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 deaths or serious injuries are reported, 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

4651–4675 of 5111

CriticalFDA (Devices)·Z-1230-2014·2014-04-02
Thoratec HeartMate II Pocket Controllers Recalled Due to Reported Deaths
Thoratec is recalling HeartMate II Pocket Controllers because serious injuries and deaths were reported when patients switched from primary to backup controllers.
Product
Heart Mate II Pocket Controllers removed from packaging Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1227-2014·2014-04-02
Thoratec HeartMate II Implant Kit Recalled Due to Controller Switching Injuries
Thoratec is recalling HeartMate II Implant Kits because serious injuries and deaths occurred when patients switched from primary to backup System controllers.
Product
HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1301-2014·2014-04-02
BioCardia Morph AccessPro Steerable Introducer Recalled for Particulate Risk
BioCardia is recalling Morph AccessPro Steerable Introducers due to potential particulates in the inner lumen that could cause an embolic event.
Product
Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other th
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1272-2014·2014-04-02
Siemens AXIOM Artis Systems Recalled for Potential Gantry Drop Risk
Siemens is recalling 37 AXIOM Artis angiography systems because a cooling unit defect may cause a system failure and gantry drop.
Product
AXIOM Artis Systems Product usage: Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1275-2014·2014-04-02
Velocity Medical Solutions Recalls DICOM Export Format Software
Velocity Medical Solutions is recalling DICOM Export Format for Sum Dose v3.0.0 software because it may replace calculated doses in Eclipse treatment plans.
Product
DICOM Export Format for Sum Dose with Velocity v3.0.0. A stand-alone software product that provides the oncology care specialists (physicians, physicists, dosimetrists, etc.) a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1212-2014·2014-03-26
Abbott Recalls FreeStyle Flash Blood Glucose Meters Due to Inaccurate Results
Abbott Diabetes Care is recalling FreeStyle Flash Blood Glucose Monitors because they may produce inaccurate low blood glucose readings when used with specific test strips.
Product
FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions wi
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1176-2014·2014-03-19
Biosense Webster Recalls PentaRay Nav Catheters Due to Tip Separation Risk
Biosense Webster is recalling PentaRay Nav and PentaRay Nav ECO catheters because the distal tip may separate from the shaft.
Product
PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiologica
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1150-2014·2014-03-12
Shimadzu Recalls Mobile X-ray Systems Due to Metal Plate Cracking Risk
Shimadzu Medical Systems is recalling 56 mobile X-ray systems because a connecting metal plate may crack, posing a structural safety risk.
Product
Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannnot move and/or of outpatients in emergency
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0957-2014·2014-03-05
Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0956-2014·2014-03-05
Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0950-2014·2014-03-05
Teleflex Recalls ISIS HVT Tracheal Tubes Due to Kinking Risk
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during patient use, potentially compromising the airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0951-2014·2014-03-05
Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Hazard
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during use, potentially compromising the patient's airway.
Product
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1074-2014·2014-03-05
Philips BrightView Gamma Cameras Recalled for Patient Contact Risk
Philips is recalling 1,143 BrightView gamma cameras because a positioning error can cause detectors to contact patients during imaging.
Product
Single and Dual use Emission Computer Tomography gamma cameras (BrightView XCT, BrightView X & BrightView SPECT) Philips Healthcare Systems, Cleveland, OH. Gamma cameras designed for single or dual detector nuclear imaging accommodating a broad range of Emission Computed Tomog
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1090-2014·2014-03-05
Philips HeartStart MRx Monitor/Defibrillator Recalled for ESD Component Damage
Philips is recalling HeartStart MRx Monitor/Defibrillators because a processor board component may be damaged by electrostatic discharge, disrupting ECG and SpO2 functionality.
Product
HeartStart MRx Monitor/Defibrillator; Model(s), Catalogue, or Code Number: M3535A, M3536A, M3536J, M3536MC The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained i
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1091-2014·2014-03-05
Instrumentarium Dental FOCUS 3.0 Intraoral X-ray Units Recalled for Mounting Flaw
