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

27426–27450 of 27722

HighFDA (Devices)·Z-2258-2012·2012-08-29
Beckman Coulter Recalls UniCel DxI 600 Immunoassay Systems Due to Software Anomaly
Beckman Coulter is recalling UniCel DxI 600 Access Immunoassay Systems because a software anomaly may cause erroneous test results.
Product
UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2240-2012·2012-08-29
GE OEC Recalls 9800 Fluoroscopic X-Ray Systems Due to Hard Drive Defects
GE OEC is recalling 9800 fluoroscopic x-ray systems because a replacement hard drive can cause system shutdowns, data loss, or data corruption.
Product
892.1650 Image-intensified fluoroscopic x-ray system; the device is designed to provide fluoroscopic and spot film imaging of the patient during diagnostic surgical and interventional procedures. The systems include features specifically designed for use in diagnostic and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2231-2012·2012-08-29
Terumo Advanced Perfusion System 1 Serial Interface Module Recall
Terumo is recalling 34 Serial Interface Modules for the Advanced Perfusion System 1 due to reported malfunctions and smoke odor.
Product
Serial interface module RS-485 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is the interface between the TLink Data Management ystem or Sarns CCPro Data…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2245-2012·2012-08-29
Philips CT Systems Recalled for Potential Patient Support Movement
Philips is recalling 126 CT systems because a damaged foot switch cover may cause the patient support to move unexpectedly.
Product
The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ray Systems These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. Product Usage: The Brilliance 6, 10, 16, 40, 64 and CT Big…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2232-2012·2012-08-29
Terumo Interface Module Recall for Data Transfer Malfunctions
Terumo is recalling 232 interface modules for the CDl System 100/101 due to reported data transfer malfunctions and smoke odors.
Product
Interface module for CDl System 100/101 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communicates primary pump flow data to the CDl 500 Receives blood parameter data…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2226-2012·2012-08-29
Beckman Coulter DxH Slidemaker Stainer Floor Stand Recall for Sharp Edges
Beckman Coulter is recalling 41 DxH Slidemaker Stainer Floor Stands because missing vinyl caps expose sharp edges on drawer slides, posing a physical injury risk to operators.
Product
UniCel DxH Slidemaker Stainer Stainer Floor Cabinet, PN A96152. The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole blood-sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2262-2012·2012-08-29
GE OEC Injection Cable Recall for Potential Erroneous Contrast Injection
GE OEC Medical Systems is recalling OEC Injection Cables due to a potential for erroneous auto-injection of contrast dye.
Product
GEHC OEC Injection Cable for MedRad Provis V Contrast Injector. In certain fluoroscope X-ray modes, the cable provides a signal to the auto-injector to trigger a contrast injection. Part numbers include 00-902260-01 and 00-883654-01.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2252-2012·2012-08-29
AGFA Medical Image Storage Device Recall for Data Loss Risk
AGFA Corp. is recalling IMPAC and IMPAX CV DICOMStore devices because misconfiguration may cause loss of patient data.
Product
AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV DICOMStore with Cardiovascular Purge Services (CPS), Medical Image Storage Device
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2242-2012·2012-08-29
Siemens EasyLink Informatic System Recalled for Quality Control Defect
Siemens Healthcare Diagnostics is recalling 637 EasyLink Informatic Systems because they may fail to flag quality control violations, potentially affecting patient result verification.
Product
EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended tot duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2244-2012·2012-08-29
Medtronic O-arm Imaging System Recalled for High Voltage Relay Overheating
Medtronic is recalling 17 O-arm Imaging Systems because a high voltage relay fault may cause overheating and burning.
Product
Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2236-2012·2012-08-29
GE OEC InstaTrak 3500 Carts Recalled for Tipping Hazard
GE Healthcare is recalling 99 OEC InstaTrak 3500 Carts because the imaging arm may cause the cart to tip over during use.
Product
OEC InstaTrak 3500, picture archiving and communications system intended as an aid to locate anatomical structures during open percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2257-2012·2012-08-29
Beckman Coulter Recalls UniCel DxI 800 Immunoassay Systems Due to Software Anomaly
Beckman Coulter is recalling UniCel DxI 800 Access Immunoassay Systems because a software anomaly may cause erroneous test results.
Product
UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456; Dxl 800 Reconditioned: A25285. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2062-2012·2012-08-22
Stryker Neptune 1 Gold Rover Waste Management System Recalled for Injury Risk
Stryker is recalling Neptune 1 Gold Rover waste management systems due to reports of serious injury and a fatality associated with the Neptune 2 system.
