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 deaths or serious injuries are reported, 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.

Filters

Agency

Category

Minimum severity

Clear filters

476–500 of 582

  • CriticalFDA (Devices)·Z-0660-2016·2016-01-27

    St. Jude Medical Recalls Optisure Dual Coil Defibrillation Leads

    St. Jude Medical is recalling Optisure Dual Coil Defibrillation Leads due to potential insulation cuts in the SVC shock coil.

    Product
    Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0442-2016·2015-12-30

    Biomerieux Etest PIP/TAZO/CON-4 PTC 256 Recalled for Erroneous Results

    Biomerieux is recalling Etest PIP/TAZO/CON-4 PTC 256 antimicrobial susceptibility tests due to the potential for reporting false susceptible results for Piperacillin/Tazobactam.

    Product
    Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0360-2016·2015-12-23

    Draeger Perseus A500 Anesthesia Workstation Recalled for Power Switch Failure

    Draeger Medical is recalling 34 Perseus A500 Anesthesia Workstations because the main power switch may fail during use, causing ventilation or fresh gas delivery failures.

    Product
    Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.
    Category
    Medical Device
    Distribution
    6 states
  • CriticalFDA (Devices)·Z-0271-2016·2015-12-02

    Alcon AcrySof IQ Toric IOL Recall Expanded for Post-Operative Inflammation

    Alcon Research, Ltd. is expanding a recall of AcrySof IQ Toric intraocular lenses due to increased reports of post-operative inflammation in patients.

    Product
    Expansion of previous recall of AcrySof IQ ReSTOR and AcrySof IQ ReSTOR Toric IOL; now to include AcrySof IQ Toric models SN6AT6, SN6AT7, SN6AT8, and SN6AT9. Intended for primary implantation in the capsular bag of the eye for visual correction.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0151-2016·2015-11-11

    Hamilton Medical Recalls HAMILTON-G5 Ventilators Due to Alarm Suppression Defect

    Hamilton Medical is recalling 1,128 HAMILTON-G5 ventilators because suctioning maneuvers can unintentionally suppress ventilation and alarms.

    Product
    HAMILTON-G5 Ventilator with software versions between V2.00 and V2.31. Anesthesiology: The HAMILTON-G5 ventilator is designed for intensive care ventilation of adult and pediatric patients, and optionally infant and neonatal patients
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2731-2015·2015-09-23

    SynCardia Recalls Freedom Drivers for Potential Drive Mechanism Failure

    SynCardia Systems is recalling Freedom Drivers because a component may fail, causing the drive mechanism to stop pumping and resulting in the loss of life-sustaining function.

    Product
    Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of immine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2372-2015·2015-08-26

    Elite Biomedical Recalls Alaris Medley LVP Bezel Assemblies

    Elite Biomedical Solutions LLC is recalling 346 Alaris Medley LVP Bezel Assemblies used in infusion pumps due to a risk of administering inappropriate fluid quantities.

    Product
    Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and help protect the bezel assembly's internal components from fluid intrusion. This part is used in the Alaris Medley LVP 8100 infusion pump.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2367-2015·2015-08-26

    Teleflex Medical Recalls Sheridan Sher-I-BRONCH Endobronchial Tubes

    Teleflex Medical is recalling Sheridan Sher-I-BRONCH endobronchial tubes because the double swivel connector may crack or separate.

    Product
    HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring br
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2069-2015·2015-07-29

    Western OxyTOTE Portable Oxygen System Regulators Recalled for Ignition Risk

    Western / Scott Fetzer Company is recalling OxyTOTE Portable Oxygen System regulators due to a risk of ignition and rupture of the oxygen cylinder.

    Product
    Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes and is designed to provide mobility with a self-contained supply
    Category
    Medical Device
    Distribution
    47 states
  • CriticalFDA (Devices)·Z-1951-2015·2015-07-15

    Shiley Pediatric Tracheostomy Tubes Recalled for Breathing Difficulties

    FDA recalls Shiley tracheostomy tubes due to reports of patient discomfort and breathing difficulties.

    Product
    Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. Intended for use in providing tracheal access for airway managements.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1818-2015·2015-06-24

    Hill-Rom Viking Mobile Patient Lifts Recalled for Potential Free Fall Hazard

    Hill-Rom is recalling Viking M, L, and XL Mobile Lifts because a damaged actuator can cause the lift arm to drop suddenly, posing a risk of patient injury or death.

    Product
    Viking M, L, and XL Mobile Lifts. Non-AC-powered patient lift.
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1706-2015·2015-06-17

    Maquet FLOW-i Anesthesia System Recalled for Gas Leakage Risk

    Maquet is recalling FLOW-i Anesthesia Systems because a dislodged patient cassette can cause gas leakage and stop ventilation.

