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

17001–17025 of 27500

HighFDA (Devices)·Z-2768-2018·2018-09-26
Degania Foley Temperature Sensor Catheters Recalled for Defective Sensors
Degania Silicone is recalling 250 Foley Temperature Sensor Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Foley Temperature Sensor Catheter 8FR, Catalogue Number 102201100880JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3211-2018·2018-09-26
Accuray Recalls CyberKnife Calibration Film Due to Dimensional Inaccuracy
Accuray is recalling 259 units of Ashland Box Film Ball Cube II calibration film because manufacturing defects may cause up to 0.5 mm of positional inaccuracy in CyberKnife systems.
Product
Ashland(TM) Box Film Ball Cube II EBT3, P/N: 027863-002 rev E Product is used to calibrate CyberKnife systems
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3011-2018·2018-09-26
Ventana Recalls CINtec Histology Reagents Due to Dispenser Defects
Ventana Medical Systems is recalling 120 units of CINtec Histology reagents worldwide because leaking dispensers may cause false negative test results.
Product
CINtec Histology (250), Catalog Number 06680011001, model 725-4793 Immunohistochemistry (IHC) for in vitro diagnostic use.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2762-2018·2018-09-26
Degania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 1,025 Temperature Sensor Catheters because defective sensors may display lower body temperatures than actual patient readings.
Product
Temperature Sensor Catheter 18FR, Catalogue Number 102201101863BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3192-2018·2018-09-26
Invivo Xper Flex Cardio Physiomonitoring System Recalled for Firmware Error
Invivo Corporation is recalling 38 Xper Flex Cardio Physiomonitoring Systems distributed in the Netherlands due to incorrect firmware that may cause inaccurate ECG and heart rate displays.
Product
Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2781-2018·2018-09-26
Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors
Degania Silicone, Ltd. is recalling 4,372 temperature sensing Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Temperature sensing catheter 14FR, Catalogue Number 102203101463DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3015-2018·2018-09-26
Ventana NEXES VEN IVIEW DAB Detection Kit Recall for Leaking Dispensers
Ventana Medical Systems is recalling NEXES VEN IVIEW DAB Detection Kits due to leaking and sticking reagent dispensers that may cause false negative IHC results.
Product
NEXES VEN IVIEW DAB DET KT JPN-US EXPORT, Catalog Number 05266084001 Model 760-041 Immunohistochemistry (IHC) for in vitro diagnostic use.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3186-2018·2018-09-26
Polymedco PATHFAST NTproBNP Cartridges Recalled for Measurement Bias
Polymedco is recalling 272 PATHFAST NTproBNP cartridges due to a manufacturing defect that may cause measurement values to be 12% to 20% higher than actual.
Product
PATHFAST NTproBNP Catalog Number: PF1061-KUS PATHFAST¿ NTproBNP is a product for in-vitro diagnostic use with the in vitro diagnostic system PATHFAST¿ for the quantitative measurement of N-terminal-pro B-type Natriuretic Peptide (NT-proBNP) in heparinized or EDTA whole…
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-3209-2018·2018-09-26
Exactech Recalls Optetrak Logic CC Stem Extension Due to Thread Defects
Exactech is recalling one unit of the Optetrak Logic CC Stem Extension because it may have non-conforming internal threads.
Product
Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2991-2018·2018-09-26
Mobius AIRO Mobile CT System Recalled for Software Fault
Mobius Imaging is recalling 147 AIRO Mobile CT Systems because a software fault prevents the tube current modulation feature from working.
Product
AIRO Mobile CT System Model # MobiCT-32
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2755-2018·2018-09-26
Degania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 11,488 temperature sensor Foley catheters because defective sensors may display lower body temperatures than actual.
Product
Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2776-2018·2018-09-26
Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors
Degania Silicone, Ltd. is recalling 100 units of temperature sensing Foley catheters because defective sensors may display lower body temperatures than actual.
Product
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101080MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3191-2018·2018-09-26
Swissray Medical Recalls ddR Formula B X-ray Systems for Bucky Movement Risk
Swissray Medical is recalling 27 ddR Formula B X-ray systems because the bucky component may move unexpectedly, posing a risk of injury to patients.
Product
ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2780-2018·2018-09-26
Degania Silicone Recalls Thermistor Foley Catheters Due to Defective Sensors
Degania Silicone is recalling Thermistor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Thermistor Foley catheter, nonsterile, Catalogue Number 102201101463MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3010-2018·2018-09-26
Ventana anti-Helicobacter Pylori Reagent Recall Due to Dispenser Leaks
Ventana Medical Systems is recalling anti-Helicobacter Pylori reagents because leaking dispensers may cause false negative test results.
Product
VENTANA anti-Helicobacter Pylori (SP48) PAB 250, Catalog Number 06425623001, model 790-1015 Immunohistochemistry (IHC) for in vitro diagnostic use.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2775-2018·2018-09-26
Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 500 sterile Foley catheters with defective temperature sensors that may display inaccurate readings.
Product
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2784-2018·2018-09-26
Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors
Degania Silicone, Ltd. is recalling 1,000 temperature sensing Foley catheters because defective sensors may display lower body temperatures than actual.
Product
Temperature sensing catheter 14FR, Catalogue Number 102201101463NU Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2773-2018·2018-09-26
Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 500 temperature-sensing Foley catheters because defective sensors may display lower body temperatures than actual.
Product
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101480MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3175-2018·2018-09-26
Leica M525 F20 Surgical Microscope System Recalled for Tipping Hazard
Leica Microsystems is recalling 160 surgical microscopes because the instrument may tip over when the swing arm is fully extended.
Product
Leica M525 F20 Surgical Microscope System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-3000-2018·2018-09-26
Ventana OptiView Amplification Kit Recalled for Leaking Dispensers
Ventana Medical Systems is recalling OptiView Amplification Kits due to leaking dispensers that may cause false negative IHC results.
Product
OptiView Amplification Kit (250 test), Catalog Number 06718663001, model 860-099 Immunohistochemistry (IHC) for in vitro diagnostic use.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2757-2018·2018-09-26
Degania Silicone Recalls Temperature Sensor Catheters Due to Defective Sensors
Degania Silicone, Ltd. is recalling 1,588 Temperature Sensor Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2777-2018·2018-09-26
Degania Silicone Recalls Thermistor Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 2,784 Thermistor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Thermistor Foley catheter, nonsterile, Catalogue Number 102201101863MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2764-2018·2018-09-26
Degania Foley Catheters Recalled for Defective Temperature Sensors
Degania Silicone is recalling 47,520 Foley catheters with temperature sensors because defective sensors may display lower body temperatures than actual.
Product
Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2760-2018·2018-09-26
Degania Temperature Sensor Catheters Recalled for Defective Sensors
Degania Silicone is recalling 16,350 temperature sensor catheters because defective sensors may display lower body temperatures than actual.
Product
Temperature Sensor Catheter 14FR, Catalogue Number 102201101463BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3183-2018·2018-09-26
Med-Mizer Recalls PR1000 Pivot Rehab Beds Due to Cable Pinching Risk
Med-Mizer is recalling 230 PR1000 Pivot Rehab Beds because wires may become pinched during extreme left pivoting, requiring patient transfer until repaired.
Product
PR1000 Pivot Rehab Bed AC powered adjustable bed.
Category
Medical Device
Distribution
28 states

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17001–17025 of 27500