BEUDAMED
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    Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-I

    FDA Recall
    Completed ·Applied Medical Technology Inc·Product code KNT·October 6, 2025

    Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05055-N-I

    FDA Recall
    Completed ·Applied Medical Technology Inc·Product code KNT·October 6, 2025

    Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06090-I

    FDA Recall
    Completed ·Applied Medical Technology Inc·Product code KNT·October 6, 2025

    Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 90 Nasal Feeding Tube with Stylet and ENfit, REF NFT-05090-I

    FDA Recall
    Completed ·Applied Medical Technology Inc·Product code KNT·October 6, 2025

    Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tube with Stylet and ENfit, REF NFT-06055-I

    FDA Recall
    Completed ·Applied Medical Technology Inc·Product code KNT·October 6, 2025

    Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7'' x 10.7'' Code: 0010206

    FDA Recall
    Completed ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·December 22, 2005

    Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 7.7'' x 9.7'' (19.6cm x 24.6cm) Code: 0010208

    FDA Recall
    Completed ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·December 22, 2005

    Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 10.8'' x 13.7'' (25.4cm x 33cm) Code: 0010207

    FDA Recall
    Completed ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·December 22, 2005

    Bard Composix Kugel Oval, 6.3'' x 12.3'' for hernia repairs Product Code: 0010209

    FDA Recall
    Completed ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·December 22, 2005

    Bard Composix Kugel Large Circle, 4.5'' for hernia repairs Product Code: 0010204

    FDA Recall
    Completed ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·December 22, 2005

    Bard Composix Kugel Large Oval, 5.4'' x 7'' for hernia repairs Product Code: 0010202

    FDA Recall
    Completed ·Davol, Inc., Sub. C. R. Bard, Inc.·Product code FTL·December 22, 2005

    Ceiling Mounted Surgical Light System TruLight 3000/5000 and Ceiling Mounted Surgical Light System iLED3/iLED5

    FDA Recall
    Completed ·Trumpf Medical Systems, Inc.·Product code FSY·November 2, 2015

    A1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device (the monitor), (2) a plastic cartridge enclosing dry reagent strips, and (3) a sample dilution kit for: collecting the blood sample, mixing the sample with the required pre-treatment solution, and delivering the sample to the cartridge.

    FDA Recall
    Completed ·Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc.·Product code LCP·September 18, 2024

    Fukuda Denshi patient monitor model DS-8100M and DS-8100N Product Usage: Use of the Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is indicated in those situations where observation of one or more of the following parameters on an individual patient may be required. ECG (waveform, heart rate, ST-Level and ventricular arrhythmias), respiration, non-invasive blood pressure (NIBP), pulse rate, arterial oxygen saturation (SpO2), carboxyhemoglobin saturation (SpCO)*, methemoglobin saturation (SpMet)*, total hemoglobin concentration (SpHb)*, plethysmograph, temperature, invasive blood pressure (IBP), cardiac output, and carbon dioxide concentration (CO2). *: DS-8100M only The target populations of the system are adult, pediatric and neonatal patients with the exception of the ST segment, arrhythmia analysis, and SpHb, for which the target populations are adult and pediatric excluding neonates. These observations can include an audible and visual alarm if any of these parameters exceed values that are established by the clinician. The observations may include the individual or comparative trending of one or more of these parameters over a period of up to 24 hours. The DS-8100N/8100M Patient Monitor is indicated in situations where an instantaneous display of waveform, numeric and trended values is desired. The DS-8100N/8100M Patient Monitor is also indicated where a hard copy record of the physiological parameters, the alarms conditions or the trended values may be required.

    FDA Recall
    Completed ·Fukuda Denshi Co., Ltd. 2-35-8 Hongo, Bunkyo-Ku Tokyo Japan·Product code MHX·October 16, 2017

    POWERPORT CLEARVUE isp, 6F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE isp, 8F CHRONOFLEX Catheter, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 6F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; POWERPORT CLEARVUE Slim, 8F CHRONOFLEX Catheter and Suture Plugs, Intermediate NAUTILUS DELTA Kit; NAUTILUS DELTA Tip Confirmation System (Includes: Netbook with Pre-loaded Software, Patient Module, and ECG Cable) Product Usage: Is an implantable access device designed to provide repeated access to the vascular system.

    FDA Recall
    Completed ·Bard Peripheral Vascular Inc·Product code LJT·June 25, 2018

    Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).

    FDA Recall
    Completed ·Mako Surgical Corporation·Product code OLO·October 23, 2020