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

19176–19200 of 27647

HighFDA (Devices)·Z-3230-2017·2017-10-04
Sorin Platinium ICDs Recalled for Potential Overconsumption Risk
Sorin Group is recalling Platinium ICDs and CRT-Ds due to a possibility of overconsumption following electrostatic discharge or MRI scans.
Product
Platinium CRT DF1 1711, Model Number TDF033U, UDI/GTIN 08031527015538, Implantable cardioverter defibrillator, Biventricular or ventricular antitachycardia pacing, Dual or single chamber arrhythmia detection Product Usage: PLATINIUM VR is indicated for use in patients…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3155-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 224 sterile M/DN Intramedullary Fixation Distal Drills because raw material anomalies may increase the risk of instrument fracture during use.
Product
M/DN Intramedullary Fixation Distal Drill 3.2 mm Diameter Pilot Tip, Item Number/EDI 47225503332, Sterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3186-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 240 ECT Internal Fracture Fixation Quick-Connect Drills because raw material anomalies may cause the instruments to fracture during use.
Product
ECT Internal Fracture Fixation Quick-Connect Drill 2.7 mm Diameter 10 cm Length, Item Number/EDI 00241002700, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3143-2017·2017-09-27
Medtronic Spine Referencing Instrumentation Recalled for Potential Breakage
Medtronic Navigation is recalling Spine Referencing Instrumentation sets due to a risk that clamps may break during use, potentially leaving components in the patient's body.
Product
Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for…
Category
Medical Device
Distribution
44 states
SevereFDA (Devices)·Z-3141-2017·2017-09-27
Medtronic Spine Referencing Instrumentation Recalled for Potential Damage
Medtronic Navigation is recalling Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall units due to a risk of component breakage or damage during use.
Product
Spine Referencing Instrumentation, Double Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the…
Category
Medical Device
Distribution
44 states
SevereFDA (Devices)·Z-3139-2017·2017-09-27
Medtronic Spine Referencing Clamp Recall for Potential Breakage
Medtronic is recalling Spine Referencing Instrumentation clamps due to a risk of breakage that could leave components in the patient's body.
Product
Spine Referencing Instrumentation, Spinous Process Clamp, Tall When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the…
Category
Medical Device
Distribution
44 states
SevereFDA (Devices)·Z-3140-2017·2017-09-27
Medtronic Spine Referencing Instrumentation Recalled for Potential Damage
Medtronic is recalling Spine Referencing Instrumentation because the clamps may be damaged if opened beyond limits, potentially leaving components in the patient.
Product
Spine Referencing Instrumentation, Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the…
Category
Medical Device
Distribution
44 states
SevereFDA (Devices)·Z-3142-2017·2017-09-27
Medtronic Spine Referencing Instrumentation Recalled for Potential Breakage
Medtronic is recalling Spine Referencing Instrumentation, Double Spinous Process Clamp, Short units because they may break during use, potentially leaving components in the patient's body.
Product
Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of…
Category
Medical Device
Distribution
44 states
HighFDA (Devices)·Z-3137-2017·2017-09-27
Medtronic Solarice Balloon Catheter Recalled for Stylette Removal Difficulties
Medtronic is recalling Solarice Rapid Exchange Balloon Dilatation Catheters due to stylette removal difficulties. The recall covers 105,633 units distributed worldwide.
Product
Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3109-2017·2017-09-20
Leonhard Lang Skintact Defibrillation Electrodes Recalled for Connection Failure
Leonhard Lang is recalling Skintact defibrillation electrodes that may fail to connect with ZOLL AED PLUS devices, potentially delaying life-saving treatment.
Product
Skintact Electrode for Defibrillation, Pacing, Monitoring, Cardioversion. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only. Used with automated external…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2870-2017·2017-09-20
X-Laser High-Power Laser Projectors Recalled for Safety Standard Non-Compliance
X-Laser is recalling 830 high-power laser light show projectors because they fail to meet federal performance standards when used in auto and music modes.
Product
X-Laser Laser Light Show projector models Aurora, Caliente Aurora, PSX-400, Mobile Beat Max, Mobile Beat Max MKII, X-Beam, Hawk 500 High-power laser light show projector.
Category
Consumer Product
Distribution
0 states
HighFDA (Devices)·Z-3117-2017·2017-09-20
Zimmer Biomet Recalls ROSA Surgical Device Foot Switches
Zimmer Biomet is recalling 64 ROSA surgical device foot switches that may freeze or shut down during use.
Product
Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. ROSA Surgical Device is a computer-controlled…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3133-2017·2017-09-20
Baxter Amia Automated Peritoneal Dialysis Set Recalled for Flow Issues
Baxter Healthcare is recalling 164,700 units of Amia Automated Peritoneal Dialysis Sets due to increased customer complaints regarding flow and drain alerts.
