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

20426–20450 of 27647

SevereFDA (Devices)·Z-0701-2017·2016-12-14
3M Recalls Universal Electrosurgical Pads Due to Unintended Material Defect
3M is recalling Universal Electrosurgical Pads because an unintended process liner may impede the safe return of electrosurgical current, increasing the risk of patient burns.
Product
3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Universal Electrosurgical Pad with Cord, REF 9135-LP (40 pads / case) Product Usage: 3M Universal Electrosurgical Pads are designed to work with most electrosurgical unite (ESU) for virtually every…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0723-2017·2016-12-14
Siemens ADVIA 560 Hematology Systems Recalled for Incorrect Results
Siemens is recalling ADVIA 560 Hematology Systems because a database issue may cause multiple discordant records to be generated for the same sample, leading to incorrect results.
Product
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-0707-2017·2016-12-14
Merge Healthcare Recalls eFilm Workstation Software Due to Measurement Errors
Merge Healthcare is recalling eFilm Workstation software versions 2.1 through 4.1 because RF projection images may display incorrect measurements without a calibration indicator.
Product
Merge, eFilm Workstation and eFilm Lite eFilm Workstation with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules receives digital images and data from various sources (including but not limited to CT, MR, US, RF units…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0721-2017·2016-12-14
RayStation Radiation Therapy Software Recalled for Dose Calculation Errors
RaySearch Laboratories is recalling RayStation software versions 4.0, 4.5, 4.7, and 5.0 due to potential inaccuracies in proton dose calculations for specific treatment plans.
Product
RayStation 4.0, 4.5, 4.7 and 5.0; Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0680-2017·2016-12-14
Olympus Vanta Analytical X-Ray System Recalled for Unintentional Emission Risk
Olympus is recalling 41 Vanta Analytical X-Ray Systems due to a risk of unintentional x-ray emission if users attempt to terminate the sequence early.
Product
Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0693-2017·2016-12-14
Philips Brilliance 64 CT Systems Recalled for Software Error
Philips Medical Systems is recalling 184 Brilliance 64 CT systems worldwide due to a software error involving the filament on timer.
Product
Brilliance 64 728231 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and…
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-0697-2017·2016-12-14
Philips Ingenuity CT Systems Recalled for Software Timer Error
Philips Medical Systems is recalling 371 Ingenuity CT systems worldwide due to a software error involving the filament on timer.
Product
Ingenuity CT 728326 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and…
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-0703-2017·2016-12-14
DePuy Recalls LCS Knee Revision Insert Due to Manufacturing Defect
DePuy Orthopaedics is recalling one lot of LCS Complete Knee Revision System VVC Inserts because they were manufactured outside of specifications, preventing proper seating in the tibial tray.
Product
LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0706-2017·2016-12-14
Philips Spectral CT Software Recalled for Image Processing Defects
Philips Medical Systems is recalling Spectral CT software due to a defect causing issues with filming, saving, and annotating images.
Product
Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0696-2017·2016-12-14
Philips Ingenuity Core 128 MRI Software Recall for Timer Error
Philips Medical Systems is recalling 509 Ingenuity Core 128 MRI systems due to a software error involving the filament on timer.
Product
Ingenuity Core 128 728323
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-0720-2017·2016-12-14
RayStation 5.0 Radiation Therapy Software Recalled for Dose Display Error
RaySearch Laboratories is recalling RayStation 5.0 software due to a potential error in dose display on auxiliary CT images, which could result in incorrect treatment planning data.
Product
Radiation Therapy Treatment Planning System Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0367-2017·2016-12-07
Greatbatch Offset Cup Impactor Recalled for Sterility Testing Failure
Greatbatch Medical is recalling Standard Offset Cup Impactors with POM-C handle grips because they failed sterility testing when sterilized according to the Instructions for Use.
Product
Greatbatch, Offset Cup Impactor with the following Parts and Catalogue #: Tl0600 ~ MMP3100CHA04 T10491 MIMP3100CHA04 T12230 M2M1P3100CHA04 T15752 ~MMP3100CHA04 T15949 ~MMP3100CHA04 T17238 MMP3100CHA04 T9954 MMP3100CHA04 T9955 MMP3100CHA04 T8468…
Category
Medical Device
Distribution
8 states
SevereFDA (Devices)·Z-0660-2017·2016-12-07
Elekta Monaco RTP System Recalled for Incorrect Dose Calculation
Elekta is recalling 671 Monaco RTP Systems because the reset function may calculate an incorrect dose for external beam radiation therapy plans.
Product
Monaco RTP System; Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Category
Medical Device
Distribution
26 states
HighFDA (Devices)·Z-0684-2017·2016-12-07
MicroPort Dynasty Liners Recalled Due to Metal Debris Tissue Reaction Risk
