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

27501–27525 of 27681

HighFDA (Devices)·Z-2046-2012·2012-07-25
Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions
Terumo is recalling 461 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
Product
Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modular Perfusion System 8000 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2036-2012·2012-07-25
Teleflex Medical Recalls Hudson RCI Concha Therm Neptune Humidifiers
Teleflex Medical is recalling Hudson RCI Concha Therm Neptune Humidifiers because a speaker failure could prevent audio alarms from sounding, potentially delaying patient treatment.
Product
Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usage: Device that is intended to add moisture to, and sometime to warm, the breathing gases for administration to a patient.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2025-2012·2012-07-25
GE OEC 9900 Elite C-arm System Recalled for Power Supply Defect
GE OEC recalled 726 OEC 9900 Elite C-arm systems worldwide due to a defective vertical lift column power supply identified during an FDA inspection.
Product
OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm System, OEC 9900 Elite NAV used as an aid to locate anatomical structures during open or percutaneous surgical procedures. The system is an aid to locate anatomical structures during open or percutaneous surgical procedures.…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2045-2012·2012-07-25
Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions
Terumo is recalling Sarns Modular Perfusion System 8000 units due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
Product
Sarns Modular Perfusion System 8000 base, 5 pump 115V. The Sarns Modular Perfusion Systern 8000 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-2043-2012·2012-07-25
Terumo Advanced Perfusion System 1 recalled for air bubble detection malfunctions
Terumo is recalling 648 Advanced Perfusion System 1 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and oversensitivity.
Product
Terumo Advanced Perfusion System 1. System 1 base 220/240V. The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only When used by a qualified…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2023-2012·2012-07-25
EKOS MACH4 Endovascular Device Recalled for Catheter Marker Dislodgement
EKOS Corporation is recalling EkoSonic MACH4 Endovascular Devices because radio-opaque marker bands may dislodge and the MicroSonic Device may break during use.
Product
EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150) is a catheter, continuous infusion. it consists of the Intelligent Drug Delivery Catheter (IDDC) and the…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2052-2012·2012-07-25
Terumo Sarns Modular Perfusion System 9000 Recalled for Air Bubble Detection Malfunctions
Terumo is recalling 31 Sarns Modular Perfusion System 9000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
Product
Sarns Modular Perfusion System 9000, 100V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2010-2012·2012-07-25
Terumo Advanced Perfusion System 1 Recalled for Network Communication Failures
Terumo is recalling 648 Advanced Perfusion System 1 units due to reports of communications or power failures in the system network.
Product
Terumo Advanced Perfusion System 1 System 1 Base, 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2016-2012·2012-07-25
Stryker Recalls T2 Knee Arthrodesis Nails Due to Sterile Barrier Breach Risk
Stryker is recalling 532 units of T2 Knee Arthrodesis Nails because of a potential breach in the sterile packaging barrier.
Product
Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2035-2012·2012-07-25
Philips Brilliance CT Scanners Recalled for Defective Carbon Table Top Bolts
Philips Medical Systems is recalling 524 Brilliance CT scanners because defective bolts securing the carbon table top may break off.
Product
Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomography X-Ray Systems. The devices are Computed Tomography Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2033-2012·2012-07-25
Stryker AVS Navigator Trials Recalled for Shaft Failure
Stryker Spine is recalling AVS Navigator Trials because the shaft may fail at the junction of the trial head.
Product
Stryker AVS Navigator Trials 6mm-15mm Manufactured by: Stryker Spine SAS Z.1 Marticot-33610-Cestas -France +33 (0) 5.57.97.06.30 http;//www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Court. Allendale NJ 07401-1677 USA +1-201-780-8000 Cestas France…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2015-2012·2012-07-25
GE Healthcare Recalls Invasive Blood Pressure Care Cables
GE Healthcare is recalling 279 invasive blood pressure care cables due to a faulty O-ring that prevents correct blood pressure monitoring.
Product
GE Healthcare, Invasive Blood Pressure Care Cables. Product ID Number: 2016995-001, 2016995-002, 2016995-003, 2016995-004.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2042-2012·2012-07-25
Terumo Advanced Perfusion System Recalled for Air Bubble Detection Malfunctions
Terumo is recalling 992 Advanced Perfusion System I units worldwide due to reported malfunctions in the Air Bubble Detection System, including oversensitivity and false alarms.
Product
