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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26351–26375 of 27686

  • HighFDA (Devices)·Z-1646-2013·2013-07-10

    Philips CT Scanners Recalled for Image Artifacts Impairing Diagnostic Quality

    Philips is recalling Brilliance CT 64 and Ingenuity Core scanners due to software issues causing image artifacts that may impair diagnostic quality.

    Product
    Computed Tomography X-ray systems Product Usage: The Brilliance CT 64, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1622-2013·2013-07-10

    Maquet YUNO Mobile Operating Table Recall for Extension Device Handle Issue

    Maquet is recalling YUNO mobile operating tables and extension devices because the handle design may allow operator skin to enter a gap.

    Product
    MAQUET Getinge Group Mobile Operating Table YUNO OTN GA 1433.01 EN 05. The YUNO OTN is used to support and position patients for surgical procedures immediately before, during and after the surgical phase. The table top is radio translucent and enables intraoperative use of…
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-1666-2013·2013-07-10

    SpineFrontier Recalls InSpan Inserter Assemblies Due to Set Screw Deformation

    SpineFrontier, Inc. is recalling InSpan Inserter assemblies because a set screw may become deformed. The recall covers 61 units distributed worldwide.

    Product
    InSpan Inserter, Right Assembly; InSpan Inserter, Left Assembly Product Usage: Inserters are stainless steel instruments that have an inner shaft. The left and right inserters are used in combination with each other to place the implants into the body. Inserters are used to…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1654-2013·2013-07-10

    HealthLink Biopsy Punches Recalled for Lack of Sterilization

    Clorox Healthcare Holdings is recalling HealthLink Biopsy Punches because they were not sterilized. The recall affects 1,044,600 units distributed in the US, Canada, Mexico, and New Zealand.

    Product
    HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1618-2013·2013-07-10

    Bard StatLock CV Plus Stabilization Devices Recalled for Assembly Error

    Bard Access Systems is recalling StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly that may cause skin irritation or catheter mis-orientation.

    Product
    StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock¿ device provides stabilization for compatible medical tubes and catheters.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1652-2013·2013-07-10

    Braemar Recalls Lithium Thionyl Battery Packs for ER920 Wireless Event Recorders

    Braemar, Inc. is recalling 3,286 non-rechargeable lithium thionyl battery packs used with ER920 Wireless Series Arrhythmia Event Recorders due to a battery-related incident.

    Product
    Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01 used with ER920 Wireless Series Arrhythmia Event Recorder. Non-rechargeable disposable battery pack.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1640-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls Reprocessed Medical Devices

    Surgical Instrument Service And Savings, Inc. is recalling 34 reprocessed medical devices because the sterile barrier seal became compromised, allowing product to fall out of the pouch.

    Product
    - ACCU-PASS Suture Shuttle, 70 Degree, Upbend, (Orange) Ref. 72200419 Lot 122504 - Carpal Tunnel Release Blade Assembly, (White) Ref. 81010 Lot 123263, 122406, 122482, 123043, 122518, 122511 - ENDO-SCRUB 2, (1) Sheath, 0 Degree, For K. Storz, Medtronic Sharpsite AC…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1630-2013·2013-07-10

    Surgical Instrument Service And Savings Recalls 73 Medical Devices with Compromised Sterile Seals

    Surgical Instrument Service And Savings, Inc. is recalling 73 surgical instruments and accessories because their sterile seals may be compromised, allowing product to fall out of the pouch.

    Product
    - Average Medium Blade 9mm x 25mm x 0.38mm Ref. 2296-3-111 Lot 122590, 122447 - Cannulated Drill Bit, Quick Coupling, For 3.5 & 4mm Cannulated Screws, 1.35mm Cannulation 2.7mm x 160mm Ref. 310.67 Lot 122289 - Hall MicroChoice, Oscillating Blade, Fine, Flat, Stainless…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1617-2013·2013-07-10

    Biosense Webster Recalls 20-Pole LASSO Nav Catheter Eco Due to Calibration Error

    Biosense Webster is recalling 10 units of the 20-Pole LASSO Nav Catheter Eco because incorrect calibration causes the CARTO 3 System to display them as 10-Pole devices.

    Product
    20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.
    Category
    Medical Device
    Distribution
    3 states
  • CriticalFDA (Devices)·Z-1570-2013·2013-07-03

    Medtronic SynchroMed II Pump Recall for Unintended Drug Delivery

    Medtronic is recalling SynchroMed II implantable infusion pumps due to a risk of unintended drug delivery during the priming bolus function, which may cause overdose or underdose symptoms.

    Product
    Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1575-2013·2013-07-03

    Medtronic Recalls INDURA 1P Intrathecal Catheters Due to Occlusion Risk

    Medtronic is recalling INDURA 1P Intrathecal Catheters because the previous connector design has a greater potential for misalignment and occlusion.

