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

25776–25800 of 40357

ModerateFDA (Devices)·Z-3118-2017·2017-09-20
Beckman Coulter Recalls Sekisui Acetaminophen Reagent Due to Carryover
Beckman Coulter is recalling 320 units of Sekisui Acetaminophen reagent because carryover from ACTH reagent may cause falsely elevated Lipase results on the AU 680 analyzer.
Product
Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label are Sekisui Diagnostics (UK) Limited, United Kingdom, and Sekisui Diagnostics P.E.I. Inc., Canada. Used in laboratory testing.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3131-2017·2017-09-20
Mako Surgical Recalls Robotic Arm Interactive Orthopedic System Software
Mako Surgical Corporation is recalling the Total Hip Application software for the RIO system due to a display error that may hide essential constants.
Product
Total Hip Application (THA) 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 procedures.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3126-2017·2017-09-20
Leica Biosystems Recalls SOX-10 Antibody Due to Temperature Excursion
Leica Biosystems Richmond Inc. is recalling 37 units of SOX-10 (Polyclonal) antibody because a delay in transit may have caused the product to be stored outside of defined temperature requirements.
Product
Cell Marque, SOX-10 (Polyclonal), 7 mL, REF PA0813, IVD, This antibody is intended for in vitro diagnostic (IVD) use. SOX-10 Rabbit Polyclonal Primary Antibody is intended for laboratory use in the detection of the SOX-10 protein in formalin-fixed, paraffin-embedded tissue…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3124-2017·2017-09-20
Leica Biosystems Recalls Napsin A Antibody Due to Temperature Excursion
Leica Biosystems Richmond Inc. is recalling 33 units of Napsin A (MRQ-60 Mab.) antibody because a delay in transit may have caused the product to be stored outside of defined temperature requirements.
Product
Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Napsin A protein in formalin-fixed…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3122-2017·2017-09-20
Leica Biosystems Recalls MiTF Antibody Due to Temperature Deviation
Leica Biosystems Richmond Inc. is recalling 10 units of Microphthalmia Transcription Factor (MiTF) antibody because a transit delay caused the product to be stored outside required temperature ranges.
Product
Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF) (C5/D5) antibody is intended for qualified laboratories to qualitatively…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3116-2017·2017-09-20
Becton Dickinson Recalls SafetyGlide Needles Due to Foreign Matter
Becton Dickinson is recalling 1,249,200 units of BD SafetyGlide needles because they contain loose polypropylene foreign matter above release specifications.
Product
BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings…
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-3119-2017·2017-09-20
bioMerieux Recalls eMAG System Due to Manufacturing Anomalies
bioMerieux, Inc. is recalling 15 eMAG System units in the US and 11 countries due to anomalies identified during manufacturing controls.
Product
eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, with liquid and homogeneous properties (as part of their natural…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3125-2017·2017-09-20
Leica Biosystems Recalls PAX8 Antibody Due to Temperature Deviation
Leica Biosystems Richmond Inc. is recalling five units of PAX8 antibody because a transit delay may have caused the product to be stored outside required temperature limits.
Product
Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3129-2017·2017-09-20
Fujifilm Endoscope Corrective Action Following FDA Inspection
Fujifilm Medical Systems U.S.A., Inc. is conducting a corrective action for specific endoscope models following an FDA inspection.
Product
Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-3123-2017·2017-09-20
Leica Biosystems Recalls MSH6 Antibody Due to Temperature Deviation
Leica Biosystems Richmond Inc. is recalling 13 units of MSH6 antibody (REF PA0804) because a delay in transit may have caused the product to be stored outside of required temperature ranges.
Product
Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-3132-2017·2017-09-20
Boston Scientific Recalls FFR Link Signal Processing Modules for Missing Test Records
Boston Scientific is recalling three FFR Link Signal Processing Modules because the device history record was missing documentation for final electrical testing.
Product
FFR Link-FFR Signal Processing Module, Material Number H7495551000 It is intended to condition physiological signals from measuring devices (BSC Pressure Guidewire or an external pressure transducer), transmit and receive via radiofrequency, and recondition the signals so they…
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-3128-2017·2017-09-20
Fujifilm ED-530XT Endoscope Manuals Recalled Following FDA Inspection
Fujifilm is recalling 260 user manuals for the ED-530XT endoscope following an FDA inspection. The recall is a corrective action to address documentation issues.
Product
Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other…
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
HighFDA (Devices)·Z-3104-2017·2017-09-13
Stanmore JTS Distal Femoral Implant Recalled Due to Extension Failure
Stanmore Implants Worldwide Ltd. is recalling 15 JTS Distal Femoral Extendible Implants because they may fail to extend as intended due to incorrect orientation or settings.
Product
JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.
Category
Medical Device
Distribution
10 states
ModerateFDA (Devices)·Z-3108-2017·2017-09-13
CryoLife On-X Heart Valve Recall Due to Device Mix-Up
CryoLife is recalling five On-X Prosthetic Heart Valves because a return authorization error caused them to be redistributed and implanted in two patients.
Product
On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position in cases that involve an ascending aortic aneurysm or other associated aortic…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-3072-2017·2017-09-06
Medspira mcompass Balloon Catheters Recalled for Potential Separation
Medspira is recalling mcompass 2-channel Balloon Catheters because the balloon may separate from the inner stem and remain in the rectal cavity.
Product
mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-001) which includes a FOB component connected to the balloon catheter to inflate…
Category
Medical Device
Distribution
5 states

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