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

29876–29900 of 40449

ModerateFDA (Devices)·Z-2010-2016·2016-06-29
Siemens Biograph TruePoint CT/PET Scanner Upgrade Recalled for Calibration Error
Siemens is recalling a Biograph TruePoint upgrade kit because using a non-Siemens phantom for calibration may result in unexpected SUV values.
Product
BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2012-2016·2016-06-29
Siemens Biograph 6 TruePoint Scanners Recalled for Calibration Error Risk
Siemens Medical Solutions is recalling 102 Biograph 6 TruePoint scanners due to a potential for unexpected SUV values when non-Siemens phantoms are used for calibration.
Product
BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2016-2016·2016-06-29
Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk
Siemens is recalling Biograph 6-4R TruePoint PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.
Product
BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2020-2016·2016-06-29
Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk
Siemens is recalling nine Biograph mCT Flow 20-3R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.
Product
BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2024-2016·2016-06-29
Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk
Siemens is recalling 12 Biograph mCT Flow 64-3R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.
Product
BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2019-2016·2016-06-29
Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk
Siemens is recalling two Biograph PET/CT scanners due to a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Product
BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2021-2016·2016-06-29
Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk
Siemens is recalling 28 Biograph mCT Flow 20-4R PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.
Product
BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2008-2016·2016-06-29
Siemens Biograph 40 TruePoint PET/CT Scanner Recall for Calibration Error
Siemens is recalling 48 Biograph 40 TruePoint PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.
Product
BIOGRAPH 40 TruePoint, Material Number 10097303 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2007-2016·2016-06-29
Siemens Biograph 40 PET/CT Scanners Recalled for Calibration Error Risk
Siemens is recalling five Biograph 40 PET/CT scanners due to a potential for unexpected Standardized Uptake Value (SUV) readings when non-Siemens phantoms are used for calibration.
Product
BIOGRAPH 40 - 3 Ring, Material Number 10097233 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2045-2016·2016-06-29
Nico Corp. Recalls Myriad Handpiece Tissue Morcellators Due to Defective Component
Nico Corp. is recalling 63 units of Myriad handpiece tissue morcellators because a defective component causes the device to fail and become non-functional.
Product
Myriad handpiece Tissue morcellator
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-2048-2016·2016-06-29
Medtronic Recalls Two EverFiex Stents Due to Outer Box Mislabeling
Medtronic is recalling two Protege EverFiex Self-expanding Peripheral Stent Systems from lot A164580 because the outer box size label may not match the device inside.
Product
EV3 EverFiex" Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide, Rx Only, PRB35-08-040-080. The Protege EverFiex" Self-expanding Peripheral Stent System is a self-expanding Nitinol stent system intended for permanent implantation. The self-expanding stent…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2025-2016·2016-06-29
Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk
Siemens is recalling 25 Biograph mCT Flow 64-4R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.
Product
BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2022-2016·2016-06-29
Siemens Biograph TruePoint PET/CT Scanners Recalled for Calibration Error
Siemens is recalling three Biograph TruePoint PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.
Product
BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2014-2016·2016-06-29
Siemens Biograph TruePoint PET/CT Scanners Recalled for Calibration Error
Siemens is recalling 16 Biograph TruePoint PET/CT scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.
Product
BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2027-2016·2016-06-29
Siemens Biograph PET/CT Scanners Recalled for Calibration Error Risk
Siemens is recalling 13 Biograph mCT Flow Edge-4R scanners because using non-Siemens phantoms for calibration may result in unexpected SUV values.
Product
BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2039-2016·2016-06-29
Leica Biosystems Recalls CytoVision Systems Due to Windows 7 Activation Issues
Leica Biosystems Richmond Inc. is recalling 283 CytoVision Image Analysis and Capture Systems because the Windows 7 operating system is improperly activated, appearing unlicensed.
Product
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies.…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1891-2016·2016-06-22
CareFusion Recalls AVEA Comprehensive Ventilators Due to Fuse Defect
CareFusion is recalling AVEA Comprehensive ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.
Product
AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1888-2016·2016-06-22
CareFusion Recalls AVEA Ventilators Due to Fuse Defect
CareFusion is recalling AVEA Comprehensive ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.
Product
AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1894-2016·2016-06-22
CareFusion Recalls AVEA Ventilators Due to Fuse Defect
CareFusion is recalling AVEA Ventilators because a defective fuse on the TCA Board may fail, causing loss of power to the User Interface Module.
Product
TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1899-2016·2016-06-22
CareFusion Recalls AVEA Ventilator Upgrade Kits Due to Fuse Defect
CareFusion is recalling AVEA GDE upgrade kits because an incorrect fuse may fail, causing loss of power to the ventilator's user interface.
Product
AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1889-2016·2016-06-22
CareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect
CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing a loss of power to the user interface module.
Product
AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1898-2016·2016-06-22
CareFusion Recalls AVEA Ventilator Upgrade Kits Due to Fuse Defect
CareFusion is recalling AVEA Ventilator upgrade kits because an incorrect fuse may fail, causing loss of power to the User Interface Module.
Product
AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1897-2016·2016-06-22
CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk
CareFusion is recalling 922 AVEA Ventilators worldwide because an incorrect fuse may fail, causing loss of power to the user interface module.
Product
Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1978-2016·2016-06-22
Navilyst Recalls Xcela Hybrid PICC Catheters Due to Hemolysis Risk
Navilyst Medical is recalling specific Xcela Hybrid PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.
Product
Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 & H965952470, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1890-2016·2016-06-22
CareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect
CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.
Product
AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Medical Device
Distribution
Distributed nationwide

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29876–29900 of 40449