Instrumentarium Dental is recalling FOCUS 3.0 intraoral x-ray units due to incomplete welding in the wall mount hardware, which could cause the unit to drift or fall.
Product
The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to the Sigma USB terminal which is connected to a PC, which read
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1105-2014·2014-03-05
Fresenius Recalls Optiflux B200 Flux Dialyzers Due to Port Leak Risk
Fresenius Medical Care is recalling 100,008 Optiflux B200 Flux Dialyzers because the dialysate port may leak during priming.
Product
Optiflux B200 Flux Dialyzers; Product Number: 0500325E. Single Use acute or chronic hemanalysis treatment.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1102-2014·2014-03-05
Fresenius Optiflux F200NRe Dialyzers Recalled for Dialysate Port Leak
Fresenius Medical Care is recalling Optiflux F200NRe dialyzers because the dialysate port may leak during priming, posing a risk to patients.
Product
Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E. Single Use acute or chronic hemanalysis treatment.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1049-2014·2014-03-05
Medline Recalls Cath Lab Custom Packs Due to Guidewire Coating Defect
Medline Industries is recalling 120 Cath Lab Custom Packs because the guidewire coating may flake off. The kits were distributed nationwide to specific states.
Product
CATH LAB CUSTOM PACK; REF: DYNJ40926; Packaged in Mexico by: Medline Industries, Inc., Mundelein, IL 60060; 1-800-Medline; www.medline.com Surgical kit used to supply tools required to perform angiography medical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1089-2014·2014-03-05
Orthofix Azure Anterior Cervical Plate System Recall for Fracture Risk
Orthofix is recalling Azure Anterior Cervical Plate Systems because the locking mechanism may fracture during or after implantation.
Product
Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only The Azure Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and is indicated for: A. D
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1109-2014·2014-03-05
Philips HeartStart XL Defibrillators Recalled for Power Board Failure
Philips is recalling 5,234 HeartStart XL Defibrillators/Monitors because a power board failure may prevent the device from defibrillating.
Product
Philips HeartStart XL, Defibrillator/Monitor Model number M4735A Product Usage: The M4735A HeartStart XL Defibrillator/Monitor is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support,
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1077-2014·2014-03-05
DePuy PFC SIGMA Knee Implant Recall Due to Microstructure Defects
DePuy Orthopaedics is recalling PFC SIGMA knee implants with anomalous microstructure that may decrease fatigue strength and cause fracture.
Product
PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) Used during primary total knee arthroplasty to improve patient mobility.
Category
Medical Device
Distribution
4 states
SevereFDA (Devices)·Z-1069-2014·2014-03-05
Terumo Recalls VirtuoSaph Plus Endoscopic Vessel Harvesting System
Terumo is recalling 26 units of the VirtuoSaph Plus Endoscopic Vessel Harvesting System due to potential sterility compromise.
Product
VirtuoSaph¿ Plus Endoscopic Vessel Harvesting System, Part number: VSP550, Sterile***Rx Only*** Product Usage: The VirtuoSaph Plus Endoscopic Vessel Harvesting System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1059-2014·2014-02-26
Elekta Synergy XVI Radiation Therapy System Recalled for Table Position Error
Elekta is recalling Synergy XVI radiation therapy systems because a software error can cause the treatment table to move to an incorrect position during specific online registration procedures.
Product
Synergy XVI XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs - (1) You do an online VolumeView acquisition and registration. (2) You accept t
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0999-2014·2014-02-26
Medtronic Recalls Select 3D and CAP Arterial Cannulae Due to Body Splitting
Medtronic is recalling Select 3D and Select CAP Arterial Cannulae because the cannula body may split near the suture collar.
Product
Medtronic Select CAP Arterial Cannulae. Non-Vented, Carmeda Coated, model CB78722 (22 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae has clear flexible, thin wall wire-wound PVC bodies with angled, beveled tips. The proximal end of
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0995-2014·2014-02-26
Medtronic Recalls Select 3D Arterial Cannulae Due to Body Splitting
Medtronic is recalling Select 3D Arterial Cannulae because the device body may split near the suture collar.
Product
Medtronic Select 3D Arterial Cannulae. Vented, models 78618 (18 Fr.) and 78620 (20 Fr.). Non-Vented Cannulae, models 78718 (18 Fr.) and 78720 (20 Fr.). Sterilized using Ethylene Oxide. Non-pyrogenic. The Select 3D Arterial Cannulae both have clear flexible, thin wall wi
Category
Medical Device
Distribution
Distributed nationwide

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