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

22451–22475 of 40299

HighFDA (Devices)·Z-3180-2018·2018-09-26
bioMerieux Recalls VITEK 2 AST-P655 Cards Due to Gentamicin Error
bioMerieux is recalling VITEK 2 AST-P655 cards because six lots were manufactured with insufficient gentamicin, potentially affecting high-level resistance screening results.
Product
VITEK(R) 2 AST-P655, For susceptibility testing of Staphylococcus spp. Enterococcus spp., ad S agalactiae against specified antimicrobials, REF 421913 Product Usage: VITEK¿ 2 is an automated system consisting of instruments, software and reagent cards designed for the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2779-2018·2018-09-26
Degania Silicone Recalls Thermistor Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 330 Thermistor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Thermistor Foley catheter, nonsterile, Catalogue Number 102201100863MD 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-2756-2018·2018-09-26
Degania Silicone Recalls Temperature Sensor Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 500 units of temperature sensor Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Temperature sensor Foley catheter 10FR, Catalogue Number 102205101080AB 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-3195-2018·2018-09-26
Fresenius 2008T Hemodialysis System Recalled for Disinfectant Exposure Risk
Fresenius Medical Care is recalling 40 units of the 2008T Hemodialysis System because a power failure during cleaning could leave disinfectant in the dialysate delivered to patients.
Product
2008T HEMODIALYSIS SYSTEM W/BIBAG, Part Number 190766, Applicable only with 2008T BlueStar Premium Upgrade Kit, Part Number 191138 Product Usage: Indicated for acute and chronic dialysis therapy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3178-2018·2018-09-26
Permobil Recalls Powered Wheelchairs Due to Backrest Bar Failure Risk
Permobil is recalling 3,134 powered wheelchairs because backrest support bars may fail, potentially causing users to fall backward and sustain injuries.
Product
Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d) C500 PS, (e) C400 PS Product Usage: The devices identified are intended to provide outdoor and indoor mobility to persons limited to a seated position that can operate a powered…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2769-2018·2018-09-26
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 actual.
Product
Foley Temperature Sensor Catheter 10FR, Catalogue Number 102201101080JP 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-3206-2018·2018-09-26
Coviden Temperature Sensing Foley Catheters Recalled for Inaccurate Readings
Coviden is recalling temperature sensing Foley catheters because they may display lower body temperature readings than the patient's actual temperature.
Product
400mL, Premium, Urine Meter, 16 FR, Silicone Temperature Sensing Foley Traywith Cath-Secure Plus, Sterile, Item Code P4P16TSD
Category
Medical Device
Distribution
24 states
HighFDA (Devices)·Z-2783-2018·2018-09-26
Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 2,461 temperature sensing Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Temperature sensing catheter 18FR, Catalogue Number 102203101863DO 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-2774-2018·2018-09-26
Degania Silicone Foley Catheters Recalled for Defective Temperature Sensors
Degania Silicone is recalling 500 units of temperature-sensing Foley catheters because defective sensors may display inaccurate, lower body temperature readings.
Product
Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101880MD 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-2772-2018·2018-09-26
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 100% Silicone Foley Catheter, sterile, Catalogue Number 102201100880MD 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-3210-2018·2018-09-26
Medline Recalls Endoscopic Cleaning Brushes Due to Detachment Risk
Medline Industries is recalling single-use endoscopic cleaning brushes because they may detach during cleaning, potentially leaving parts inside the scope.
Product
Endoscopic Cleaning Brush, single use, sold in kits and labeled as the following: a. Item Number DYK1002DCB, BRUSH, CLEANING, DOUBLE ENDED, W/ HANDLE - 300 EA/CS, 50EA/BX, 6BX/CS; b. Item Number DYK1002DBDE, BRUSH, CLEANING, DBL, DIF ENDS - 500 EA/CS, 50 EA/BX, 10…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2782-2018·2018-09-26
Degania Silicone Recalls Temperature Sensing Foley Catheters Due to Defective Sensors
Degania Silicone is recalling 34,627 temperature sensing Foley catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Temperature sensing catheter 16FR, Catalogue Number 102203101663DO 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-2771-2018·2018-09-26
Degania Foley Temperature Sensor Catheters Recalled for Defective Sensors
Degania Silicone is recalling Foley Temperature Sensor Catheters because defective sensors may display lower body temperatures than the patient's actual temperature.
Product
Foley Temperature Sensor Catheter 14FR, Catalogue Number 102201101480JP 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-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-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-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

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22451–22475 of 40299