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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28901–28925 of 40357

  • LowFDA (Devices)·Z-2918-2016·2016-10-12

    Arthrex Suture Washer Recalled Due to Incorrect Assembly

    Arthrex, Inc. is recalling 45 Suture Washers because the suture and washer were not assembled and were placed loose in the package.

    Product
    Arthrex Suture Washer
    Category
    Medical Device
    Distribution
    9 states
  • CriticalFDA (Devices)·Z-2783-2016·2016-10-05

    Anspach Effort Recalls Light Adaptors for Small Battery Drive Devices

    The Anspach Effort, Inc. is recalling Light Adaptors for Small Battery Drive and Small Battery Drive II devices due to a potential risk of bursting from excessive internal pressure.

    Product
    Light Adaptor for Small Battery Drive and Small Battery Drive II.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2883-2016·2016-10-05

    Trividia TRUEread Blood Glucose Test Strips Recalled for Incorrect Low Readings

    Trividia Health is recalling TRUEread Blood Glucose Test Strips because they may provide incorrect low blood glucose levels.

    Product
    TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2880-2016·2016-10-05

    Trividia Health Recalls TRUEread Blood Glucose Test Strips for Incorrect Readings

    Trividia Health is recalling TRUEread Blood Glucose Test Strips because they may provide incorrect low blood glucose levels, potentially affecting patient safety.

    Product
    TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2784-2016·2016-10-05

    Anspach Effort Recalls Small Battery Drive Adaptors Due to Burst Risk

    The Anspach Effort, Inc. is recalling 1,833 Small Battery Drive adaptors worldwide because they may generate excessive internal pressure and burst.

    Product
    Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in traumatology and orthopedic surgery of the skeleton, i.e. drilling, reaming or cutting bone. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2896-2016·2016-10-05

    Zyno Medical Administration Set Recalled for Potential Filter Leaking

    Zyno Medical LLC is recalling 47,989 sterile administration sets due to a potential filter leaking defect. The sets are used to administer fluids to patients.

    Product
    Zyno Medical Administration Set Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70072-F Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a needle…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2882-2016·2016-10-05

    Trividia Health Recalls TRUEread Blood Glucose Test Strips for Inaccurate Readings

    Trividia Health is recalling TRUEread Blood Glucose Test Strips because they may provide incorrect low blood glucose levels. The recall affects strips and kits distributed in the US and internationally.

    Product
    TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2886-2016·2016-10-05

    Spacelabs Xhibit Telemetry Receiver Recall for System Lockups

    Spacelabs Healthcare is recalling Xhibit Telemetry Receivers because the system may go offline or lock up, potentially failing to display alarms.

    Product
    Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2877-2016·2016-10-05

    Siemens PRIMUS Linear Accelerators Recalled for Software Safety Issues

    Siemens Medical Solutions is recalling 103 PRIMUS linear accelerators to install a software patch addressing several safety issues.

    Product
    PRIMUS, Accelerator, Linear, Medical The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2895-2016·2016-10-05

    Zyno Medical Administration Set Recalled for Potential Filter Leaking

    Zyno Medical LLC is recalling 78,063 sterile administration sets due to a potential filter leaking defect. The sets are distributed nationwide for use with infusion pumps or gravity feed.

    Product
    Zyno Medical Administration Set, Sterile. RX For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: B2-70071-DF Product Code: B2-70071-DF-120 (expanded recall) Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2888-2016·2016-10-05

    Spiegelberg Brain Pressure Monitoring Probes Recalled for Measurement Errors

    Spiegelberg is recalling 22 Brain Pressure Monitoring System probes due to air chamber shrinkage that caused false high readings in the lower measuring range.

    Product
    Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2881-2016·2016-10-05

    Trividia Health Recalls TRUEread Blood Glucose Test Strips for Inaccurate Readings

    Trividia Health is recalling TRUEread Blood Glucose Test Strips because they may provide incorrect low blood glucose levels.

    Product
    TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters. Quantitatively measure whole blood glucose in a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2893-2016·2016-10-05

    Zyno Medical Administration Set Recalled for Potential Filter Leaking

    Zyno Medical LLC is recalling 114,081 sterile administration sets due to a potential filter leaking defect. The sets are used to administer fluids to patients' vascular systems.