Product
Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3127-2017·2017-09-20
Orthofix Firebird NXG Decorticating Planer Recalled for Missing Plastic Core
Orthofix is recalling six Firebird NXG Spinal Fixation System Decorticating Planers because the plastic core was found missing, which could cause scoring of the bone screw neck.
Product
Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. .A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone screw in order to provide clearance to allow for proper seating of the modular…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-3130-2017·2017-09-20
Mako Surgical Recalls Robotic Knee System Due to Software Display Error
Mako Surgical Corporation is recalling the Makoplasty Partial Knee Application software because it may fail to display all necessary constants when the screen is full.
Product
Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3085-2017·2017-09-13
Maquet CS 100i Intra-Aortic Balloon Pump Recalled for Fluid Ingress
Maquet Datascope is recalling 14,547 CS 100i Intra-Aortic Balloon Pumps because fluid ingress and false alarms could prevent therapy.
Product
CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3086-2017·2017-09-13
Maquet CS 100 Intra-Aortic Balloon Pump Recalled for Electronic Defects
Maquet Datascope is recalling 14,547 CS 100 Intra-Aortic Balloon Pumps worldwide due to a defect that could prevent therapy initiation or continuation.
Product
CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3087-2017·2017-09-13
Maquet CS 300 Intra-Aortic Balloon Pump Recalled for Fluid Ingress Risk
Maquet Datascope is recalling CS 300 Intra-Aortic Balloon Pumps because fluid ingress could damage electronic boards, potentially preventing therapy initiation or continuation.
Product
CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle by increasing coronary perfusion and reducing left ventricular work. Coronary perfusion is increased by augmenting blood pressure during the diastolic phase of the cardiac cycle. This increase in aortic…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3110-2017·2017-09-13
Elekta MOSAIQ Radiation Therapy System Recalled for Vertical Table Shift Error
Elekta is recalling the MOSAIQ Medical Charged-Particle Radiation Therapy System because a software error inverts vertical table shifts, potentially directing therapy to incorrect areas.
Product
MOSAIQ Medical Charged-Particle Radiation Therapy System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3113-2017·2017-09-13
Beckman Coulter Hematology Analyzers Recalled for Potential Blast Detection Failure
Beckman Coulter is recalling LH 750, LH 780, and LH 500 analyzers because they may fail to flag blasts in some blood samples.
Product
Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in clinical laboratories. They also provide automated Reticulocyte analysis and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3107-2017·2017-09-13
Cardinal Health Recalls Presource Kits Contaminated with Needle Particulate
Cardinal Health is recalling Presource surgical kits because they contained BD SafetyGlide needles with loose polypropylene particulate in the fluid path.
Product
Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining devices required by customers for common surgical and other medical procedures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3103-2017·2017-09-13
MicroVention Traxcess 7 Mini Guidewire Recalled for Coating Delamination
MicroVention is recalling 34 units of Traxcess 7 Mini Guidewires because the hydrophilic coating may delaminate from the device.
Product
MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-3114-2017·2017-09-13
Beckman Coulter HmX Analyzers Recalled for Potential Blast Detection Failure
Beckman Coulter is recalling HmX CP and HmX AL analyzers because they may fail to flag or detect blasts in rare blood sample situations.
Product
Coulter HmX CP and Coulter HmX AL Analyzers The purpose of the HmX Hematology Analyzer is to separate the normal patient, with all normal system-generated parameters, from the patient who needs additional studies. These studies include further measurements of cell size and cell…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3105-2017·2017-09-13
Merge Unity Software Recall for Incorrect Gail Risk Calculations
Merge Healthcare is recalling Merge Unity software versions 10.0 through 11.1.2 Patch 4 because the software fails to identify atypical hyperplasia, leading to incorrect Gail Risk calculations.
Product
Merge Unity software, formerly known as DR Systems Unity PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Merge Unity is a medical image and information management system that allows viewing, selection, processing, printing, telecommunications, and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3112-2017·2017-09-13
Qualigen Vitamin D Immunoassay Kit Recalled for Inaccurate Test Results
Qualigen Inc is recalling specific lots of its Vitamin D Complete Immunoassay Kit because they may produce falsely low results.
Product
Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
Category
Medical Device
Distribution
Distributed nationwide

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19176–19200 of 27647