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

38551–38575 of 40449

SevereFDA (Devices)·Z-1190-2013·2013-05-08
Medtronic Recalls Deep Brain Stimulation Lead Kits Due to Damage Risk
Medtronic is recalling 30,000 Deep Brain Stimulation lead kits worldwide because the provided lead cap may damage the lead connector during use.
Product
Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system delivers electrical stimulation to selected targets in the brain. DBS Leads are indicated for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1185-2013·2013-05-08
Medi-Trace Pediatric Defibrillation Electrodes Recalled for Arcing Risk
FDA is recalling Medi-Trace Cadence Pediatric Defibrillation Electrodes because arcing or sparking may damage the leadwire, preventing the device from delivering appropriate energy to patients.
Product
Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1160-2013·2013-05-08
Hospira Recalls GemStar Infusion Pumps Due to Battery Data Loss
Hospira is recalling GemStar infusion pumps because low battery levels can corrupt data and cause an error that prevents the device from being used.
Product
GemStar Pump - Battery Product Usage: 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…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1171-2013·2013-05-08
Newport Medical Instruments Recalls HT70 Ventilator Power Pac Batteries
Newport Medical Instruments is voluntarily recalling HT70 and HT70 Plus ventilator Power Pac batteries because they may cause the ventilator to alarm and switch to backup power sooner than expected.
Product
Newport Medical Instruments HT70 and HT70 Plus ventilator Power Pac batteries Model number: HT70 and HT70 Plus. The HT70 and HT70 Plus ventilator systems are intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of…
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-1183-2013·2013-05-08
B. Braun Recalls Diacap Ultra Dialysis Fluid Filters Due to Moisture Loss
B. Braun Medical is recalling 1,580 Diacap Ultra Dialysis Fluid Filters because residual moisture may reduce over time, lowering membrane permeability.
Product
Diacap(R) Ultra Dialysis Fluid Filter, Catalog Number 7107367. Intended to filter bacteria and endotoxins from dialysis fluid.
Category
Medical Device
Distribution
Distributed nationwide
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
ModerateFDA (Devices)·Z-1186-2013·2013-05-08
Discus Dental Recalls SL3 Soft-Tissue Laser Due to Fiber Breakage
Discus Dental LLC is recalling 150 SL3 Soft-Tissue Lasers because the fiber optic system contains a fragile glass filament that broke near the handpiece.
Product
SL3 SOFT-TISSUE Laser (Model LR2002); Manuf: Discus Dental, LLC, 8550 Higuera Street, Culver City CA 90232. The SL3 is a soft-tissue diode laser intended to be used for dental procedures
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1212-2013·2013-05-08
GE Healthcare Recalls Optima MR430s MRI Scanners Due to Coolant Leak Risk
GE Healthcare is recalling 81 Optima MR430s MRI scanners because coolant supply lines may leak liquid onto the floor, creating a slippery surface and fall hazard.
Product
Optima MR430s MRI Scanner; 5000-0002 is indicated to use as a magnetic resonance imaging device of the leg (excluding the thigh), knee, ankle, foot, elbow, forearm, wrist, and hand.
Category
Medical Device
Distribution
20 states
ModerateFDA (Devices)·Z-1207-2013·2013-05-08
GE Healthcare Recalls MRI Systems Due to Image Flip Defect
GE Healthcare is recalling 4,338 MRI systems because axial and coronal images from certain sagittal 3D series may display a left-to-right flip.
Product
GE Healthcare, Discovery MR750, Discovery 450, Optima 450W (with and without GEM), Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant. Indicated for use as a diagnostic imaging device.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1209-2013·2013-05-08
GE Healthcare Recalls MRI Systems Due to Image Flip Issue
GE Healthcare is recalling specific MRI systems because reformatted images may display a left-to-right flip, potentially affecting diagnostic accuracy.
Product
GE Healthcare, Optima MR360/Brivo MR355 (HDsv), GE 0.35T Signa Ovation HD MR System, GE 0.2T Signa Profile HD MR System. Indicated for use as a diagnostic imaging device.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1213-2013·2013-05-08
Encore Medical Recalls 3DKnee e+ Tibial Inserts Due to Labeling Errors
Encore Medical is recalling five 3DKnee e+ Tibial Inserts because they were shipped with incorrect color-coded labels. The devices were distributed to California and Venezuela.
Product
3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1211-2013·2013-05-08
GE Healthcare Recalls MSK Extreme MR Scanners Due to Coolant Leak Risk
GE Healthcare is recalling 70 MSK Extreme MR Scanners because coolant supply lines may leak liquid onto the floor, creating a slippery surface and fall hazard.
Product
MSK EXTREME MR SCANNER, MODEL AA5000 The intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand.
Category
Medical Device
Distribution
20 states
ModerateFDA (Devices)·Z-1094-2013·2013-05-08
Trophy CareStream Dental X-ray System Recalled for Bent Connector Defect
Trophy Sas is recalling CareStream Dental Kodak 2100 Intraoral X-ray systems due to a bent connector defect that indicates poor contact of the HT transformer power pin.
Product
CareStream Dental Kodak 2100 Intraoral 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
ModerateFDA (Devices)·Z-1214-2013·2013-05-08
NxStage PureFlow-B Solution Recalled for Potential Mislabeled Product
NxStage Medical is recalling 1,480 cases of PureFlow-B Solution due to potential mislabeling. The product is used for hemodialysis.
Product
NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1095-2013·2013-05-08
Trophy CareStream Dental Kodak 2200 Intraoral X-ray System Recall
Trophy Sas is recalling CareStream Dental Kodak 2200 Intraoral X-ray systems due to a bent connector defect that indicates poor contact of the HT transformer power pin.
Product
CareStream Dental Kodak 2200 Intraoral 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
ModerateFDA (Devices)·Z-1208-2013·2013-05-08
GE Healthcare Recalls 1.5T SIGNA HDe MR Systems for Image Flip Issue
GE Healthcare is recalling 822 GE 1.5T SIGNA HDe MR systems worldwide due to a software issue that may cause left-to-right image flips in specific reformatted views.
Product
GE Healthcare, GE 1.5T SIGNA HDe MR SYSTEM. Indicated for use as a diagnostic imaging device.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1187-2013·2013-05-08
Masimo Recalls Rad-8 Pulse Oximeters Due to Unintended Power-Off Defect
Masimo is recalling 42,908 Rad-8 pulse oximeters worldwide because a small percentage of devices may power off unexpectedly when the patient cable is moved.
Product
Rad-8 Pulse Oximeters The Rad-8 family of pulse oximeters and accessories are indicated for the continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1180-2013·2013-05-08
Advanced Sterilization Products Recalls STERRAD CYCLESURE 24 Biological Indicators
Advanced Sterilization Products is recalling STERRAD CYCLESURE 24 Biological Indicators because the company lacks adequate data to support the entire labeled shelf-life.
Product
STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0999-2013·2013-05-08
Trophy CareStream Dental CS 2100 X-ray System Recalled for Defective Connector
Trophy Sas is recalling CareStream Dental CS 2100 X-ray systems due to a bent connector causing poor contact in the high-tension transformer power pin.
Product
CareStream Dental CS 2100 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

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38551–38575 of 40449