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

26576–26600 of 27686

HighFDA (Devices)·Z-1210-2013·2013-05-08
Stryker AxSOS Drill Bit Recalled Due to Incorrect Scale
Stryker Orthopaedics is recalling AxSOS Calibrated Drill Bits because an incorrect scale may cause surgeons to select screws that are 10mm longer than intended.
Product
Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System is designed to treat periarticular or intraarticular fractures of the Distal Femur, Proximal Humerus, Proximal Tibia, and the Distal Tibia. Per the operative technique, " A 4.3 mm…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1000-2013·2013-05-08
Trophy CareStream Dental CS 2200 X-ray System Recall for Bent Connector
Trophy Sas is recalling CareStream Dental CS 2200 X-ray systems due to a bent connector defect that indicates poor contact of the HT transformer power pin.
Product
CareStream Dental CS 2200 X-ray system Product Usage: The expected usage (intended use) for all of these products is for dental radiographic examination and diagnosis of the teeth, jaw and oral structures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1188-2013·2013-05-08
GE Healthcare Recalls CT Scanners Due to Heat Exchanger Bolt Defect
GE Healthcare is recalling 166 CT scanners because improperly torqued heat exchanger bolts may cause parts to detach and spill oil.
Product
GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1182-2013·2013-05-08
Siemens Medical Solutions Recalls RT Therapist Software for Safety Issues
Siemens Medical Solutions is recalling RT Therapist software versions 4.2.108 to fix multiple safety-related issues on linear accelerator systems.
Product
Software correction applies to customers who use the RT Therapist RTT4.2.108 and RT Therapist Connect RTT 4.2.108 on Siemens ARTISTE, ONCOR and PRIMUS systems. ARTISTE, ONCOR and PRIMUS family of linear accelerators are used to deliver X-ray photon and electron radiation…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1181-2013·2013-05-08
Vital Images Recalls Vitrea CT Brain Perfusion Software Due to User Confusion
Vital Images is recalling Vitrea CT Brain Perfusion software versions 6.0 and above due to potential user confusion when viewing scans from wide coverage shuttle acquisition techniques.
Product
Vitrea¿ CT Brain Perfusion made available in various configurations under the names Vitrea, Vitrea fX, VitreaAdvanced and Vitrea Enterprise Suite. Noninvasive post-processing application designed to evaluate areas of brain perfusion.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1192-2013·2013-05-08
Owens & Minor Recalls MediChoice OB/GYN Applicators Due to Rayon Defect
Owens & Minor is withdrawing MediChoice OB/GYN applicators because the rayon tip may loosen or unravel during use.
Product
MediChoice¿ Rayon Tipped OB/GYN Applicator, 8 inch, Plastic Shaft, Non-Sterile, Item Numbers WOD5001 and WOD5002. Product Usage: Usage: An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1184-2013·2013-05-08
Medi-Trace Cadence Adult Defibrillation Electrodes Recalled for Thermal Damage Risk
FDA is recalling Medi-Trace Cadence Adult Defibrillation Electrodes because arcing or sparking may cause thermal damage to the leadwire, potentially preventing the device from delivering appropriate energy to patients.
Product
Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1168-2013·2013-05-01
GE Healthcare Recalls Ventri Discovery NM 530c Nuclear Imaging Systems
GE Healthcare is recalling 556 Ventri Discovery NM 530c nuclear imaging systems because a moving table mechanism can pinch patient fingers during an exam.
Product
Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures.
Category
Medical Device
Distribution
40 states
SevereFDA (Devices)·Z-1157-2013·2013-05-01
Spinal Solutions Recalls APLIF Implants Due to Inadequate Testing
Spinal Solutions is recalling 220 APLIF implants because they lack adequate testing to prove safety. The defect could cause implant breakage or movement.
Product
APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - 10degree 184010-10 Anterior Psoas Lumbar 18 x 40 x 10mm - 10degree 184012-10 Anterior Psoas Lumbar 18 x 40 x 12mm - 10degree 184014-10 Anterior Psoas Lumbar 18 x 40 x 14mm…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1156-2013·2013-05-01
Orthopedic Alliance Recalls Blue & Gold Spine System Implants
Orthopedic Alliance LLC is recalling Blue & Gold Spine System implants and instruments because the system lacks adequate testing and documentation to demonstrate it meets performance or safety standards.
Product
Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BGC3010 Screw Cap BGR0040 Straight Rod 5.5 x 40mm BGR0050 Straight Rod 5.5 x 50mm BGR0060 Straight Rod 5.5 x 60mm BGR0070 Straight Rod 5.5 x 70mm BGR0080 Straight Rod 5.5 x 80mm BGR0090 Straight Rod…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1167-2013·2013-05-01
Beckman Coulter AU5800 Clinical Chemistry Analyzer Recalled for Software Error
Beckman Coulter is recalling 490 AU5800 Clinical Chemistry Analyzers due to a software error that may cause the system to misidentify samples and report erroneous patient results.
Product
AU5800 Clinical Chemistry Analyzer The Beckman Coulter AU5800 Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This…
Category
Medical Device
Distribution
18 states
HighFDA (Devices)·Z-1154-2013·2013-05-01
Nova StatStrip Xpress Glu-Test Strips Recalled for No Result Messages
Nova Biomedical Corporation is recalling specific lots of Nova StatStrip Xpress Glu-Test Strips because they may display a 'no result' message when tested.
Product
Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 (UK Only)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1152-2013·2013-05-01
Ortho-Clinical Diagnostics Recalls VITROS Phenobarbital Slides Due to Accuracy Issues
