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

15376–15400 of 40112

SevereFDA (Devices)·Z-0876-2021·2021-01-27
Steris Reliance Vision Washer/Disinfector Recalled for Fire Risk
Steris is recalling Reliance Vision Single-Chamber Washer/Disinfector units because a faulty electrical contactor may cause the drying chamber to overheat, potentially leading to smoke or fire.
Product
Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended for use in the cleaning and intermediate level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid surgical instruments…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0868-2021·2021-01-27
Laerdal Compact Suction Unit Recalled for Potential Suction Loss
Laerdal Medical is recalling 5,035 Compact Suction Units (LCSU 4) because component failures may cause the device to lose suction, potentially delaying treatment or causing suffocation.
Product
Laerdal Compact Suction Unit (LCSU 4), Catalog Numbers 880051, 880061, 881151, 880052, 880062, 881152 - Product Usage: It is intended for intermittent operation to remove secretions, blood or vomit from a patient s airway to allow ventilation.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0871-2021·2021-01-27
Medtronic Recalls Neonatal Delta Valve Shunt Assemblies Due to Catheter Defect
Medtronic is recalling 95 Neonatal Delta Valve Shunt Assemblies because a manufacturing defect may cause the ventricular catheter to disconnect from the valve, leading to shunt malfunction.
Product
REF 27219-1 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0873-2021·2021-01-27
Medtronic Recalls Neonatal Delta Valve Shunt Assemblies Due to Catheter Defect
Medtronic is recalling specific Neonatal Delta Valve Shunt Assemblies because a manufacturing defect may cause the ventricular catheter to disconnect, leading to shunt malfunction.
Product
REF 27219-5 X1, Medtronic, Delta Valve, Neonatal, Performance Level 1.5, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0872-2021·2021-01-27
Medtronic Recalls Neonatal Delta Valve Shunt Assemblies Due to Catheter Defect
Medtronic is recalling Neonatal Delta Valve Shunt Assemblies because a manufacturing defect may cause the ventricular catheter to disconnect from the valve, leading to shunt malfunction.
Product
REF 27219-2 X1, Medtronic, Delta Valve, Neonatal, Performance Level 2.0, CE 0344, Sterile EO - Product Usage: Neonatal Delta Snap Shunt Assemblies are components of CSF-Flow Control Shunt Systems designed to provide controlled CSF flow from the ventricles of the brain into the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0882-2021·2021-01-27
Biomet Recalls A.L.P.S. Clavicle Plating System Due to Drill Fracture Risk
Biomet is recalling 174 A.L.P.S. Clavicle Plating Systems because instruments may cold weld, preventing disassociation and increasing the chance of drill fracture.
Product
A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0878-2021·2021-01-27
Fujifilm Recalls Synapse PACS Software Due to Patient Data Display Errors
Fujifilm is recalling Synapse PACS Software versions 5.1 and higher because it may display incorrect patient information or PET/CT values.
Product
Synapse PACS Software Versions 5.1 and higher
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0881-2021·2021-01-27
Abbott i-STAT EG7+ Cartridges Recalled for Ionized Calcium Test Inaccuracy
Abbott Point Of Care Inc. is recalling i-STAT EG7+ cartridges because the ionized calcium test may report higher than expected results if stored at room temperature for specific periods.
Product
Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative measurement of sodium, potassium, ionized calcium, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood. List Number: 03P76-25
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0870-2021·2021-01-27
Boston Scientific Recalls Five ACUITY Universal Cutters Due to Sterilization Failure
Boston Scientific is retrieving five ACUITY Universal Cutters that did not undergo the required sterile processing procedure.
Product
ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0883-2021·2021-01-27
Roche Cobas Infinity Software Error May Allow Unreliable Lab Results
Roche is recalling 76 licenses of Cobas Infinity software due to an error that may remove quality flags, allowing unreliable test results to be reported.
Product
A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0866-2021·2021-01-27
Skeletal Kinetics Recalls OsteoVation Bone Filler Kits Due to Labeling Discrepancy
Skeletal Kinetics is recalling 2 units of OsteoVation Inject Bone Filler Kits because of a discrepancy between the Mixing Instruction Card and the Instructions for Use.
Product
OsteoVation, Inject Bone Filler Kits, 5cc (part number 390-2005, manufacturing lot number 1129957) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0869-2021·2021-01-27
Magstim Recalls Neurosign 100 Intraoperative Nerve Monitors for Voltage Configuration Error
The Magstim Company Limited is recalling seven Neurosign 100 Intraoperative Nerve Monitors because they were configured for 240V power instead of the required 120V for the US.
Product
Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cranial motor nerves, especially the facial nerve (VII), during ENT surgical procedures.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0877-2021·2021-01-27
