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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35401–35425 of 40449

  • HighFDA (Devices)·Z-2064-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 500 CTS Coagulation Instruments

    Instrumentation Laboratory is recalling ACL TOP 500 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 500 CTS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2045-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra Anchor XL Due to Sterility Breach

    Smith & Nephew is recalling 259 units of SUTUREFIX Ultra Anchor XL devices because a breach in the sterile barrier compromised the device's sterility.

    Product
    SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2028-2014·2014-07-23

    Terumo Sarns Centrifugal Pump Recalled for Pumphead Leaks

    Terumo is recalling Sarns Disposable Centrifugal Pumps because leaks were detected on the pumphead during set-up and priming.

    Product
    Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2048-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra S Suture Due to Sterility Breach

    Smith & Nephew is recalling SUTUREFIX Ultra S sutures because the sterile barrier is compromised, posing a risk of infection.

    Product
    SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2055-2014·2014-07-23

    Stryker Communications Recalls SHAPE Arm Brackets for Boom Systems

    Stryker Communications is recalling 953 SHAPE Arm brackets used in operating rooms because the monitor mount may detach if specific hardware is missing.

    Product
    BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as component of kit part number 0682000976, and the Arm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2053-2014·2014-07-23

    Stryker SHAPE Arm Dual SH2 Recalled for Potential Monitor Detachment

    Stryker Communications is recalling SHAPE Arm Dual SH2 brackets because the monitor mount may detach if specific hardware is missing.

    Product
    SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400254 and the Arm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2056-2014·2014-07-23

    Stryker Communications Recalls SHAPE Arm Brackets for Potential Monitor Detachment

    Stryker Communications is recalling 953 SHAPE Arm brackets because the monitor mount may detach if a lock washer and screw are missing.

    Product
    BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682000977, and the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2061-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 700 Coagulation Instruments

    Instrumentation Laboratory is recalling 633 ACL TOP 700 automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 700, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2063-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 700 LAS Coagulation Instruments

    Instrumentation Laboratory is recalling 99 ACL TOP 700 LAS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 700 LAS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2059-2014·2014-07-23

    Mindray V-Series Patient Monitoring System Recalled for ECG Interpretation Errors

    Mindray is recalling 113 V-Series Patient Monitoring Systems due to software issues causing false ECG measurements and incorrect interpretive statements.

    Product
    V-Series Patient Monitoring System, Manufactured for Mindray DS USA, Inc. Used for monitoring of human physiological parameters. The V-Series Monitor also has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2049-2014·2014-07-23

    Smith & Nephew Recalls SUTUREFIX Ultra S Sutures Due to Sterility Breach

    Smith & Nephew is recalling 763 units of SUTUREFIX Ultra S Double Loaded Sutures because the sterile barrier was breached, compromising the device's sterility.

    Product
    SUTUREFIX Ultra S Double Loaded Suture Product Code: 72203854 Fastener, fixation, nondegradable, soft tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 700 CTS Coagulation Instruments

    Instrumentation Laboratory is recalling 266 ACL TOP 700 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 700 CTS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2069-2014·2014-07-23

    Axcentria Recalls Calcium Hydroxide Powder Due to Missing 510(k) Approval

    Axcentria Pharmaceuticals is recalling one lot of Calcium Hydroxide Powder because it was distributed without FDA approval and lacks usage instructions.

    Product
    Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further…
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2043-2014·2014-07-23

    Siemens Symbia E Camera System Recalled for Loose Rear Casters

    Siemens Medical Solutions USA is recalling 531 Symbia E camera systems because the collimator cart rear casters may become loose.

    Product
    Symbia E camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. Nuclear…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2078-2014·2014-07-23

    Dental EZ Group Recalls 45 Mislabelled Titan T 5K Dental Motors

    Dental EZ Group is recalling 45 Titan T 5K dental motors because the housing was incorrectly laser marked as a 20K motor.

    Product
    Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of dental procedures including caries removal, finishing, polishing, pin setting and prophy.The motor has a speed range of 100 to 5000 rpm capability.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2077-2014·2014-07-23

    Spacelabs Ultraview SL Multigas Module Recalled for Invalid MAC Display

    Spacelabs Healthcare is recalling 8 Ultraview SL Multigas Modules because the software displays an invalid Minimum Alveolar Concentration value.

    Product
    Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2057-2014·2014-07-23

    Remel Inc. Recalls Thermo Scientific VersaTREK REDOX 1 In Vitro Diagnostic Product

    Remel Inc. is recalling specific lots of Thermo Scientific VersaTREK REDOX 1 in vitro diagnostic products because they failed to provide positive signals for Streptococcus pneumoniae.

    Product
    Thermo Scientific VersaTREK REDOX 1, Ref 7102-44, 80ml with Stir Bar (O2 aerobic), 50 bottles/box, IVD. The firm name on the label is Remel Inc., Lenexa, KS.
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-2073-2014·2014-07-23

    Laser Peripherals Recalls Mislabelled Bare Laser Fibers Due to Date Error

    Laser Peripherals LLC is recalling 25 units of DBLF-60-2 Bare Laser Fibers because a sterility expiration date was misprinted as '2016-16' instead of '2016-06'.

    Product
    LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in general and plastic surgery and in dermatology
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2050-2014·2014-07-23

    Zimmer Dental Tapered Screw-Vent Implant Recalled for Potential Vial Crack

    Zimmer, Inc. is voluntarily recalling a specific lot of dental implants due to a potential crack in the outer vial cap.

    Product
    Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2067-2014·2014-07-23

    Innovasis Recalls Excella II Pedicle Screws Due to Mislabeling

    Innovasis is recalling 32 units of Excella II Standard Pedicle Screws because the size and catalog number are mislabeled.

    Product
    Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2075-2014·2014-07-23

    Siemens syngo RT Dosimetrist 2.7 software update addresses data storage issue

    Siemens Medical Solutions is updating syngo RT Dosimetrist 2.7 software to fix a safety issue where structure names were not stored correctly.

    Product
    Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2072-2014·2014-07-23

    Integra Recalls Camino ICP Catheters for MRI Safety Labeling

    Integra LifeSciences is recalling Camino Intracranial Pressure Monitoring Kits to update labeling indicating they are unsafe in MR environments.

    Product
    Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2044-2014·2014-07-23

    MTI Precision Products Recalls Lynx TM20 Torquemaster Low Speed Handpieces

    MTI Precision Products LLC is recalling 134 Lynx TM20 Torquemaster Low Speed Handpieces due to a sharp edge on the body or housing.

    Product
    Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2071-2014·2014-07-23

    Siemens RAPIDComm Data Management System Recalled for Incorrect Test Names

    Siemens Healthcare Diagnostics Inc is recalling six RAPIDComm Data Management Systems because the 5.0 screen layout displays incorrect test names.

    Product
    Siemens RAPIDComm¿ Data Management System. The RAPIDComm¿ Data Management System manages the process of sending and receiving data from Siemens POC devices and hospital systems located in the hospital network,
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2042-2014·2014-07-23

    Siemens e.cam camera systems recalled for loose rear casters

    Siemens Medical Solutions USA is recalling 2,458 e.cam camera systems because the collimator cart rear casters may become loose.

    Product
    e.cam camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. Nuclear…
    Category
    Medical Device
    Distribution
    Distributed nationwide