. The recall affects 2,393 units distributed worldwide.
Product
Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1375-2018·2018-04-25
Wright Medical VALOR Nail Recall for Missing Compression Screw
Wright Medical Technology is recalling 47 units of VALOR Nails that may be missing an assembled compression screw.
Product
WRIGHT, Wright Medical Technology, VALOR(R) Nail, Right, Medium, OD: 10mm, L: 200mm, REF415101020
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1444-2018·2018-04-25
TMJ Solutions Recalls Misidentified Right Mandibular Component
TMJ Solutions Inc is recalling a specific right mandibular component of a TMJ Reconstruction Prosthesis System because it was mislabeled and is not the correct component for the intended patient.
Product
Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of TMJ Reconstruction Prosthesis System. Model /catalog # TYY-NNNNRM The TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis System is intended to be used for the reconstruction of the…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1390-2018·2018-04-25
NAMIC Fluid Management Convenience Kits Recalled for Assembly Defect
Angiodynamics Inc. is recalling 38 NAMIC Fluid Management Convenience Kits because the Fluid Delivery Set was not assembled to specification, preventing device use.
Product
Fluid Management Convenience Kits (Angioplasty Kits) intended to be used in Fluid Management and/or Invasive Pressure Monitoring systems.
Category
Medical Device
Distribution
0 states

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