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

25551–25575 of 40233

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
HighFDA (Devices)·Z-0014-2018·2017-10-18
Handicare Recalls Carina Mobile Lifts Due to Small Locking Pin
Handicare AB is recalling nine Carina mobile lifts because they were delivered with locking pins that are too small. This defect may cause increased wear on internal components.
Product
Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0011-2018·2017-10-18
Abbott ARCHITECT c4000 Cuvette Segment Recall for Potential False Results
Abbott is recalling 1,385 ARCHITECT c4000 cuvette segments because a detached post may cause falsely depressed patient results in adjacent cuvettes.
Product
ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette segments are a component to the ARCHITECT c4000 system. Cuvette segments are racks that sit in the reaction carousel and hold cuvettes. Each…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3239-2017·2017-10-11
Firefly Medical Recalls IVEA Product Part Number 16100 Model 500A
Firefly Medical is recalling 570 IVEA units because dowel pins can rotate and dislodge from leg castings after repeated use.
Product
IVEA Product Part Number 16100 Model 500A
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0006-2018·2017-10-11
Permobil Electric Wheelchair Bases Recalled for Top Plate Assembly Failure
Permobil is recalling 146 electric wheelchair bases due to a potential failure of the top plate assembly that connects the seating system to the base.
Product
Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0005-2018·2017-10-11
Permobil Recalls Electric Wheelchairs Due to Top Plate Assembly Failure Risk
Permobil is recalling 5,539 Corpus II electric wheelchairs because the top plate assembly may fail, potentially disconnecting the seating system from the base.
Product
Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3237-2017·2017-10-11
Radiometer AutoCheck5+ Level 2 Quality Control Ampoules Recalled for Inaccurate Results
Radiometer America is recalling AutoCheck5+ Level 2 quality control ampoules because they may provide incorrect pCO2 and pO2 results.
Product
AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers The QUALICHECK+ quality control (QC) ampoules are specifically designed for Radiometer America s blood gas analyzers
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3240-2017·2017-10-11
Metrix Secure 100mL Vinyl Containers Recalled for Incorrect Material Labeling
The Metrix Company is recalling Secure 100mL empty vinyl containers because the hot stamp label incorrectly states the material. The bags are correctly made of PVC.
Product
SECURE(R) 100mL EMPTY VINYL CONTAINER With 2 Ports - (5 Boxes of 40), REF 58719, STERILE R,
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-3238-2017·2017-10-11
BOMImed Laryngoscope Handle Recalled for Intermittent Lighting
Bomimed is recalling specific lots of Disposable Fiber Optic Medium Laryngoscope Handles due to a potential for intermittent lighting during use.
Product
BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an individual peel pouch, 20 handles per box. The rigid laryngoscope handle is a device used along with a blade to examine and visualize a patient's airway and aid placement of a tracheal…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0007-2018·2017-10-11
Implant Direct Recalls Swish Duo-Grip Healing Collars Due to Wrong Component
Implant Direct is recalling 50 units of Swish Duo-Grip Healing Collars because the packages contained the wrong component size.
Product
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Category
Medical Device
Distribution
Distributed nationwide

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25551–25575 of 40233