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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35676–35700 of 40449

  • ModerateFDA (Devices)·Z-1833-2014·2014-06-25

    Synthes External Fixation Systems Recalled for MR Labeling Changes

    Synthes, Inc. is recalling external fixation systems because labeling changes were made to reflect updated protocols for Magnetic Resonance (MR) imaging safety designations.

    Product
    Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1793-2014·2014-06-25

    Gen-Probe Recalls APTIMA Urine Collection Kits Due to Labeling Error

    Gen-Probe Inc is recalling APTIMA Urine Collection Kits because inner pouches are mislabeled as swab collection kits.

    Product
    APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1832-2014·2014-06-25

    Siemens VersaCell X3 Recall for Insecure Keyboard and Monitor Mounting

    Siemens Medical Solutions Diagnostics is recalling 19 VersaCell X3 robotic laboratory systems because the keyboard and monitor may not be properly secured to the monitor arm.

    Product
    VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes samples, reduces manual tasks and consolidates results.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1641-2014·2014-06-18

    Smiths Medical Recalls Mislabelled Portex Low Dead Space Connectors

    Smiths Medical ASD, Inc. is recalling one lot of Portex Low Dead Space Connectors with Sideport because 3.0mm devices were packaged and labeled as 3.5mm.

    Product
    Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space connector minimizes mechanical dead space and subsequent carbon dioxide rebreathing. The connector's…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1784-2014·2014-06-18

    Cordis EMPIRA RX PTCA Dilatation Catheter Recalled for Potential Bursting

    Cordis Corporation is recalling 80 units of EMPIRA RX PTCA Dilatation Catheters because they may exhibit radial versus axial tears if they burst during inflation.

    Product
    Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For cardiovascular use.
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-1733-2014·2014-06-18

    Siemens Vista Air Compressor Recalled for Fire and Shock Hazards

    Siemens Healthcare Diagnostics is recalling four Vista Air Compressors because miswiring could cause a fire or electrical shock if powered up.

    Product
    Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 10706557 SKIT Air Compressor Assy, used on the Dimension Vista 500 and Dimension Vista 1500 systems. Siemens Healthcare Diagnostics Dimension Vista System is an in vitro…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1756-2014·2014-06-18

    Stryker 3.0mm Round Fluted Bur Recalled for Missing Notches

    Stryker is recalling 285 sterile 3.0mm Round Fluted Bur Aggressive devices due to missing or partial notches. The defect may affect the device's compatibility with Elite Attachments.

    Product
    Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1747-2014·2014-06-18

    Neo Metrics Recalls NovaGold Guidewires Due to Tip Uncoiling Risk

    Neo Metrics, Inc. is recalling NovaGold High Performance Guidewires because the tip may uncoil or detach more frequently than anticipated. No illnesses or injuries have been reported.

    Product
    Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactured by NeoMetrics Inc, 2605 Fernbrook Lane Suite J, Plymouth, MN 55447. The NovaGold Guidewire is intended for use in selective cannulation…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1727-2014·2014-06-18

    Alere Triage D-Dimer Test Recalled for Incorrect Manufacturing

    Alere San Diego, Inc. is recalling 373 kits of the Alere Triage D-Dimer Test (Lot W53884B) because they may generate error codes or incorrect results.

    Product
    Alere Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage¿ Meters for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1746-2014·2014-06-18

    Philips IntelliVue MX40 Wearable Patient Monitor Alarm Failure Recall

    Philips is recalling IntelliVue MX40 monitors because alarms may not resume after being paused, potentially delaying clinical response.

    Product
    IntelliVue MX40 Wearable Patient Monitor in use with the Philips IntelliVue Information Center iX (PIIC iX); 865350, 865351, 865352
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1744-2014·2014-06-18

    BioDerm Skin Wipes Recalled for Potential Bacterial Contamination

    BioDerm, Inc. is voluntarily recalling specific skin wipes used in male incontinence devices due to potential bacterial contamination from a contract manufacturer.

    Product
    BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external, non-invasive and nonsterile device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1786-2014·2014-06-18

    Teleflex Recalls Taut Operative Cholangiogram Catheters Due to Missing Metal Support Tube

    Teleflex Medical is recalling 450 Taut Operative Cholangiogram Catheters because the metal support tube is missing. The recall covers units distributed in the US and Belgium.

