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

33026–33050 of 40449

HighFDA (Devices)·Z-1677-2015·2015-06-03
Alere i Influenza A & B kits recalled for false negative risk
Alere Scarborough, Inc. is recalling specific lots of Alere i Influenza A & B kits due to a high invalid rate and increased risk of false negative results.
Product
Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Alere i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1649-2015·2015-06-03
Philips Brilliance CT 64 Systems Recalled for Unexpected Couch Descent
Philips is recalling 153 Brilliance CT 64 systems because the patient couch may unexpectedly descend during an exam.
Product
Brilliance CT 64. 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.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1665-2015·2015-06-03
United Surgical Associates Recalls Elastic Knee Supports for Missing Latex Label
United Surgical Associates is recalling 1,260 Elastic Knee Supports because they lack a caution label regarding latex content, posing a risk of allergic skin reactions.
Product
Elastic Knee Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1653-2015·2015-06-03
Philips Brilliance CT 16 Air Recalled for Unexpected Couch Descent
Philips is recalling 153 Brilliance CT 16 Air systems because the patient couch may unexpectedly descend to its lowest point during an exam.
Product
Brilliance CT 16 Air. 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.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1689-2015·2015-06-03
Maquet Quadrox-iD Adult Diffusion Membrane Oxygenator Recalled for Blood Leakage Risk
Maquet Cardiovascular is recalling Quadrox-iD Adult Diffusion Membrane Oxygenators due to a potential issue that could result in blood leakage from the gas outlet port.
Product
Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1679-2015·2015-06-03
RaySearch RayStation Software Recalled for Dose Calculation Errors
RaySearch Laboratories AB is recalling RayStation software versions 2.5 through 4.0 due to dose calculation issues in specific VMAT plans.
Product
RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment 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-1671-2015·2015-06-03
Stryker EliteCore Biopsy Device Recalled for Cannula Overthrow Risk
Stryker is recalling EliteCore Full Core Biopsy Devices because the cannula may extend past its intended length.
Product
EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1656-2015·2015-06-03
Philips Brilliance iCT CT Systems Recalled for Unexpected Couch Descent
Philips Medical Systems is recalling 153 Brilliance iCT computed tomography systems because the patient couch may unexpectedly descend during an exam.
Product
Brilliance iCT. 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.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1672-2015·2015-06-03
DePuy LCS COMPLETE RPS Femoral Implants Recalled for Patello-femoral Pain Risk
DePuy Orthopaedics is recalling 19,059 LCS COMPLETE RPS Femoral Implants because they are associated with higher revision rates and potential patello-femoral pain when the native patella is not resurfaced.
Product
LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1673-2015·2015-06-03
DePuy LCS Knee Prosthesis Recalled for Higher Revision Rates
DePuy Orthopaedics is recalling LCS COMPLETE RPS knee inserts because they show higher revision rates in Australia when the patella is not resurfaced.
Product
LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1648-2015·2015-06-03
Philips Brilliance CT Big Bore Oncology Recalled for Unexpected Couch Descent
Philips Medical Systems is recalling 153 Brilliance CT Big Bore Oncology systems because the patient couch may unexpectedly descend during an exam.
Product
Brilliance CT Big Bore Oncology. 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.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1647-2015·2015-06-03
Philips MX8000 CT Scanner Recall Due to Unexpected Couch Descent
Philips is recalling 153 MX8000 CT scanners because the patient couch may descend unexpectedly during an exam.
Product
MX8000 Dualv. EXP, 728130. 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.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1683-2015·2015-06-03
OptiMedica Catalys Precision Laser System Software Recall for Incorrect Parameters
OptiMedica is recalling Catalys Precision Laser Systems with software version 3.00.05 because a software anomaly may provide incorrect cataract surgery parameters.
Product
Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1680-2015·2015-06-03
GE Healthcare Recalls D-Fend Water Traps Due to Occlusion Risk
GE Healthcare is recalling D-Fend and D-Fend+ water traps because they may occlude, causing a loss of respiratory gas monitoring.
Product
D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Product Usage: Water traps are intended to protect the GE monitor from humidity, secretions and bacterial contamination when…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1674-2015·2015-06-03
DePuy Spine Recalls EXPEDIUM Offset Conical Lock Nut Devices
DePuy Spine, Inc. is recalling 183 EXPEDIUM Offset Conical Lock Nut 8mm devices because they do not mate as intended.
Product
EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1654-2015·2015-06-03
Philips Brilliance CT 10 Air Recalled for Unexpected Couch Descent
Philips Medical Systems is recalling 153 Brilliance CT 10 Air systems in China because the patient couch may unexpectedly descend during an exam.
Product
Brilliance CT 10 Air. 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.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1686-2015·2015-06-03
Medrad Stellant CT Injector System Recalled for Under-Volume Hazard
Medrad Inc dba Bayer R&I is recalling 133 Stellant CT Injector Systems with Certegra Workstations due to a configuration error that may cause under-infusion of contrast media.
Product
MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1651-2015·2015-06-03
Philips Brilliance CT 16 Power Recalled for Unexpected Couch Descent
Philips is recalling 153 Brilliance CT 16 Power systems because the patient couch may unexpectedly descend during an exam.
Product
Brilliance CT 16 Power. 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.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1690-2015·2015-06-03
Maquet Cardiovascular Recalls HLS/HIT Set Advanced Due to Blood Leakage Risk
Maquet Cardiovascular is recalling HLS/HIT Set Advanced consoles because a potential issue could cause blood to leak from the gas outlet port.
Product
HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1657-2015·2015-06-03
Philips Ingenuity CT Recall for Unexpected Patient Couch Descent
Philips is recalling 153 Ingenuity CT systems in China because the patient couch unexpectedly descended to its lowest point during an exam.
Product
Ingenuity CT. 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.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1687-2015·2015-06-03
Terumo Advanced Perfusion System 1 Recalled for Power Loss Risk
Terumo is recalling 1,713 Advanced Perfusion System 1 units worldwide due to a risk of losing system power during critical medical procedures.
Product
100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1675-2015·2015-06-03
Mindray Recalls Panorama Patient Monitoring Network Due to Software Anomaly
Mindray is recalling four Panorama Patient Monitoring Network units due to a software anomaly that prevents arrhythmia alarms from displaying on the Panorama system after a restart.
Product
Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry System, which acquires and monitors physiological data for ambulating patients…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1669-2015·2015-06-03
Siemens Luminos Agile Max Imaging System Software Recall
Siemens is recalling 133 Luminos Agile Max imaging systems due to a software defect that causes image loss and connection issues.
Product
SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1661-2015·2015-06-03
Siemens Medical Solutions Recalls Direct Water Feed Kits Due to Quality Issue
Siemens Medical Solutions Diagnostics is recalling Direct Water feed Kits because a quality issue may prevent bottle caps from closing securely.
Product
Direct Water feed Kit, Catalog#10373222
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1668-2015·2015-06-03
Siemens Axiom Luminos dRF Max Recall for Software Data Loss
Siemens is recalling 133 Axiom Luminos dRF Max imaging systems due to a software defect that can cause acquired images to be deleted, requiring studies to be repeated.
Product
SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device…
Category
Medical Device
Distribution
Distributed nationwide

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33026–33050 of 40449