MicroPort Orthopedics is recalling 6,250 Dynasty Liners used in hip replacements due to an increasing trend of suspected tissue reactions to metal debris.
Product
Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF DLCOGE40, REF DLCOGF42, REF DLCOGG44, REF DLCOGH48, REF DLCOGJ52, REF DLCOGK56, For use with the conserve metal head
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0673-2017·2016-12-07
Roche OMNI S Cassette Recall for Incorrect Urea Measurement Results
Roche is recalling 97 MSS Cassette units for the OMNI S Analyzer due to a software error that may cause incorrect urea results, potentially delaying diagnosis of inborn disorders in children.
Product
MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0666-2017·2016-12-07
Hamilton Medical Recalls MR1 Ventilators Due to Oxygen Tubing Loosening Risk
Hamilton Medical is recalling 44 MR1 ventilators because the oxygen tubing and connector could become loose during preparation, potentially compromising ventilation support.
Product
Hamilton-MR1 Ventilator: Catalog# 161010 The Hamilton MR1 Ventilator is intended to provide pressure ventilator support to adults and pediatrics, and optionally infants and neonates. Intended areas of use include: MRI Dept., Intensive, intermediate, emergency and long-term…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0677-2017·2016-12-07
Teleflex Recalls Arrow OnControl Bone Lesion Biopsy System Trays
Teleflex Medical is recalling Arrow OnControl Bone Lesion Biopsy System trays due to a potential incomplete seal on the outer sterile package.
Product
ARROW OnControl Bone Lesion Biopsy System Tray, Sterile, Rx only, The Arrow OnControl Bone Lesion Biopsy System is intended for bone biopsy of the vertebral body and bone lesions.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0665-2017·2016-12-07
Merge Healthcare Recalls Hemo Software Due to Potential Application Crashes
Merge Healthcare is recalling Merge Hemo software versions 9.10 through 9.40.2 because the application may crash during cardiac catheterization procedures.
Product
Merge Hemo software. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheterization procedure. The Monitoring System is for the monitoring of vital parameters including ECG, SpO2, invasive blood pressure, temperature…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0690-2017·2016-12-07
Domain Surgical Recalls FMsealer Open Shears Due to Jaw Fractures
Domain Surgical is recalling FMsealer Open Shears (Model FM3001) because fixed jaw fractures were observed during clinical usage.
Product
FMsealer Open Shears. Model FM3001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0688-2017·2016-12-07
MicroPort Orthopedics Recalls Conserve Cups Due to Metal Debris Tissue Reaction
MicroPort Orthopedics is recalling Conserve Cups because revision rate trends indicate a specific hazard of tissue reaction to metal debris.
Product
Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF 38BF4450, REF 38BF4450SP, REF 38BF4652, REF 38BF4652SP, REF 38BF4854, REF 38BF5056, REF 38BF5258, REF 38BF5258SP, REF 38BF5460, REF…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0686-2017·2016-12-07
MicroPort Lineage Shell Recalled Due to Metal Debris Tissue Reaction Risk
MicroPort Orthopedics is recalling 22 Lineage Shell units due to an increasing trend in revision rates and a specific hazard of tissue reaction to metal debris.
Product
Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 36695464 For use with the conserve metal head
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0676-2017·2016-12-07
Teleflex Recalls Arrow OnControl Bone Marrow Biopsy Systems for Sterility Concerns
Teleflex Medical is recalling Arrow OnControl Bone Marrow Biopsy Systems due to a potential incomplete seal on the outer sterile package.
Product
ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0678-2017·2016-12-07
Teleflex Recalls OnControl Biopsy System Ported Needle Trays for Sterility Concerns
Teleflex Medical is recalling OnControl Biopsy System Ported Needle Trays due to a potential incomplete seal on the outer sterile package.
Product
OnControl Biopsy System Ported Needle Tray, Sterile, Rx only, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow OnControl Bone Marrow Biopsy System is intended for bone marrow…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0687-2017·2016-12-07
MicroPort Recalls Conserve Hip Shells Due to Metal Debris Tissue Reaction
MicroPort Orthopedics is recalling Conserve hip shells because revision rate trends indicate a specific hazard of tissue reaction to metal debris.
Product
Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021156, REF 38021158, REF 38021160, REF 38021162, REF 38021164, REF 38023642, REF 38023646, REF 38023844, REF 38023848, REF 38024046, REF 38024050, REF 38024248, REF 38024252, REF…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0691-2017·2016-12-07
B. Braun Recalls Sterile IV Start Kits Due to Sterility Testing
B. Braun Medical is recalling 15,950 Sterile IV Start Kits because non-routine sterility testing returned positive results.
Product
Sterile IV Start Kits 50 units/trays per case Convenience kit for IV start procedures
Category
Medical Device
Distribution
Distributed nationwide

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20426–20450 of 27647