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

4626–4650 of 5111

SevereFDA (Devices)·Z-1619-2014·2014-05-21
Fresenius Hemodialysis Machine Test Boards Recalled for Pump Detection Failure
Fresenius Medical Care is recalling Revision K Actuator Test Boards for 2008-Series Hemodialysis Machines because they may fail to detect a disconnected Ultrafiltration Pump.
Product
Revision K Actuator Test Boards sold as replacement parts for use with Fresenius 2008-Series Hemodialysis Machines (2008K, 2008K2, 2008K@home and 2008T). Part Number: 190713 Revision K
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1543-2014·2014-05-14
Med-Mizer RetractaBed Recall Due to Insufficient Welding on Foot Cross Tube
Med-Mizer is recalling 2,980 RetractaBed Clinical Contour adjustable beds due to insufficient welding on the foot cross tube, which may cause bed collapse.
Product
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 801, 802, 803, 803A: 80 " bed with 1, 2, or 3, motors and autocontour 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1565-2014·2014-05-14
SpineFrontier S-Lift Lock Shaft Inserter Recalled for Potential Breakage
SpineFrontier is recalling S-Lift Lock Shaft Inserters because the impact cap or pin may break during spinal surgery, potentially releasing fragments into the sterile field.
Product
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter as
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1570-2014·2014-05-14
Medtronic SynchroMed II Implantable Pumps Recalled for Overinfusion Risk
Medtronic is recalling SynchroMed II implantable drug infusion pumps because they may overinfuse medication, potentially causing life-threatening overdose or drug withdrawal.
Product
Medtronic SynchroMed¿ II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1546-2014·2014-05-14
Alere INRatio2 Test Strips Recalled for Inaccurate INR Results
Alere San Diego, Inc. is recalling INRatio2 PT/INR Professional Test Strips because they may report inaccurately low INR results, potentially affecting warfarin therapy monitoring.
Product
Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the Monitor and test strip, is used for quantitative determination of international normalized ratio (INR) in fresh, capillary whol
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1559-2014·2014-05-14
Teleflex Medical Recalls Bard Fixt Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling Bard Fixt Sutures because the needle may detach from the suture during use, failing to meet minimum strength requirements.
Product
Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. Indicated for use in soft tissue approximation.
Category
Medical Device
Distribution
28 states
SevereFDA (Devices)·Z-1541-2014·2014-05-14
Med-Mizer Retractabed Recall for Insufficient Welding on Foot Cross Tube
Med-Mizer is recalling 191 Retractabed Clinical Contour adjustable beds manufactured before June 7, 2008, due to insufficient welding that could cause bed collapse.
Product
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 " bed w/ 2 motors); 763 (3 motors); 763 A ( 3 motors, autocontour) 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1542-2014·2014-05-14
Med-Mizer RetractaBed Recall for Insufficient Welding on Foot Cross Tube
Med-Mizer is recalling RetractaBed Clinical Contour adjustable beds due to insufficient welding on the foot cross tube, which may cause bed collapse or rollers to detach.
Product
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1561-2014·2014-05-14
Teleflex Medical Recalls Silk Sutures Due to Needle Detachment Risk
Teleflex Medical is recalling specific lots of Deknatel Silk Sutures because the needle may detach from the suture during use.
Product
Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approximation.
Category
Medical Device
Distribution
28 states
SevereFDA (Devices)·Z-1513-2014·2014-05-07
Brainlab ExacTrac 6.0 Radiation Positioning System Recalled for Targeting Error
Brainlab AG is recalling ExacTrac 6.0 systems because they may position patients to unintended radiation targets, potentially delivering dose to the wrong location.
Product
ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue numbers: 20833B EXACTRAC 6.0 IR POSITIONING SOFTWARE 49936 ET SOFTWARE UPDATE 6.0.X TO 6.0.3 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC 49927B ET UPGRA
Category
Medical Device
Distribution
7 states
CriticalFDA (Devices)·Z-1471-2014·2014-04-30
Heartware HVAD Pump Implant Kit Recalled for Driveline Connector Separation
HeartWare Inc is recalling HVAD Pump Implant Kits because the driveline connector housing may separate. This defect could affect patients using the device for heart failure.
Product
Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catalog Numbers: 1100, 1101, 1102, 1103, 1104, and 1205. For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The Hear
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1481-2014·2014-04-30
RaySearch Ray Station Software Recalled for Dose Miscalculations
RaySearch Laboratories is recalling Ray Station software versions 2.0 through 4.0 due to dose miscalculations for support structures on CT images.
Product
RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1480-2014·2014-04-30
GE Healthcare Recalls MR Scanners Due to Gradient Coil Overheating Risk
GE Healthcare is recalling 1,546 MRI scanners worldwide because gradient coil connections may loosen, causing overheating, smoke, and potential fire.
Product
GE Healthcare, Discovery MR450, Discovery MR750, Optima MR450w, Optima MR 450w GEM, Discovery MR750w, and Discovery MR750w GEM products. Magnetic Resonance Diagnostic Device.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1492-2014·2014-04-30
Ion Beam Applications Recalls Proteus 235 Proton Therapy System Software
Ion Beam Applications is recalling Proteus 235 Proton Therapy System Legacy Software due to incorrect dose rate calculations for non-zero beam line options.
Product
Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy
Category
Medical Device
Distribution
4 states
CriticalFDA (Devices)·Z-1454-2014·2014-04-23
FDA Recalls Alligator Retrieval Devices Due to Coating Delamination Risk
Micro Therapeutics Inc is recalling Alligator Retrieval Devices because the PTFE coating may delaminate and detach from the delivery wire.
Product
Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1453-2014·2014-04-23
Ev3 Neurovascular Recalls Pipeline Embolization Devices Due to Coating Defect
Ev3 Neurovascular is recalling 32 Pipeline Embolization Devices because the PTFE coating may delaminate and detach from the delivery wire.
Product
Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
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-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-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-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-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
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
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-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

How to read this listing

Filters

4626–4650 of 5111