Terumo Advanced Perfusion System 1. System 1 base 100/120V. The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only When used by a qualified…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2047-2012·2012-07-25
Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions
Terumo is recalling 310 Sarns Modular Perfusion System 8000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
Product
Sarns Modular Perfusion System 8000 base, 5 pump 220/240V. The Sarns Modular Perfusion System 8000 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2039-2012·2012-07-25
Alere Triage Tox+MTD Drug Screen Recalled for Decreased Precision and Accuracy
Alere San Diego is recalling 9,997 Triage Tox+MTD Drug Screen kits because they may produce false positive or negative results due to decreased precision and accuracy.
Product
Alere Triage Tox+MTD Drug Screen, PN 94400 Product Usage: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2018-2012·2012-07-25
Kimberly-Clark Recalls MicroCool Surgical Gowns Due to Fabric Defects
Kimberly-Clark is recalling specific lots of MicroCool surgical gowns because they pill, lint, or allow blood to pass through.
Product
MicroCool Breathable Impervious Gown with Secure Fit Surgical, (Large and X-Large), Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2048-2012·2012-07-25
Terumo Sarns Modular Perfusion System 8000 Recalled for Air Bubble Detection Malfunctions
Terumo is recalling 26 Sarns Modular Perfusion System 8000 units due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
Product
Sarns Modular Perfusion System 8000 base, 4 pump 100V. The Sarns Modular Perfusion System 8000 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-2051-2012·2012-07-25
Terumo Sarns Modular Perfusion System 9000 Recalled for Air Bubble Detection Malfunctions
Terumo Cardiovascular Systems is recalling 286 Sarns Modular Perfusion System 9000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
Product
Sarns Modular Perfusion System 9000, 220/240V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2020-2012·2012-07-25
Terumo Advanced Perfusion System 1 Recalled for Power Malfunction
Terumo is recalling 992 Advanced Perfusion System 1 units due to a power loss error message that may affect system stability during medical procedures.
Product
System 1 Base, 100/120V. 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 qualified medical professional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2017-2012·2012-07-25
Kimberly-Clark Recalls MicroCool Surgical Gowns Due to Material Defects
Kimberly-Clark is recalling specific lots of MicroCool surgical gowns because they pill, lint, or allow blood strikethrough, potentially compromising sterility.
Product
MicroCool Breathable Impervious Surgical Gown, (Large and X-Large), Sterile, Made in Honduras. The Kimberly Clark Micro COOL Surgical Gowns are sterile single use surgical apparel intended to be worn by heathcare professionals to help protect the patient and the healthcare…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2050-2012·2012-07-25
Terumo Sarns Modular Perfusion System 9000 Recalled for Air Bubble Detection Malfunctions
Terumo is recalling 484 Sarns Modular Perfusion System 9000 units worldwide due to reported malfunctions in the Air Bubble Detection System, including false alarms and over-sensitivity.
Product
Sarns Modular Perfusion System 9000, 115V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified perfusionist…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2019-2012·2012-07-25
Spacelabs Xprezzon Bedside Monitor Recalled for Display Disconnection
Spacelabs Healthcare is recalling 21 Xprezzon Bedside Monitors because specific key presses can cause patient parameters to disappear from the display.
Product
Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms. The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alert the user to alarm conditions that are reported by…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2021-2012·2012-07-25
Terumo Advanced Perfusion System 1 Recalled for Power Fluctuation Errors
Terumo is recalling 648 Advanced Perfusion System 1 units due to a Red X error indicating loss or fluctuation of internal power on one side of the base.
Product
System 1 Base, 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 qualified medical professional…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1980-2012·2012-07-18
Zimmer Recalls Pathfinder NXT Fixed Percutaneous Rod Holder Due to Cracking
Zimmer, Inc. is recalling Pathfinder NXT Fixed Percutaneous Rod Holders because the tip may crack or break during surgery.
Product
Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle) , Stainless Steel / Silicone Rubber, Rx only, non sterile. Product Usage: The rod is held by the instrument for inserting and guiding into the screw heads via percutaneous delivery during…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1931-2012·2012-07-18
Alere Triage BNP Kits Recalled for Potential Inaccurate Heart Failure Results
Alere San Diego, Inc. is recalling 30,083 Triage BNP kits nationwide due to decreased precision that may cause unpredictable false positive or negative results.
Product
Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure).
Category
Medical Device
Distribution
Distributed nationwide

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27501–27525 of 27681