    Product
    Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80071-DF Product Code: A2-80071-DF-120 (Expanded recall) Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2885-2016·2016-10-05

    Spacelabs Xhibit Central Station Recalled for System Lockups and Alarm Failures

    Spacelabs Healthcare is recalling Xhibit Central Stations because the telemetry system may go offline, lock up, or fail to display audio and visual alarms for asystole.

    Product
    Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2894-2016·2016-10-05

    Zyno Medical Administration Set Recalled for Potential Filter Leaking

    Zyno Medical LLC is recalling 78,069 sterile administration sets because the filter may leak. The sets are used to administer fluids to patients.

    Product
    Zyno Medical Administration Set, Sterile. Rx For Use with Zyno Medical Infusion Pumps or Gravity Feed Product Code: A2-80072-F Product Usage: Zyno Medical Administration Set is a device used to administer fluids from a container to a patients vascular system through a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2878-2016·2016-10-05

    Siemens Syngo RT Therapist Software Recalled for Safety Issues

    Siemens Medical Solutions is recalling Syngo RT Therapist software to address several safety issues. The recall affects 103 linear accelerators nationwide.

    Product
    Syngo RT Therapist, Accelerator, Linear, Medical Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2876-2016·2016-10-05

    Siemens ARTISTE Linear Accelerators Recalled for Software Safety Issues

    Siemens Medical Solutions is recalling 103 ARTISTE linear accelerators to install a software patch addressing several safety issues.

    Product
    ARTISTE, Accelerator, Linear, Medical The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2879-2016·2016-10-05

    CareFusion Recalls Alaris Syringe Modules Due to Software Anomaly

    CareFusion 303, Inc. is recalling Alaris Syringe Module Model 8110 units with software version 9.15 because a software anomaly may cause infusions to stop unexpectedly.

    Product
    Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2892-2016·2016-10-05

    Siemens Medical Solutions Recalls Syngo.plaza VB10A Picture Archiving Systems

    Siemens Medical Solutions USA, Inc. is recalling 47 Syngo.plaza VB10A Picture Archiving and Communication Systems to eliminate several software issues.

    Product
    Syngo.plaza VB10A, Picture Archiving and Communication System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2891-2016·2016-10-05

    Siemens Syngo.plaza PACS Software Recall for Multiple Issues

    Siemens Medical Solutions is recalling 47 Syngo.plaza Picture Archiving and Communication System units to address several software issues.

    Product
    Syngo.plaza, Picture Archiving and Communication System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2884-2016·2016-10-05

    Microgenics Recalls DRI Salicylate Serum Tox Assay Due to Sensitivity Issues

    Microgenics Corporation is recalling specific lots of DRI Salicylate Serum Tox Assay kits because negative patient samples are recovering higher than the product's sensitivity claim.

    Product
    DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2900-2016·2016-10-05

    Beckman Coulter Recalls AQUIOS CL Flow Cytometers Due to Carousel Misalignment

    Beckman Coulter is recalling AQUIOS CL Flow Cytometers because the reagent carousel can misalign and damage the prep probe.

    Product
    AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2898-2016·2016-10-05

    Medtronic Recalls CareLink iPro Software Due to Time Stamp Error

    Medtronic is recalling CareLink iPro Version 1.10 software due to a time stamp error. The recall affects 33 units distributed nationwide.

    Product
    CareLink iPro Version 1.10, Catalog No. MMT-7340 With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2890-2016·2016-10-05

    EKOS Corporation Recalls EKOS Carts Due to Missing Wheel Washers

    EKOS Corporation is recalling 455 EKOS carts because missing washers may cause wheels to wear or dislodge, leading to equipment failure.

    Product
    The EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic Control Unit. The cart is designed with three poles to hold infusion pumps and fluid bags, a tray on which the EkoSonic Control unit sits and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2899-2016·2016-10-05

    Siemens ADVIA Centaur Calibrator U Recalled for Analytical Sensitivity Failure

    Siemens is recalling ADVIA Centaur Calibrator U kits due to failure of analytical sensitivity and drift from internal standardization.

    Product
    Siemens ADVIA Centaur¿ Calibrator U, For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur"' systems: Myoglobin cTnl Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)
    Category
    Medical Device
    Distribution
    Distributed nationwide