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

23976–24000 of 27699

HighFDA (Devices)·Z-0808-2015·2014-12-24
Siemens Biograph mCT Flow 40-4R Recalled for Display Freeze Risk
Siemens Medical Solutions is recalling one Biograph mCT Flow 40-4R scanner due to a potential display freeze during CT interventional procedures.
Product
Biograph mCT Flow 40-4R, System Material Number 10529159. The Siemens Biograph mCT 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
2 states
HighFDA (Devices)·Z-0451-2015·2014-12-24
GE Healthcare Recalls Innova IGS 540 Imaging Systems Due to Motion Loss
GE Healthcare is recalling 10 Innova IGS 540 systems because they may lose real-time imaging or gantry motion due to electromagnetic sensitivity.
Product
Innova IGS 540 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0754-2015·2014-12-24
Stryker Johann Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling Johann Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM X 45CM INSERT, JOHANN FORCEPS, P/N 0250080764 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0526-2015·2014-12-24
Varian On-Board Imager X-ray Generators Recalled for Missing Ground Wire
Varian Medical Systems is recalling 32 On-Board Imager systems because the X-ray generators are missing a required ground wire.
Product
Varian On-Board Imager Advanced Imaging System. The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial land¿¿ marks.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0453-2015·2014-12-24
GE Healthcare Recalls Innova 4100IQ Fluoroscopic Imaging Systems
GE Healthcare is recalling six Innova 4100IQ fluoroscopic systems due to a defect that may cause loss of real-time imaging or gantry motion.
Product
Innova 4100IQ Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and Interventional procedures and optionally, rotational imaging procedure.
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0829-2015·2014-12-24
Mako Surgical Recalls RESTORIS PST Acetabular Straight Shell Impactors
Mako Surgical Corporation is recalling 404 RESTORIS PST Acetabular Straight Shell Impactors due to the potential for intraoperative damage.
Product
RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0807-2015·2014-12-24
Siemens Biograph mCT Flow Edge-4R Recalled for Display Freeze Risk
Siemens Medical Solutions USA Inc. is recalling four Biograph mCT Flow Edge-4R scanners due to a potential system display freeze during CT interventional procedures.
Product
Biograph mCT Flow Edge-4R, System Material Number 10528955. The Siemens Biograph mCT 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
2 states
HighFDA (Devices)·Z-0825-2015·2014-12-24
DePuy Ceramic Femoral Head Recalled for Fit Issues in Hip Surgery
DePuy Orthopaedics is recalling 19 units of BIOLOX delta TS Ceramic Femoral Heads due to reports that the device did not fit as expected during hip surgery.
Product
Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0815-2015·2014-12-24
Philips QLAB Software Recall for Incorrect Ejection Fraction Calculations
Philips Ultrasound is recalling QLAB software versions 10.0, 10.1, and 10.1.1 because automated quantification features may report inaccurate cardiac measurements, potentially leading to misdiagnosis.
Product
Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xcelera software. *********************************************************************************** Devices identified in the Field…
Category
Medical Device
Distribution
32 states
HighFDA (Devices)·Z-0236-2015·2014-12-24
Philips Brilliance iCT Computed Tomography System Software Defect Recall
Philips Medical Systems is recalling 16 Brilliance iCT Computed Tomography X-Ray Systems due to a software defect that may prevent scans from terminating at the intended location.
Product
Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP is a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data taken at different…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0805-2015·2014-12-24
AMS Monarc Subfascial Hammock Kits Recalled for Packaging Integrity Concerns
American Medical Systems is recalling Monarc + and Monarc C Subfascial Hammock kits because routine testing showed the sterile packaging might fail during extreme shipping.
Product
AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195, Sterilized Using Ethylene Oxide. The Monarc + and Monarc C subfascial hammocks are sterile, single use procedure kits, each consisting…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0800-2015·2014-12-24
Carestream DRX-Revolution Mobile X-Ray System Recalled for Broken Bolts
Carestream Health is recalling 629 DRX-Revolution Mobile X-Ray Systems because bolts securing the x-ray tube assembly may break, posing a risk of equipment failure.
Product
DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 1060177 (China) and 1019397 (all other countries) --- Carestream Health, Inc. The DRX-Revolution Mobile X-Ray System is a mobile imaging system that incorporates a self contained x-ray…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0803-2015·2014-12-24
