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

4576–4600 of 5038

SevereFDA (Devices)·Z-1461-2014·2014-04-23
Philips CT Scanners Recalled for Defective Service Latch Component
Philips Medical Systems is recalling 135 CT scanners because a defective service latch component can cause the patient table top to become free-floating.
Product
Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology, Brilliance iCT, Ingenuity CT, Ingenuity Core, Ingenuity Core 128 and Ingenuity Flex scanners are Computed Tomography X-ray systems.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1460-2014·2014-04-23
Siemens AXIOM Vertix MD Trauma Systems Recalled for U-Arm Drop Risk
Siemens is recalling two AXIOM Vertix MD Trauma systems because defective steel ropes may cause the U-arm to drop unexpectedly, posing a risk of serious injury to patients.
Product
AXIOM Vertix MD Trauma systems radiographic X-ray
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-1440-2014·2014-04-16
Draeger Oxylog 3000 Plus Ventilators Recalled Due to Potentiometer Fault
Draeger Medical Systems is recalling three Oxylog 3000 plus ventilators because the control knobs may interrupt contact, causing the device to stop ventilation.
Product
Draeger Oxylog 3000 plus ventilators, emergency and transport ventilator. Part number: 5704833
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1448-2014·2014-04-16
Pega Medical Recalls Fassier-Duval Intramedullary Rods Due to Material Defect
Pega Medical Inc. is recalling five units of the Fassier-Duval IM Telescopic System because the male components were made with material of lower strength than specifications.
Product
Pega Medical Inc., Fassier-Duval IM Telescopic System, male component (solid shaft), Part number: M040-SS-110; Used in Implant Catalogue number: FD-040(LS)-SS. orthopedic intramedullary rod.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1308-2014·2014-04-09
RaySearch Ray Station 4.0 software recalled for dose calculation errors
RaySearch Laboratories is recalling Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
Product
RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
Category
Medical Device
Distribution
7 states
SevereFDA (Devices)·Z-1311-2014·2014-04-09
Zoll Medical Defibrillators Recalled for Continuous Device Reset Loop
Zoll Medical is recalling 3,169 defibrillator/pacemaker/monitor units because they may latch in a continuous reset loop, rendering them unusable.
Product
Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1320-2014·2014-04-09
Merit Medical Systems Recalls Non-Sterile Custom Syringe Kits
Merit Medical Systems is recalling 15 syringe kits labeled as sterile but not sterilized. The products were distributed in the US, Thailand, and Hong Kong.
Product
Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1228-2014·2014-04-02
Thoratec HeartMate II System Controller Recalled Due to Injury and Death Reports
Thoratec is recalling HeartMate II System Controllers because serious injuries and deaths occurred when patients switched from primary to backup controllers.
Product
HeartMate II System Controller 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. It is sometimes called a a heart pump or VAD. HeartMate II is a small implantable LVAD.
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
CriticalFDA (Devices)·Z-229-2014·2014-04-02
Thoratec HeartMate II LVAD Pump Recall Due to Controller Switching Injuries
Thoratec is recalling 36 HeartMate II LVAD Pump and Pocket Controller Kits because switching from the primary to the backup controller caused serious injuries and deaths.
Product
HeartMate II LVAD Pump and Pock Controller Kit; 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-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
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
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
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-1201-2014·2014-03-19
Mar Cor Purification Reverse Osmosis Systems Recalled for Fire Risk
Mar Cor Purification is recalling 130 CWP Reverse Osmosis Systems (Models 101, 102, 104, and 106) due to a potential fire hazard from resistive heating in the pump head assembly.
Product
Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106.
Category
Consumer Product
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-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
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-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-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
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-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-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

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