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

33801–33825 of 40325

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
ModerateFDA (Devices)·Z-0765-2015·2014-12-24
Stryker Endoscopy Recalls 180,573 Cobra Grasper Instruments Due to Sterilization Labeling
Stryker Endoscopy is recalling 180,573 Cobra Grasper instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, COBRA GRASPER, 20CM, P/N 0250282007 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
ModerateFDA (Devices)·Z-0661-2015·2014-12-24
Stryker Endoscopy Recalls Schertel Forceps Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 units of Schertel Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, SCHERTEL FORCEPS, BLUNT FENESTRATED, P/N 0250080072. 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
ModerateFDA (Devices)·Z-0676-2015·2014-12-24
Stryker Debaney Forceps Recalled Due to Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 units of Debaney Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, DEBANEY FORCEPS, P/N 0250080314. 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 which allow…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0626-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, RING HANDLE, P/N 0250080236. 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 which allow them…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0610-2015·2014-12-24
Stryker Endoscopy Recalls Hasson Cannula Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 Hasson Cannula units because the instructions for use do not support specific sterilization methods.
Product
PKG, HASSON CANNULA, 11MM AUTOMATIC VALVE, STOP COCK, P/N 0250080179. 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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0718-2015·2014-12-24
Stryker Laparoscopic Manual Instruments Recalled for Sterilization Parameter Errors
Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM ROTATING HANDLE, INSULATED SHAFT/ HANDLE 45CM LENGTH, P/N 0250080595 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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0657-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Grasper Forceps Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 units of laparoscopic grasper forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, GRASPER FORCEPS, NARROW JAW, P/N 0250080287. 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
ModerateFDA (Devices)·Z-0685-2015·2014-12-24
Stryker Laparoscopic Grasper Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of laparoscopic grasper forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, GRASPER FORCEPS, DELICATE, FENESTRATED, P/N 0250080322. 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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0785-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, MARYLAND, FORCEPS CURVED, 29CM, P/N 0250282058 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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0751-2015·2014-12-24
Stryker Laparoscopic Dissector Recall Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 laparoscopic dissectors because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM X 45CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250080761 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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0617-2015·2014-12-24
Stryker Endoscopy Recalls Bullet Forceps Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of Bullet Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080041. 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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0702-2015·2014-12-24
Stryker Endoscopy Recalls Mini Metzenbaum Scissors Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of Mini Metzenbaum Scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, MINI METZENBAUM SCISSORS, CURVED, 45CM, P/N 0250080574 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…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0710-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Grasper Forceps Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of laparoscopic grasper forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, ATRAUMATIC GRASPER FORCEPS, DOUBLE ACTION 45CM, P/N 0250080585 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…
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

33801–33825 of 40325