    Product
    FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
    Category
    Medical Device
    Distribution
    12 states
  • CriticalFDA (Devices)·Z-1726-2015·2015-06-17

    HeartWare Ventricular Assist System Recalled for Driveline Connector Pin Retraction

    HeartWare Inc is recalling HVAD systems due to complaints about pin retraction within the driveline connector. The recall affects 3,747 units currently in use worldwide.

    Product
    HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure.
    Category
    Medical Device
    Distribution
    32 states
  • CriticalFDA (Devices)·Z-1462-2015·2015-04-29

    Laax Recalls TIGERPAW System II Implantable Occlusion Fasteners

    Laax, Inc. is recalling TIGERPAW System II implantable fasteners due to reports of tissue tearing and bleeding during use.

    Product
    TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1035-2015·2015-02-25

    GE Healthcare MRI Systems Recalled for Potential Ferrous Object Removal Delay

    GE Healthcare is recalling MRI systems because a disconnected MRU could delay the removal of ferrous objects, posing a life-threatening injury risk.

    Product
    This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1051-2015·2015-02-18

    Teleflex Recalls MAQUET SERVO Humidifiers Due to Cracked Flex Tubes

    Teleflex Medical is recalling MAQUET SERVO Humidifier 163 units because cracks may occur in the corrugated flex tube, posing a risk to patients.

    Product
    MAQUET, SERVO Humidifier 163, Rx Only, Inmed Mfg. Sdn Bhd. Catalog No: XKC01-06-8125-8, Model No. 01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tu
    Category
    Medical Device
    Distribution
    4 states
  • CriticalFDA (Devices)·Z-0311-2015·2014-12-10

    Customed Minor Laparotomy Packs Recalled Due to Compromised Sterility

    Customed, Inc. is recalling 625 Minor Laparotomy Packs because compromised sterility and manufacturing deficiencies may result in patient infection.

    Product
    Minor Laparotomy Pack, Catalog number 900-1735. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-0461-2015·2014-12-10

    ConMed Pediatric Multifunction Electrodes Recalled for Connection Design Flaws

    ConMed is recalling Pediatric R2 Multifunction Electrodes because design changes to the connection with Philips Heartstart devices may cause connection failures, potentially delaying therapy and leading to patient death or serious injury.

    Product
    CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED IN MEXICO -Intended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0458-2015·2014-12-10

    ConMed Adult Radiotransparent Electrode Recall Due to Connection Failure Risk

    ConMed is recalling Adult Radiotransparent Electrodes because design changes to Philips AEDs may prevent connection, delaying therapy and risking patient death or serious injury.

    Product
    ADULT Radiotransparent Electrode, REF/Catalog Number 2516H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0459-2015·2014-12-10

    ConMed Pediatric Radiotransparent Electrode Recall Due to Connection Design Changes

    ConMed is recalling 174,610 pediatric radiotransparent electrodes because design changes to Philips AED connections may cause therapy delays, risking patient death or serious injury.

    Product
    PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2603H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0455-2015·2014-12-10

    ConMed Adult Radiotransparent Electrode Recall Due to Connection Design Changes

    ConMed is recalling Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause connection failures, potentially delaying therapy and resulting in patient death or serious injury.

    Product
    ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0456-2015·2014-12-10

    ConMed Adult Radiotransparent Electrodes Recalled for Connection Design Changes

    ConMed is recalling 174,610 Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause therapy delays, risking patient death or serious injury.

    Product
    ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0296-2015·2014-12-10

    Customed Laparotomy Packs Recalled Due to Compromised Sterility and Contamination Risk

    Customed, Inc. is recalling 892 Laparotomy Packs (Catalog 900-149) because compromised sterility and inadequate storage conditions may result in patient infection.

    Product
    Laparotomy Pack, Catalog number 900-149. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-0383-2015·2014-12-10

    Customed Minor Laparotomy Packs Recalled for Sterility Compromise

    Customed, Inc. is recalling 250 Minor Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.

    Product
    Minor Laparotomy Pack, Catalog number 900-450. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
    Category
    Medical Device
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-0457-2015·2014-12-10

    ConMed Adult Radiotransparent Electrode Recall Due to Connection Design Changes

    ConMed is recalling 174,610 Adult Radiotransparent Electrodes because design changes to Philips AED connections may cause therapy delays, risking patient death or serious injury.

    Product
    ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR
    Category
    Medical Device
    Distribution
    Distributed nationwide