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

25626–25650 of 40357

HighFDA (Devices)·Z-0032-2018·2017-10-25
St. Jude Medical Recalls Merlin PCS 3650 Programmer for Firmware Update
St. Jude Medical is recalling 10,453 Merlin PCS 3650 programmers worldwide to install new firmware that mitigates the risk of unauthorized access to pacemakers.
Product
Merlin PCS 3650 Programmer with Model 3330 Software Version 23.1.1 The Merlin Patient Care System (PCS) Model 3650 Programmer is a portable, dedicated programming system designed to interrogate program display data and test St. Jude Medical implantable devices.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0038-2018·2017-10-25
St Jude Medical Recalls Pacemakers for Firmware Security Update
St Jude Medical is recalling 2,726 implantable pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.
Product
PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0037-2018·2017-10-25
St Jude Medical Recalls PM 1260 Assurity+ Pacemakers for Firmware Update
St Jude Medical is recalling 6,051 PM 1260 Assurity+ pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.
Product
PM 1260 ASSURITY + These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0034-2018·2017-10-25
St Jude Medical Recalls Nuance Pacemakers for Firmware Update
St Jude Medical is recalling 2,741 Nuance pacemakers to install new firmware that mitigates the risk of unauthorized access to the devices' radio frequency communications.
Product
PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0033-2018·2017-10-25
St. Jude Medical Recalls Merlin@Home Software for Pacemaker Security
St. Jude Medical is recalling Merlin@Home software to mitigate the risk of unauthorized access to pacemakers using radio frequency communications.
Product
Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0022-2018·2017-10-25
St. Jude Medical Recalls Proclaim Elite Implantable Pulse Generators
St. Jude Medical is recalling 28,817 Proclaim 5 and 7 Elite Implantable Pulse Generators because battery longevity estimations may be inaccurate.
Product
Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0030-2018·2017-10-25
St Jude Medical Recalls Pacemakers for Unauthorized Access Risk
St Jude Medical is recalling specific Assurity and Accent pacemaker models to mitigate the risk of unauthorized access via radio frequency communications.
Product
Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0036-2018·2017-10-25
St Jude Medical Recalls ZENEX Pacemakers for Firmware Update
St Jude Medical is recalling 4,828 ZENEX pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.
Product
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0029-2018·2017-10-25
St Jude Medical Recalls Pacemakers for Unauthorized Access Risk
St Jude Medical is recalling specific Anthem and Allure/Relieve pacemakers to mitigate the risk of unauthorized access via radio frequency communications.
Product
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0035-2018·2017-10-25
St Jude Medical Recalls 101 Implantable Pacemakers for Firmware Update
St Jude Medical is recalling 101 implantable pacemaker pulse generators to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.
Product
PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0026-2018·2017-10-25
CareFusion Recalls Alaris Pump Modules Due to Flow Rate Variations
CareFusion 303, Inc. is recalling Alaris Pump Module model 8100 units due to reports of increased or decreased medication flows.
Product
Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0025-2018·2017-10-25
Medtronic Recalls VCLAS Laser Applicators Due to Saline Leakage Testing Defect
Medtronic is recalling 423 VCLAS laser applicator systems because they were not appropriately tested for saline leakage during manufacturing.
Product
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0020-2018·2017-10-25
Philips Brilliance iCT SP CT Systems Recalled for Image Reconstruction Failure
Philips is recalling Brilliance iCT SP CT systems because a software defect prevents image reconstruction after bolus tracking scans, potentially requiring patients to be rescanned.
Product
Philips Healthcare Brilliance iCT SP X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0015-2018·2017-10-25
Philips Brilliance 64 CT Systems Recalled for Image Reconstruction Failure
Philips Electronics North America Corporation is recalling 606 Brilliance 64 CT systems in the US because a software defect prevents image reconstruction after certain scans.
Product
Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0016-2018·2017-10-25
Philips Ingenuity Core CT Systems Recalled for Image Reconstruction Failure
Philips is recalling 606 Ingenuity Core CT systems in the US because a software defect prevents image reconstruction after bolus tracking scans.
Product
Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0039-2018·2017-10-25
Teleflex Pilling Knife Handles Recalled for Blade Fit Issues
Teleflex Medical is recalling Pilling Knife Handles because the slot depth is out of specification, which may prevent blades from fitting properly.
Product
Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handles, which are intended for use with blades which are inserted into a slot in the handle.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0019-2018·2017-10-25
Philips Brilliance iCT CT Scanner Recall for Data Reconstruction Failure
Philips is recalling Brilliance iCT CT scanners because a software defect prevents image reconstruction after bolus tracking scans, potentially requiring patients to be rescanned.
Product
Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0027-2018·2017-10-25
Hologic Panther System Recalled for Incorrect Incubator Installation
Hologic is recalling one Panther System unit in Indiana because an incorrect incubator was installed, which may have led to incorrect Aptima Combo 2 assay results.
Product
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0012-2018·2017-10-25
Toshiba Medical Kalare Fluoroscopic X-Ray System Recalled for Image Display Failure
Toshiba American Medical Systems Inc is recalling 96 Kalare Fluoroscopic X-Ray Systems because images may fail to display on the system monitor or save to the hard disk.
Product
Toshiba Medical Kalare Fluoroscopic X-Ray System (DREX-KL80) Kalare is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. It is intended for use by…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0018-2018·2017-10-25
Philips Ingenuity Core128 CT Systems Recalled for Image Reconstruction Failure
Philips is recalling Ingenuity Core128 CT systems because a software defect prevents image reconstruction after bolus tracking scans, potentially requiring patient rescans.
Product
Philips Healthcare Ingenuity Core128 X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0028-2018·2017-10-25
Cepheid Recalls Xpert EV Assay Kits Due to Invalid Test Results
Cepheid is recalling Xpert EV Assay kits because customers reported a higher than expected number of invalid test results.
Product
Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polymerase chain reaction (RT-PCR) using the GeneXpert Dx System for the presumptive qualitative detection of enterovirus (EV) RNA in cerebrospinal fluid (CSF) specimens from…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0017-2018·2017-10-25
Philips Ingenuity CT Systems Recalled for Bolus Tracking Image Failure
Philips is recalling Ingenuity CT systems because a software defect prevents image generation during bolus tracking procedures, potentially requiring patient rescans.
Product
Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0003-2018·2017-10-18
St Jude Medical Recalls Fortify ICDs Due to Premature Battery Depletion
St Jude Medical is recalling approximately 90,563 Fortify and Fortify Assura implantable cardioverter defibrillators because they may exhibit premature battery depletion.
Product
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0004-2018·2017-10-18
St Jude Medical Recalls Unify Cardiac Resynchronization Therapy Defibrillators
St Jude Medical is recalling specific Unify and Quadra Assura cardiac resynchronization therapy defibrillators because they may exhibit premature battery depletion.
Product
Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0013-2018·2017-10-18
Handicare A-Series Patient Lifts Recalled for Premature Strap Wear
Handicare is recalling 8 A-Series patient lifts because the lift straps may wear prematurely at maximum load, posing a risk of patient drop.
Product
PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Category
Medical Device
Distribution
0 states

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