The Recall Desk

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.

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27526–27550 of 27681

  • 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
  • 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