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

27551–27575 of 27722

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
SevereFDA (Devices)·Z-1925-2012·2012-07-18
Maquet FLOW-i Anesthesia System Recalled for Technical Alarm Issue
Maquet is recalling 284 FLOW-i Anesthesia Systems because a technical alarm may be generated if the MAN/AUTO switch is not fully engaged.
Product
FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1983-2012·2012-07-18
Advanced Neuromodulation Systems Recalls Eon Mini Neurostimulation Devices
Advanced Neuromodulation Systems is recalling Eon Mini Neurostimulation devices due to a workmanship issue that can cause loss of communication or recharging, resulting in loss of pain relief.
Product
Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1981-2012·2012-07-18
Zimmer Recalls Pathfinder NXT Fixed Percutaneous Rod Holder Due to Cracking
Zimmer, Inc. is recalling the Pathfinder NXT Fixed Percutaneous Rod Holder because the tip may crack or break during surgery.
Product
Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight handle) Stainless Steel / Silicone Rubber, Rx only, non sterile. Product Usage: PathFinder NXT is a minimally invasive pedicle screw system. The PathFinder NXT System consists of various screws and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1985-2012·2012-07-18
GE OEC InstaTrak 3500 Plus Surgical Navigation System Software Recall
GE OEC Medical Systems recalled 86 InstaTrak 3500 Plus surgical navigation systems due to software-related issues. The recall was initiated in 2006 but recently classified by the FDA due to administrative delays.
Product
InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1930-2012·2012-07-18
Alere Triage Profiler SOB Panel Recalled for Decreased Precision
Alere San Diego, Inc. is recalling 5,013 kits of the Triage Profiler SOB Panel because certain lots may have decreased precision, potentially leading to false positive or negative results.
Product
Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1929-2012·2012-07-18
Alere Triage Cardiac Panel Recalled for Decreased Precision
Alere San Diego, Inc. is recalling 6,044 kits of the Alere Triage Cardiac Panel due to decreased precision that may cause false positive or negative results.
Product
Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens.
Category
Medical Device
Distribution
Distributed nationwide

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27551–27575 of 27722