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

27576–27600 of 27722

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
HighFDA (Devices)·Z-1950-2012·2012-07-18
Drager PT 4000 Phototherapy System Recalled for Incorrect Fuse Rating
Draeger Medical Systems is recalling 65 Drager PT 4000 Phototherapy Systems because they contain a 16 Amp fuse instead of the specified 1.6 Amp fuse, posing a risk of overheating.
Product
Drager PT 4000 Phototherapy System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1956-2012·2012-07-18
Civco VirtuTRAX Electromagnetic Sensor Recall Due to Calibration Error
Civco Medical Instruments is recalling 24 VirtuTRAX Instrument Navigator kits because incorrect sensor calibration may cause variability in projected needle paths during ultrasound procedures.
Product
CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX Instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 610-1080. The firm name on…
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1977-2012·2012-07-18
Abbott i-Stat Analyzer Recall for Excessive Heat in Battery Area
Abbott Point of Care is recalling i-Stat Analyzers because the battery area can become uncomfortably hot to touch. This is a recall extension.
Product
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1946-2012·2012-07-18
Argon Safedraw Venous Close Loop System Recalled for Pouch Seal Defect
Argon Medical Devices is recalling 10 Safedraw Venous Close Loop System blood sampling sets in Missouri due to a potential pouch seal defect that may compromise the sterile barrier.
Product
Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte. Ltd., 198 Yishun Avenue 7, Singapore 768028. The blood sampling set is intended to be used for closed-loop blood sampling from…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1954-2012·2012-07-18
CIVCO General Purpose Sensor Recalled for Calibration Errors
Civco Medical Instruments is recalling 100 CIVCO General Purpose Sensors because incorrect calibration may cause variability in the projected position of the needle path.
Product
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 610-1066. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part…
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1953-2012·2012-07-18
Civco General Purpose Sensor Recalled for Calibration Errors
Civco Medical Instruments is recalling 30 kits of General Purpose Sensors due to incorrect calibration that may cause variability in needle path projection.
Product
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 10441627. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part…
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1948-2012·2012-07-18
ArjoHuntleigh Recalls Chorus Mobile Patient Lifters Due to Injury Risk
ArjoHuntleigh is recalling specific Chorus Mobile Patient Lifters because an exposed metal support bracket can cause injuries when the knee pad assembly is removed.
Product
Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5060-21US, KKB5062-21US and KKB5080-21US. The Chorus is designed to be used as a standing and raising aid, it is useful for short transfers from one…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1957-2012·2012-07-18
Terumo Advanced Perfusion System 1 Central Control Module Recall
Terumo is recalling 992 Central Control Modules for the Advanced Perfusion System 1 due to reports of partial or full functionality loss.
Product
Central Control Module for System 1: 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…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2000-2012·2012-07-18
Philips Intellispace Portal software recalled for tumor measurement errors
Philips Medical Systems is recalling Intellispace Portal software because tumor measurements are not recalculated when lesion contours are edited.
Product
Intellispace Portal software Product Usage: Intellispace Portal is a multimodality thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. Intellispace Portal is a medical software system that allows multiple users…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1965-2012·2012-07-18
Terumo Advanced Perfusion System 1 Recalled for Battery Depletion Issues
Terumo is recalling approximately 993 Advanced Perfusion System 1 units because the battery may deplete faster than expected during shutdown, potentially causing unexpected system failure.
Product
System 1 Base, 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in 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
41 states
HighFDA (Devices)·Z-1973-2012·2012-07-18
Abbott i-Stat Analyzers Recalled Due to Excessive Heat in Battery Area
Abbott Point of Care is recalling i-Stat Model 200 and 300 analyzers because they may become uncomfortably hot to touch near the battery.
Product
iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1952-2012·2012-07-18
Civco VirtuTRAX Electromagnetic Sensor Recalled for Calibration Errors
Civco Medical Instruments is recalling 221 VirtuTRAX kits because the electromagnetic sensors were incorrectly calibrated, which may cause variability in projected needle paths.
Product
CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 5350925. The firm name on the…
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1947-2012·2012-07-18
Arjo Encore Mobile Patient Lifter Recalled for Exposed Metal Bracket Injury Risk
ArjoHuntleigh is recalling specific Encore Mobile Patient Lifters because removing the knee pad assembly can expose a metal support bracket, posing an injury risk to patients.
Product
Encore Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5022-21US and KKB5042-21US. The Encore is designed to be used as a standing and raising aid, it is useful for short transfers from one sitting position…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1960-2012·2012-07-18
GE Healthcare Recalls CT/PET Fusion Software Due to Image Alignment Issues
GE Healthcare is recalling CT/PET Fusion software versions 4.0, 4.1, and 4.2 because fused CT and PET images may be incorrectly aligned.
Product
GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software. (Version 4.0, 4.1,or 4.2) The Advantage CT/PET Fusion clinical application provides easy comparison of three dimensional (3D) anatomical images from Computed…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1972-2012·2012-07-18
GE Healthcare Recalls enFlow IV Fluid Warmer Straps for Biocompatibility Issues
Vital Signs Devices is recalling enFlow Warmer Straps because they do not meet biocompatibility standards for skin contact.
Product
enFlow IV Fluid Warmer (510k name: EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120). The Enginivity enFlow TM IV Fluid Warmer is intended for warming blood, blood products and intravenous solutions prior to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1976-2012·2012-07-18
Abbott i-STAT1 Abaxis Analyzer Recalled for Overheating Battery Area
Abbott Point of Care is recalling i-STAT1 Abaxis Analyzers because the battery area can become uncomfortably hot to touch.
Product
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1951-2012·2012-07-18
Encision Recalls AEM Disposable Electrodes Due to Unanticipated Alarms
Encision, Inc. is recalling 48 boxes of AEM Disposable Electrodes after two complaints reported unanticipated alarms from the AEM monitor, which could cause delays or complications during surgery.
Product
AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical…
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1986-2012·2012-07-18
Philips HeartStart MRx Defibrillator Recalled for ECG Analysis Failure
Philips is recalling 35 HeartStart MRx defibrillators because they cannot analyze ECG reports during 12-lead acquisition.
Product
Philips HeartStart MRx M3536A Defibrillator/Monitor with Software R.03.03 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and…
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-2002-2012·2012-07-18
Elekta Focal SIM Planning Software Recalled for Incorrect Patient Shift Directions
Elekta, Inc. is recalling Focal SIM Planning software versions 4.64.00 through 4.700 due to incorrect patient shift directions in printed reports.
Product
Focal SIM Planning of radiation therapy
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1970-2012·2012-07-18
Terumo Advanced Perfusion System 1 Recalled for Roller Pump Malfunctions
Terumo CVS is recalling 992 units of the Advanced Perfusion System 1 due to roller pump malfunctions that could require backup equipment during surgery.
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 who…
Category
Medical Device
Distribution
Distributed nationwide

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27576–27600 of 27722