    Product
    Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length markers and guide wire, 15 T-gauge introducer needle, Sutureless pump connector with attached 7.6-cm catheter and Connector pin, Transparent Strain-relief sleeves, and anchors.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1580-2013·2013-07-03

    Medtronic SynchroMed EL Pumps Recalled for Electrical Shorting Risk

    Medtronic is recalling SynchroMed EL pumps due to potential internal electrical shorting that may cause therapy loss.

    Product
    Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1576-2013·2013-07-03

    Medtronic Recalls Sutureless Connector Intrathecal Catheters Due to Occlusion Risk

    Medtronic is recalling 115,722 Sutureless Connector Intrathecal Catheters worldwide because the previous design has a greater potential for misalignment and occlusion.

    Product
    Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length markings and guide wire, 66-cm pump segment, 15 T-gauge introducer needle, Transparent Strain-relief sleeves, Opaque Strain-relief sleeves, and V-wing anchors. Contents of inner package…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1571-2013·2013-07-03

    Medtronic SynchroMed EL Pumps Recalled for Unintended Drug Delivery

    Medtronic is recalling SynchroMed EL implantable pumps due to a risk of unintended drug delivery during the priming bolus function, which may cause overdose or underdose.

    Product
    Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion system that stores and delivers a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1579-2013·2013-07-03

    Medtronic SynchroMed II Pumps Recalled for Electrical Shorting Risk

    Medtronic is recalling SynchroMed II pumps due to potential electrical shorting that may cause therapy loss or reduction.

    Product
    Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1574-2013·2013-07-03

    Medtronic Recalls Intrathecal Catheter Pump Segment Revision Kits

    Medtronic is recalling unused Model 8596SC Pump Segment Revision Kits due to a design flaw that increases the risk of catheter occlusion.

    Product
    Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segment with attached sutureless pump connector, Spinal Segment Strain-relief sleeves, Pump segment strain-relief sleeves, Connector pin. Contents of inner package are STERILE. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1586-2013·2013-07-03

    Medrad Recalls DC Power Cables for Veris MR Vital Signs Monitor

    Medrad Inc is recalling 1,066 DC power cables for the Veris MR Vital Signs Monitor due to a design issue that could cause shorting and heating.

    Product
    DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1573-2013·2013-07-03

    Medtronic Sutureless Pump Connector Revision Kit Recalled for Occlusion Risk

    Medtronic is recalling Sutureless Pump Connector Revision Kits due to a design flaw that increases the risk of catheter occlusion.

    Product
    Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump connector, catheter, connector pin, and strain-relief sleeve to be used with Medtronic SynchroMed implantable drug infusion pumps. Contents of inner…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1597-2013·2013-07-03

    RF Technologies Recalls Code Alert Advanced 4-Way Care Solution Due to Firmware Error

    RF Technologies is recalling 167 Code Alert Advanced 4-Way Care Solution units because a firmware error may delay alarm transmission to the server.

    Product
    Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1608-2013·2013-07-03

    Cordis RadialSource Spring Wire Transradial Access Kit Recalled for Undersized Tip

    Cordis and Greatbatch Medical are recalling one lot of RadialSource Spring Wire Transradial Access Kits because some units have an undersized vessel dilator tip that cannot slide over the guidewire.

    Product
    Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manufacturer Greatbatch Medical 2300 Berkshire Lane North, Minneapolis, MN 55441, Distributor Cordis Corporation 14201 North West 60th Avenue, Miami Lakes, Florida 33014. Baxter's lnfusors SV…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1566-2013·2013-07-03

    Loma Vista Medical Recalls TRUE Dilatation Balloon Valvuloplasty Catheters

    Loma Vista Medical is recalling TRUE Dilatation Balloon Valvuloplasty Catheters because they deflate slower than the specified maximum of 10 seconds.

    Product
    TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; Intended to be used for balloon aortic valvuloplasty.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1583-2013·2013-07-03

    Roche Recalls CoaguChek XS Plus Systems Due to Potential Test Errors

    Roche is recalling CoaguChek XS Plus systems because they may display an error message instead of a value, potentially leading to undetected elevated INR results.

    Product
    CoaguChek XS Plus System The CoaguChek XS Plus system for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2013·2013-07-03

    Roche Recalls CoaguChek XS Pro Systems Due to Potential Test Errors

    Roche is recalling 537 CoaguChek XS Pro Systems because they may display an error message instead of a prothrombin time value.

    Product
    CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek XS Pro meter and CoaguChek XS PT Test strips) quantitatively determines prothrombin time ("PT"), using capillary blood or whole blood from a vein (non anticoagulated venous whole blood).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2013·2013-07-03

    Medtronic Recalls INFUSE Bone Graft Kits Due to Endotoxin Levels

    Medtronic is recalling INFUSE Bone Graft kits because they contain a collagen sponge with possible elevated endotoxin levels.

    Product
    INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopaedic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1603-2013·2013-07-03

    Baxter Recalls Intermate Infusion Pumps Due to Rupture Complaints

    Baxter Healthcare is recalling Intermate Infusion Pumps due to an increase in rupture complaints. The recall covers 3,255,096 units distributed nationwide and in Puerto Rico.

    Product
    Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.
    Category
    Medical Device
    Distribution
    Distributed nationwide