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Showing 741–760 of 1734 results

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STA-Liquid Anti-Xa 8 (Diagnostica Stago) – Contamination Risk (2025)

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

FDAJul 21, 2025Nationwide• Diagnostica Stago, Inc.

STA-Fibrinogen 5 (Diagnostica Stago) – Contamination Risk (2025)

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

FDAJul 21, 2025Nationwide• Diagnostica Stago, Inc.

Altivate Reverse Wedge Reamer (DJO Surgical) – Kickback Risk (2025)

Their is a potential that the reamer may kick or bind up during or immediately prior to use.

Moderate

FDAJul 18, 2025Nationwide

Orthopedic Pack (O&M Halyard) – Sterility Compromise (2025)

Surgical drape packs may have open seals, which may compromise the sterility of the product.

FDAJul 17, 2025Nationwide• O & M HALYARD INC

IPC Powerease System (Medtronic) – Driver Wobble Issue (2025)

Due to out of the box wobble of the driver.

FDAJul 17, 2025AZ, CA, CO +22 more• Medtronic Xomed, Inc.

Pinnacle 3 TumorLOC (Philips) – Calculation Error (2025)

Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,

FDAJul 17, 2025Nationwide• Philips Medical Systems (Cleveland) Inc

SureStep Foley Tray System (Bard) – Labeling Inaccuracy (2025)

Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction

FDAJul 17, 2025Nationwide• C.R. Bard Inc

ReQuest Measles IgM Test (Quest) – FDA Approval Missing (2025)

Measles IgM Test Kit lacks premarket approval or clearance.

FDAJul 17, 2025Nationwide• Quest International, Inc.

SureStep Foley Tray System (Bard) – Labeling Inaccuracy (2025)

Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction

FDAJul 17, 2025Nationwide• C.R. Bard Inc

TOPS Inserter (Premia Spine) – Missing Pin Risk (2025)

Potential for missing pins at tip of inserter.

FDAJul 16, 2025Nationwide• PREMIA SPINE LTD Giborey Israel 7 Ramat Poleg Netanya Israel

Dynex Agility Sample Tips (Dynex) – Labeling Error (2025)

The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. When scanned by the Agility instrument, the tip rack is misidentified as a different tip type, rendering it incompatible with the system and preventing use which causes a delay in obtaining patient results.

FDAJul 16, 2025CA, FL, NJ +2 more• Dynex Technologies, Inc.

Pentax Medical Video Processor (Pentax) – Image Discoloration (2025)

During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. Users have observed smoke like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient and may cause thermal injury to the patient s mucous membrane.

FDAJul 16, 2025AZ, CA, FL +17 more• Pentax of America Inc

Plastic Trial Head (Waldemar Link) – Labeling Inconsistency (2025)

Inconsistent size terminology and color coding used on labeling

FDAJul 15, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Chromophare Surgical Light (Stryker) – Coating Stress Lines (2025)

Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.

FDAJul 15, 2025Nationwide• Stryker Communications

Prosthesis Head B (Waldemar Link) – Labeling Inconsistency (2025)

Inconsistent size terminology and color coding used on labeling

FDAJul 15, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Baxter Novum IQ Pump (Baxter) – Infusion Transition Risk (2025)

Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level of underinfusion is variable based on the current infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer the duration the pump has been running at the current infusion rate and the larger the magnitude of the rate change, the larger the underinfusion that would be experienced. Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions for use, customers should ensure that: 1) The door is fully open before loading the set. 2) The tubing is taut and loaded without slack in the pumping channel.

FDAJul 14, 2025Nationwide• Baxter Healthcare Corporation

American Contract Systems Kits (ACS) – Sterilization Concern (2025)

During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

FDAJul 14, 2025IL, LA• American Contract Systems Inc

Spectrum IQ Infusion Pump (Baxter) – Grease Breakdown (2025)

Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.

FDAJul 14, 2025AZ, FL• Baxter Healthcare Corporation

3mensio Workstation (PIE Medical) – Measurement Error (2025)

When fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position which may cause stent graft fenestrations at incorrect position, which may lead to blood flow disruption and tissue damage

FDAJul 14, 2025Nationwide• PIE Medical Imaging B.V. Demertdwarsstraat 8A01 Maastricht Netherlands

Corin Operating Tables (Maquet) – Device Interference Risk (2025)

Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could prevent the device from performing as intended. If the issue occurs, the operating table is unresponsive to command from both the universal remote control and override panel.

FDAJul 14, 2025Nationwide• MAQUET GMBH Kehler Str. 31 Rastatt Germany

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