Ortho-Clinical Diagnostics is recalling VITROS Phenobarbital Slides because they may produce inaccurate, positively biased patient results that quality controls might miss.
Product
VITROS Chemistry Products PHBR (Phenobarbital) Slides, REF 822 1384. For the quantitative measure of phenobarbital (PHBR) concentration in serum and plasma.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1164-2013·2013-05-01
GE Healthcare Recalls Xeleris 2 Workstation Due to Software Artifact Risk
GE Healthcare is recalling 11 Xeleris 2 Processing & Review Workstations due to a software issue that may cause image artifacts in MPI studies, potentially leading to misdiagnosis.
Product
GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Emission Tomography cameras used in diagnostic radiology, including procedures for planar imaging, whole body imaging, tomographic (SPECT)…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1165-2013·2013-05-01
Philips NeuViz 16 CT Scanner Recalled Due to Pinch Hazard
Philips and Neusoft are recalling 23 NeuViz 16 CT scanners because a user error could cause personnel injuries, including a reported finger pinch.
Product
NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1166-2013·2013-05-01
Philips NeuViz Dual CT Scanner Recalled for Pinch Hazard
Philips and Neusoft are recalling 25 NeuViz Dual CT scanners because user error can cause personnel injuries, including a reported finger pinch.
Product
NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System is intended to produce cross-section images of head and body by computer reconstruction of X-ray transmission data…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1155-2013·2013-05-01
Accuray RoboCouch Patient Positioning System Recalled for Defective Gearboxes
Accuray Incorporated is recalling 16 RoboCouch Patient Positioning Systems because A5 gearboxes responsible for pitch and roll motions may be defective.
Product
RoboCouch Patient Positioning System Product Usage: is intended for use in the support and positioning of a patient during radiosurgery and radiotherapy procedures and other medical procedures when precise positioning is required.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1153-2013·2013-05-01
Nova StatStrip Xpress Glu-Test Strips Recalled for No Result Messages
Nova Biomedical is recalling specific lots of Nova StatStrip Xpress Glu-Test Strips because they may display a 'no result' message when tested.
Product
Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1116-2013·2013-04-24
Hospira GemStar Infusion Pump Recall for Potential Over-Infusion Risk
Hospira is recalling GemStar infusion pumps because the motor may rotate backwards during low-rate infusions, potentially causing over-infusion of medication.
Product
The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, rechargeable battery pack, docking station, or two…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1052-2013·2013-04-24
Stryker Recalls ShapeMatch Cutting Guides Due to Internal Process Issues
Stryker Orthopaedics is recalling ShapeMatch Cutting Guides used in knee surgeries due to potential issues with internal planning and production processes.
Product
ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1150-2013·2013-04-24
Advanced Sterilization Products Recalls EVOTECH Endoscope Cleaner Due to Smoke Risk
Advanced Sterilization Products is recalling 761 EVOTECH Endoscope Cleaner and Reprocessor systems because a circuit board malfunction can cause smoke to emanate from the device.
Product
EVOTECH Endoscope Cleaner and Reprocessor System, P/N 50004. Designed to automatically clean and high-level disinfect flexible, submersible video or fiber-optic endoscopes.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1098-2013·2013-04-24
Carefusion Recalls Alaris PC Units Due to Communication Errors
Carefusion is recalling Alaris PC unit model 8015 with software version 9.12 due to communication errors when specific monitoring modules are attached.
Product
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1126-2013·2013-04-24
Accuray CyberKnife Iris Variable Aperture Collimator Recall for Beam Axis Shift
Accuray Incorporated is recalling 176 Iris Variable Aperture Collimators for the CyberKnife System due to a defect that could shift the radiation beam's central axis.
Product
Accuray CyberKnife System Medical Physicist, Robotic Radiosurgery System, Medical charged-particle radiation therapy system, Model: Iris Variable Aperture Collimator P/Ns 028986 and 031777. The CyberKnife System is indicated for radiation treatment.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1128-2013·2013-04-24
SR Instruments FG3105 Patient Scales Recalled Due to Load Cell Failures
SR Instruments is recalling 806 FG3105 patient scales used with Joerns Healthcare lifters after two load cell failures caused patient falls.
Product
SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare Patient Lifters. Model# FG3105 Patient Scales. Product Usage: The FG3105 Scale is designed for Joerns Healthcare for use in portable patient weighing systems. The scale is designed to be connected…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1074-2013·2013-04-24
Lifescan Recalls OneTouch Verio IQ Blood Glucose Meters for Display Error
Lifescan is recalling OneTouch Verio IQ Blood Glucose Meters because they shut off instead of displaying 'EXTREME HIGH GLUCOSE' at high readings.
Product
All OneTouch Verio IQ Blood Glucose Meters sold as: Verio IQ System Kits - Meter; Verio IQ Starter kits - Meter; Verio IQ Warranty Meter. Product Usage: The OneTouch¿ VerioIQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of…
Category
Medical Device
Distribution
Distributed nationwide

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