Product
Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 0700-001-000, 0700-002-000(International) Instructions For Use 0700-001-700, 0700-002-707 Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2061-2012·2012-08-22
Stryker Neptune 1 Silver Rover Recalled for Tissue Injury and Fatality
Stryker is recalling Neptune 1 Silver Rover devices due to reports of serious tissue injury and a fatality, as well as a lack of FDA clearance.
Product
Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover IFU part 0700-001-700
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2063-2012·2012-08-22
Stryker Neptune Waste Management System Recall Due to Tissue Injury and Fatality
Stryker is recalling Neptune waste management system instructions due to reports of serious injury and one fatality from improper use.
Product
Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste Management System Instructions For Use. Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2064-2012·2012-08-22
Stryker Neptune Waste Management System Recalled Due to Tissue Injury and Fatality
Stryker is recalling Neptune waste management systems after reports of serious tissue injury and one fatality. The devices also lack FDA clearance.
Product
Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in the surgical environment or physician's office to collect and dispose of surgical fluid waste.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2207-2012·2012-08-22
Philips Essenta DR X-Ray System Recalled Due to Potential C-Arm Fall
Philips Healthcare Inc. is recalling seven Essenta DR X-ray systems because the C-arm may fall. The recall covers units distributed in the US and several international countries.
Product
Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070. The Essenta DR is a multifunctional stationary X-ray Intended Use From Labeling): system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are…
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-2174-2012·2012-08-22
Shiley Reusable Tracheostomy Tubes Recalled Due to Cannula Connection Issues
Nellcor Puritan Bennett Inc. is recalling Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes due to consumer complaints regarding the connections and functions of the inner and outer cannula.
Product
Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product is intended for use to bypass upper airway obstructions, provide long term ventilation, support…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2206-2012·2012-08-22
Synthes Hemostatic Bone Putty Recalled for Potential Ignition Risk
Synthes USA HQ, Inc. is recalling 8,853 packs of Hemostatic Bone Putty because the product may ignite if contacted with electrosurgical cautery systems during surgery.
Product
Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.10S. Indicated for use as a water soluble implant material and for use in the control of bleeding from bone surfaces.
Category
Medical Device
Distribution
27 states
SevereFDA (Devices)·Z-2208-2012·2012-08-22
Philips Easy Diagnost Classic x-ray system recall for switch defect
Philips Healthcare Inc. is recalling 12 Easy Diagnost Classic stationary x-ray systems because an incorrectly mounted inclination switch may fail to stop table tilting.
Product
Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.
Category
Medical Device
Distribution
6 states
SevereFDA (Devices)·Z-2185-2012·2012-08-22
CareFusion Recalls Alaris Pump Module 8100 Due to Motor Stalls
CareFusion 303, Inc. is recalling Alaris Pump Module model 8100 units due to reports of motor stalls during infusion.
Product
Alaris Pump Module model 8100. Subsequent product code: FPA The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2190-2012·2012-08-22
Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues
Edwards Lifesciences is recalling Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
Product
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2203-2012·2012-08-22
GE Healthcare Advantage Workstations Recalled for Incorrect Aorta Measurements
GE Healthcare is recalling Advantage Workstations with Advanced Vessel Analysis due to incorrect aorta measurements and potential issues with PET data loading.
Product
GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume Viewer 2 (version 6.4-6.8) provided with Advance Vessel Analysis (AVA) and Advantage Workstation 4.4 with Volume Viewer 2 (version 6.8 or before) or Volume Viewer 3 (version 7.2 -7.3)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2194-2012·2012-08-22
Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues
Edwards Lifesciences is recalling 32,145 units of Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
Product
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who require hemodynamic monitoring.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2192-2012·2012-08-22
Edwards Lifesciences Recalls Swan-Ganz Catheters Due to Guidewire Passage Issues
Edwards Lifesciences is recalling 32,145 Swan-Ganz Thermodilution VIP Catheters because a J-tip guidewire may pass through the distal lumen hub.
Product
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring.
Category
Medical Device
Distribution
Distributed nationwide

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27426–27450 of 27722