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

32926–32950 of 40325

SevereFDA (Devices)·Z-1609-2015·2015-06-03
CareFusion AVEA Ventilator Recalled for Pressure Transducer Failure
CareFusion is recalling AVEA ventilators because a pressure transducer failure can stop ventilation. Nonbreathing patients may require manual ventilation or a different device.
Product
CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1691-2015·2015-06-03
Biosense Webster Recalls SMARTABLATE RF Generator Systems Due to Unintended Energy Delivery
Biosense Webster is recalling 115 SMARTABLATE RF Generator Systems because two complaints reported the device inadvertently delivered RF energy during procedures.
Product
SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMART ABLATE Generator and all accessories is indicated in combination with compatible therapeutic catheters for use in conventional intracardiac RF ablation…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1655-2015·2015-06-03
Philips Brilliance CT 6 Air Systems Recalled for Unexpected Couch Descent
Philips is recalling 153 Brilliance CT 6 Air systems because the patient couch unexpectedly descended during exams. The units were distributed in China.
Product
Brilliance CT 6 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-1652-2015·2015-06-03
Philips Brilliance CT 16 Water Computed Tomography Systems Recalled for Couch Descent
Philips Medical Systems is recalling 153 Brilliance CT 16 Water systems because the patient couch may unexpectedly descend during an exam.
Product
Brilliance CT 16 Water. 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-1688-2015·2015-06-03
Terumo Advanced Perfusion System 1 Base Recalled for Power Loss
Terumo is recalling 1,713 Advanced Perfusion System 1 bases worldwide to address power loss issues. The recall involves design changes and switch protectors.
Product
Base for Terumo Advanced Perfusion System 1, 220/240V 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-1678-2015·2015-06-03
Halyard KimVent Closed Suction System Recalled for Potential Valve Defect
Halyard Health is recalling specific KimVent Turbo-Cleaning Closed Suction Systems for adults because a defective internal valve may allow air to leak from the ventilator circuit.
Product
KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE (Product Code 2271603); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, T-Piece (Product Code 227135).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1684-2015·2015-06-03
Codman 3000 Series Refill Set Recalled for Leaking Needles
Codman & Shurtleff, Inc. is recalling 5,463 units of the CODMAN 3000 Series Refill Set because the needles may leak from the hub connection.
Product
CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5 Huber Point Needles which are used in conjunction with a 50 mL…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1681-2015·2015-06-03
Medtronic Recalls SynchroMed II Implantable Pumps Due to Alarm Failure
Medtronic is recalling specific SynchroMed II implantable drug pumps because the audible alarm may stop working, potentially preventing patients from detecting issues.
Product
Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted…
Category
Medical Device
Distribution
Distributed nationwide
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

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32926–32950 of 40325