Stryker Spine Recalls Specialty Audible Torque Wrench Due to Fracture
Stryker Spine is recalling 15 units of the Specialty Audible Torque Wrench (Lot 4279) after a customer reported the device fractured during surgery.
Product
Specialty Audible Torque Wrench Mfg by: Stryker Spine, Catalog number IS3002XLP, Non-sterile. Used to final tighten to 12 Nm the blocker of the XIA 3, Hooks, Monoaxial Screws, Rod to Rod Connectors and Off-set connectors.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0508-2015·2014-12-24
Philips MobileDiagnost wDR Recalled for Unintended Radiation Exposure Risk
Philips Medical Systems is recalling MobileDiagnost wDR units due to a potential for unintended radiation exposure during start-up.
Product
Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with the patient sitting, standing or…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0801-2015·2014-12-24
Siemens Recalls Turbo Troponin I Diagnostic Kits for Potential Diagnostic Errors
Siemens Healthcare Diagnostics is recalling 3,622 Turbo Troponin I kits used to diagnose heart attacks due to a Class II safety concern.
Product
Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0830-2015·2014-12-24
Mako Surgical Recalls RESTORIS PST Acetabular Offset Shell Impactors
Mako Surgical Corporation is recalling 404 RESTORIS PST Acetabular Offset Shell Impactors because they may be damaged during surgery.
Product
RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0777-2015·2014-12-24
Stryker Laparoscopic Scissors Recalled for Sterilization Parameter Errors
Stryker Endoscopy is recalling 180,573 laparoscopic hook scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, HOOK SCISSORS, 29CM, P/N 0250282049 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0810-2015·2014-12-24
Siemens Biograph mCT Scanners Recalled for Potential Display Freeze
Siemens Medical Solutions is recalling eight Biograph mCT S(64)-4R scanners due to a risk of system display freeze during CT interventional procedures.
Product
Biograph mCT S(64)-4R, System Material Number 10248672. The Siemens Biograph mCT 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
2 states
HighFDA (Devices)·Z-0809-2015·2014-12-24
Siemens Biograph mCT X-4R Recalled for Potential Display Freeze During Procedures
Siemens Medical Solutions is recalling eight Biograph mCT X-4R scanners due to a possibility of system display freeze during CT interventional procedures.
Product
Biograph mCT X-4R, System Material Number 10248670. The Siemens Biograph mCT 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
2 states
HighFDA (Devices)·Z-0811-2015·2014-12-24
Siemens Biograph mCT S(40)-4R Recalled for Display Freeze Risk
Siemens Medical Solutions is recalling eight Biograph mCT S(40)-4R scanners due to a potential system display freeze during CT interventional procedures.
Product
Biograph mCT S(40)-4R, System Material Number 10248671. The Siemens Biograph mCT 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
2 states
HighFDA (Devices)·Z-0759-2015·2014-12-24
Stryker Laparoscopic Scissors Recalled for Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 units of 3mm Peritoneal Scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, PERITONEAL SCISSORS, 20CM, P/N 0250282001 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0452-2015·2014-12-24
GE Healthcare Recalls Discovery IGS 740 Imaging Systems Due to Loss of Function
GE Healthcare is recalling Discovery IGS 740 systems because they may lose real-time imaging or motion capabilities due to electromagnetic sensitivity.
Product
Discovery IGS 740 Indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-0821-2015·2014-12-24
Mitsubishi VERO Linear Accelerator Software Recall for Image Display Error
Mitsubishi Heavy Industries is recalling four VERO Linear Accelerator systems in the US due to a software anomaly that may display incorrect image angles for patient positioning.
Product
VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-14021, Software Version: 3.1, 3.2 and 3.5.0.
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-0180-2015·2014-12-17
Covidien Recalls Puritan Bennett 980 Ventilators Due to Capacitor Failure
Nellcor Puritan Bennett is recalling 324 Puritan Bennett 980 Ventilators because a capacitor component can fail, causing a dim screen and thermal odor.
Product
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0507-2015·2014-12-17
TomoTherapy Treatment System Recalled for Jaw Position Monitoring Failure
TomoTherapy Incorporated is recalling 210 TomoTherapy Treatment Systems worldwide due to a software defect that may fail to monitor jaw position after an error, potentially leading to incorrect treatment delivery.
Product
TomoTherapy Treatment System with software versions 2.0.1 / 2.0.2 / 2.0.3/ (Hi:Art 5.0.1 / 5.0.2 / 5.0.3)
Category
Medical Device
Distribution
Distributed nationwide

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23976–24000 of 27699