    Product
    Taut Operative Cholangiogram Catheter, 4.5FR (1.5mm) x 76cm To facilitate the introduction of contrast media into the biliary ducts to obtain a cholangiogram during laparoscopic or open cholecystectomy.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-1742-2014·2014-06-18

    BioDerm Skin Wipes Recalled for Potential Bacterial Contamination

    BioDerm, Inc. is voluntarily recalling skin-prep wipes used with external male catheters due to potential bacterial contamination.

    Product
    BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an external…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1740-2014·2014-06-18

    Ivoclar Vivadent Recalls Bluephase Style Light Probes Due to Broken Glass Fibers

    Ivoclar Vivadent is recalling 241 Bluephase style light probes because a stock check revealed broken glass fibers between the connector and the fiber bundle.

    Product
    bluephase style Light probe Pin-point 6>2 mm black REF # 636 241. The accessory is a pin point light probe, an accessory to a dental curing light Ultraviolet activator for polymerization for use during dental curing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1730-2014·2014-06-18

    Maquet PowerLED 700 Surgical Light Recall Due to Detaching Module

    Maquet is recalling PowerLED 700 surgical lights because plastic tabs may break, causing the ambient light module to partially detach.

    Product
    Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1734-2014·2014-06-18

    Ortho-Clinical VITROS 4600 Chemistry System Recalled for Biased Results

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry Systems due to a potential for biased results when using Multiple Window codes.

    Product
    VITROS 4600 Chemistry System, Product Code/Catalog Number 6802445 for in vitro diagnostic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1725-2014·2014-06-18

    Leica Ceiling Mount MSF-1 Recalled Due to Broken Drive Screw

    Leica Microsystems is recalling 103 MSF-1 ceiling mounts because a broken drive screw caused the lift arm to fall approximately 60 cm.

    Product
    Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article Number 10446781 utilizes a supply voltage of 230 V. Article Number 10446782 utilizes a supply voltage of 110 V. Intended to be used for improving the visibility of objects through…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1726-2014·2014-06-18

    Leica Ceiling Mounts Recalled Due to Broken Drive Screw

    Leica Microsystems is recalling 103 ceiling mounts for M500 N microscopes because a broken drive screw caused the lift arm to fall approximately 60 cm.

    Product
    Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope. Article Number 10446657 utilizes a supply voltage of 110 V. Article Number 10446658 utilizes a supply voltage of 220 V. Intended to be used for improving the visibility of objects through…
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1782-2014·2014-06-18

    Cooper Surgical Tampa Catheter Recalled for Potential Sterility Compromise

    CooperSurgical is recalling 1,180 units of the Tampa Catheter because unsealed pouches may compromise the device's sterility.

    Product
    Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1743-2014·2014-06-18

    BioDerm Skin Wipes Recalled for Potential Bacterial Contamination

    BioDerm, Inc. is voluntarily recalling skin-prep wipes used with external male catheters due to potential bacterial contamination.

    Product
    BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protectant to the glands for control of male incontinence with an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1783-2014·2014-06-18

    Philips IntellVue Info Center Patient Monitor Recall for Reboot Loop

    Philips is recalling IntellVue Info Center monitors because a software defect causes reboot loops that interrupt patient monitoring.

    Product
    Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1765-2014·2014-06-18

    Stryker Recalls Zyphr Elite Round Fluted Bur Due to Missing Notches

    Stryker is recalling four sterile Zyphr Elite Round Fluted Burs because some units may have missing or partial notches, potentially affecting their use with Elite Attachments.

    Product
    Stryker 2.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1774-2014·2014-06-18

    Stryker Neuro Drill Accessories Recalled for Missing Notches

    Stryker is recalling 41 sterile neuro drill accessories due to missing or partial notches that may affect compatibility with Elite attachments.

    Product
    Stryker 2.5mm x 3.6mm Neuro Drill Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1755-2014·2014-06-18

    Stryker 5.5mm Round Fluted Bur Recall Due to Missing Notches

    Stryker is recalling 99 sterile 5.5mm Round Fluted Bur Soft Touch devices because some units may have missing or partial notches.

    Product
    Stryker 5.5mm Round Fluted Bur Soft Touch Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1764-2014·2014-06-18

    Stryker Recalls Zyphr Elite Round Fluted Bur Due to Missing Notches

    Stryker is recalling 107 sterile Zyphr Elite Round Fluted Burs because some units may have missing or partial notches, which could affect their use with Elite Attachments.

    Product
    Stryker 6.0mm Zyphr Elite Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical…
    Category
    Medical Device
    Distribution
    Distributed nationwide