Roche uPath software 1.1 recalled for incorrect measurement calculations
Roche Molecular Systems is recalling uPath software 1.1 because measurement values are incorrectly calculated in Split View mode when slides have different magnifications.
Product
uPath software 1.1 and uPath software 1.1 IVD-INSW, Material numbers 08991871001 and 09077332001
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0884-2021·2021-01-27
Exactech Equinoxe Humeral Stem Recalled for Incorrect Instructions
Exactech is recalling 14 Equinoxe Humeral Stem devices because packages may include incorrect Instructions For Use (IFU).
Product
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0875-2021·2021-01-27
Beckman Coulter Recalls SARS-CoV-2 IgG Quality Control Cards
Beckman Coulter is recalling 276 units of ACCESS SARS-CoV-2 IgG Quality Control cards due to a label error regarding standard deviation values.
Product
ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0867-2021·2021-01-27
Skeletal Kinetics Recalls OsteoVation Bone Filler Kits Due to Labeling Discrepancy
Skeletal Kinetics is recalling 49 units of OsteoVation bone filler kits because the mixing instructions on the card do not match the Instructions for Use.
Product
OsteoVation, Inject, Bone Filler Kits 10cc (part number 390-2010, manufacturing lot 1130303) - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0874-2021·2021-01-27
Smiths Medical Recalls Portex Acapella DH Vibratory PEP Devices
Smiths Medical ASD Inc. is recalling 4,440 Portex Acapella DH Vibratory PEP Devices because shipping boxes may contain the wrong model number.
Product
Portex Acapella DH Vibratory PEP Device - Product Usage: a single patient use device that provides Positive Expiratory Pressure (PEP) Therapy for patients who have Cystic Fibrosis, COPD, asthma, and lung diseases with secretory problems, and patients with atelectasis.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0880-2021·2021-01-27
Abbott i-STAT CG8+ Cartridges Recalled for Ionized Calcium Test Inaccuracy
Abbott is recalling i-STAT CG8+ cartridges because the ionized calcium test may report higher than expected results if stored at room temperature for specific periods.
Product
Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood List Number: 03P88-25
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0829-2021·2021-01-20
Fresenius Citrasate Liquid Acid concentrate drums recalled for low sodium levels
Fresenius Medical Care is recalling 176 drums of Citrasate Liquid Acid concentrate because sodium and/or calcium levels were below manufacturing specifications.
Product
Citrasate Liquid Acid concentrate drums, Model Number 13-3251-CA - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0736-2021·2021-01-20
Boston Scientific Recalls Lotus Edge Valve Systems Due to Release Failure Risk
Boston Scientific is recalling 386 Lotus Edge Valve Systems because a visual inspection error could prevent the delivery system from releasing during deployment.
Product
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 27mm, sterile, REF H749LVS270, GTIN 08714729940838, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
Category
Medical Device
Distribution
38 states
SevereFDA (Devices)·Z-0729-2021·2021-01-20
Boston Scientific Recalls Lotus Edge Valve Systems Due to Deployment Defect
Boston Scientific is recalling 319 Lotus Edge Valve Systems because a visual inspection failure may prevent the delivery system from releasing during deployment.
Product
Lotus Edge Valve System, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, 25mm, sterile, REF H749LVSUS250, GTIN 08714729960911, Made in Ireland, Ballybrit Business Park, Galway, Ireland.
Category
Medical Device
Distribution
38 states
SevereFDA (Devices)·Z-0852-2021·2021-01-20
Philips Emission Computed Tomography System Software Defect Recall
Philips is recalling 2,714 Emission Computed Tomography Systems due to a software defect that may cause image misdiagnosis and incorrect patient treatment.
Product
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0838-2021·2021-01-20
Fresenius Naturalyte Liquid Acid Concentrate Recalled for Conductivity Deviation
Fresenius Medical Care is recalling Naturalyte Liquid Acid concentrate bottles due to conductivity deviations and calcium concentration below manufacturing specifications.
Product
Naturalyte Liquid Acid concentrate bottles, Product Code 08-4231-0 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0656-2021·2021-01-20
Siemens Artis Medical Imaging Systems Recalled for Radiation Safety Defect
Siemens is recalling Artis zee, Artis Q, and Artis Pheno systems because the Air Kerma Rate can exceed regulatory limits when frame rates are increased during continuous release.
Product
Artis zee/ zeego & Artis Q/ Q.zen Artis Pheno
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0816-2021·2021-01-20
Fresenius NaturaLyte Liquid Acid Concentrate Recall for Low Sodium Levels
Fresenius Medical Care is recalling NaturaLyte Liquid Acid concentrate bottles because sodium and/or calcium levels were below manufacturing specifications.
Product
NaturaLyte Liquid Acid concentrate bottles, Model Number 08-2301-3 - Product Usage: used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine.
Category
Medical Device
Distribution
Distributed nationwide

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15376–15400 of 40112