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

40126–40150 of 40356

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
ModerateFDA (Devices)·Z-2011-2012·2012-07-25
Stingray Surgical Recalls Bipolar Forceps Due to Uncleared Instructions
Stingray Surgical Products is recalling bipolar forceps because the Instructions For Use were altered without FDA clearance.
Product
Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps. Bipolar Forceps designed to grasp, manipulate and coagulate selected tissue for use in general surgical…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2012-2012·2012-07-25
Critical Diagnostics Recalls Presage ST2 Assay Kits Due to Inaccurate Results
Critical Diagnostics is recalling Presage ST2 Assay kits because they may produce inaccurate test results for patients with chronic heart failure.
Product
Presage ST2 Assay, catalog numbers BC-1065 and BC-1065E. The Critical Diagnostics Presage ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbent assay (ELISA) in a microtiter plate format. The Presage…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1993-2012·2012-07-25
GE Healthcare Recalls Optima Mobile X-ray Systems Due to Software Issue
GE Healthcare is recalling Optima XR200 and XR220 mobile X-ray systems because a software issue affects the visual indication required by regulations.
Product
GE Healthcare Optima Mobile X-ray System. The GE Automatic Mobile X-Ray (AMX ) Series are intended to take exposures utilizing film or computed radiography ( CR )
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2029-2012·2012-07-25
Gulf Fiberoptics Recalls GMF-RC65 Surgical Headlight Cables
Gulf Fiberoptics, Inc. is recalling 169 GMF-RC65 Replacement Surgical Headlight Cables because the light-transmitting fiber material differs from the approved 510(k) design.
Product
GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink. GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink is used to transmit light.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2032-2012·2012-07-25
Becton Dickinson Recalls Gram Crystal Violet Stain Reagents
Becton Dickinson is recalling Gram Crystal Violet 250 mL reagents due to potential artifacts that may interfere with the identification of microorganisms.
Product
Gram Crystal Violet 250 mL, catalog #212525, in cartons of 4 bottles. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram method.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2028-2012·2012-07-25
Integra Jarit Take-Apart Endoscopic Instruments Recalled for Component Defect
Integra Limited is recalling 108 Take-Apart Endoscopic Instruments because internal shaft components were out of specification.
Product
Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2013-2012·2012-07-25
Abbott Molecular Bar Code Scanner User's Guide Recalled for Incorrect Bar Codes
Abbott Molecular is recalling the Bar Code Scanner User's Guide because incorrect bar codes may prevent proper language configuration of the scanner.
Product
Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component of the Abbott m2000 Instrument System; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list number 06L88-02. Language configuration bar codes - Intended…
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-2031-2012·2012-07-25
Becton Dickinson Recalls BD Gram Stain Kits Due to Staining Artifacts
Becton Dickinson is recalling 539 BD Gram Stain Kits because increased artifacts may interfere with the distinction between microorganisms.
Product
BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2008-2012·2012-07-25
DeRoyal Recalls Surgical Kits Due to Missing Protective Tape
DeRoyal Industries is recalling 303 custom surgical kits and trays because clear protective tape was not applied during manufacturing.
Product
Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2030-2012·2012-07-25
Sigma Recalls Infusion Pump Master Drug Library Editor Software
Sigma issued a safety alert for the SIGMASpectrum Infusion Pump Master Drug Library Editor software because it may create drug libraries that do not reflect common clinical practices.
Product
SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.
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
SevereFDA (Devices)·Z-1928-2012·2012-07-18
Alere Triage CardioProfiler Panel Recalled for Decreased Precision
Alere San Diego, Inc. is recalling 16,962 kits of the Alere Triage CardioProfiler Panel due to decreased precision that may cause false positive or negative results.
Product
Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1932-2012·2012-07-18
Alere Triage D-dimer Kits Recalled for Decreased Precision
Alere San Diego is recalling 1,972 Triage D-dimer kits because certain lots may have decreased precision, potentially leading to false positive or negative results.
Product
Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2001-2012·2012-07-18
superDimension Systems Software Recall Due to Locatable Guide Malfunction
superDimension, Inc. is recalling Systems with Software Version 4.0-4.9 because they fail to recognize the Locatable Guide.
Product
superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1989-2012·2012-07-18
GE Axcess Cranial Screw Recalled Due to Breakage During Insertion
GE Healthcare is recalling 15 kits of Axcess Cranial Screws because they may break during insertion, posing a potential health hazard.
Product
The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is an accessory used in conjunction with the Axcess Cranial Tri-Pin Kit. The Axcess Bone (Cranial) Pin is intended to be used when rigid fixation of a…
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1967-2012·2012-07-18
Edwards Lifesciences Recalls Rigid Suction Wands Due to Tip Detachment Risk
Edwards Lifesciences is recalling Rigid Suction Wands (models S033 and SPC2081) because the plastic tip may detach during use.
Product
Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular…
Category
Medical Device
Distribution
Distributed nationwide

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40126–40150 of 40356