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ICU Medical's LifeShield Drug Library Management software version 2.2.1 has a problem where the Change Summary review tool stops working correctly after a library migration. This affects only customers who upgraded from version 2.1x and use Plum Duo v1.1 infusion pumps. When the review tool doesn't work, staff may not catch errors in pump settings.

Moderate·FDA·Dec 31, 2025

A faulty motor connector in certain da Vinci 5 surgical systems may cause Error 23062, which locks the surgeon console's ergonomic adjustments (viewer, headrest, armrest, and pedal position). This could delay or disrupt a scheduled surgical procedure. The issue affects 144 systems across 30 states.

Moderate·FDA·Dec 31, 2025

The Stryker CranialMask Tracker, a surgical tracking device used during head and neck procedures, can display a software error message when activated in the operating room, making it unusable. This affects 320 units worldwide across specific lot numbers. No injuries have been reported.

Moderate·FDA·Dec 31, 2025

BD Pyxis automated medication dispensing cabinets used in hospitals and pharmacies received a firmware update that caused certain drawers to fail. When a drawer fails, staff may have difficulty accessing or restocking medications, which could delay patient care.

Moderate·FDA·Dec 31, 2025

Alcon Custom Pak sterile surgical procedure packs used in eye surgery may have incomplete seals that could compromise sterility. This affects 151 units across specific lot numbers. No injuries have been reported.

Serious·FDA·Dec 31, 2025

Draeger, Inc. is recalling certain Vapor 2000 anesthetic vaporizers because an internal component was manufactured with impurities and did not meet quality specifications. The affected units are identified by specific serial numbers and were distributed worldwide, including across the United States.

Serious·FDA·Dec 31, 20252 products

AGFA's DR 800 digital X-ray system can deliver higher radiation doses than the FDA allows during certain fluoroscopy procedures. This happens when the frame rate is increased on the NX workstation without proper safety features enabled. About 35 systems are affected nationwide.

Moderate·FDA·Dec 31, 2025·Agfa

A New Life Herbs is recalling nine herbal supplement products sold as alcohol tincture, capsule, and dropper-bottle products, including products for immune, pain, sinus, and baby-care use. The FDA says the labels make unapproved drug claims and the products lack a Supplement Facts label. The products were distributed in AL, AZ, CA, GA, IL, IN, MN, MO, MS, NC, NY, and TN, and no injuries have been reported.

Moderate·FDA·Dec 31, 2025·A New Life Herbs9 products

Merck is recalling two prescription medicines, Emend (aprepitant) for oral suspension 125 mg single-dose kits and Noxafil Powdermix (posaconazole) 300 mg packets, because they may contain metal particles. The recall covers 3 Emend kits and 845 Noxafil Powdermix kits, distributed nationwide. No injuries have been reported.

Moderate·FDA·Dec 31, 2025·Merck2 products

Abbott Laboratories is recalling certain Alinity ci-series System Control Modules with software version 3.6.1 or lower due to a performance issue that could produce inaccurate lab test results. The issue affects multiple analytes and was discovered during Abbott's internal testing.

Serious·FDA·Dec 24, 2025

Cepheid is recalling two Xpert BCR-ABL Ultra in vitro diagnostic test kits, 10,357 units in total. Specimens with a white blood cell count above 30,000 cells may produce inaccurate test results. No injuries have been reported.

Moderate·FDA·Dec 24, 20252 products

Medtronic MiniMed InPen App users on Android (versions 7.5.0, 7.5.1, and 8.0.0) may lose insulin reminders if they uninstall and reinstall the app. The notification settings screen doesn't appear during setup, preventing notifications from overriding your phone's mute or Do Not Disturb mode. This could delay insulin therapy.

Moderate·FDA·Dec 24, 2025

Smith & Nephew is recalling certain BIOSURE HA Screws (6mm x 20mm bone fixation screws) due to a labeling error on affected units. The screws themselves are safe, but the packaging labels on a small number of units contain incorrect information. No injuries have been reported.

Moderate·FDA·Dec 24, 2025·Smith & Nephew

Rocket Medical is recalling six Seldinger catheter chest tube kits in two sizes each, totaling about 2,700 affected units. The instructions and kit labeling contain misleading statements that could lead to the device not being secured properly, so it may fall out during use. No injuries have been reported.

Moderate·FDA·Dec 24, 2025·Rocket Medical6 products

DSAART is recalling six AART silicone implant products, covering about 594 implants in total. The implants were made outside the company's specifications and were distributed without the FDA premarket approval or clearance required for them. No injuries have been reported.

Moderate·FDA·Dec 24, 2025·DSAART6 products

Intelerad InteleShare medical imaging software versions 3.24.3 through 3.25.2 contain a bug that can produce inaccurate measurement values when certain viewing features are used together. This could lead to incorrect measurements on medical images, potentially affecting diagnosis and treatment planning.

Moderate·FDA·Dec 24, 2025·DICOM Grid

A speaker component change in certain PATH Madsen Accuscreen DPOAE probes can cause technical distortions that mimic real hearing responses. This may result in incorrect "PASS" outcomes on infant hearing screening tests when a baby should have failed. The issue occurs when high stimulus levels combine with the device's sensitivity settings.

Serious·FDA·Dec 24, 2025·PATH

Instrumentation Laboratory recalled specific lots of HemosIL SynthAFax Partial Thromboplastin Time tests because they were manufactured with twice the intended amount of preservative. This could affect test accuracy. No injuries have been reported.

Moderate·FDA·Dec 24, 2025

The instruction guide for SeaSpine's NorthStar OCT Navigation surgical instruments incorrectly states that the tools work with both Medtronic Solera and Infinity system toolcards. In fact, they only work with Solera toolcards. Using these instruments with an Infinity system toolcard could result in device malfunction during surgery.

Moderate·FDA·Dec 24, 2025

Fresenius Medical Care identified several software problems in the 5008X CAREsystem +CLiC +CDX dialysis machine that could interfere with patient treatment. One anomaly could potentially cause the machine to stop treatment if certain conditions occur. This affects 115 units with software versions older than 4.82.4.

Serious·FDA·Dec 24, 2025

GE HealthCare ViewPoint 6 versions 6.15.3 and 6.15.4 may not display complete patient medical history information in the Patient History tab. This affects specific ultrasound systems used in medical facilities. No injuries have been reported.

Moderate·FDA·Dec 24, 2025

Datascope is recalling two Cardiosave devices, Cardiosave Hybrid and Cardiosave Rescue, which are included in this recall for about 11,517 units. The recall was issued because an instructions-for-use addendum updated the Vibration and Shock Table to reference the correct standards. No injuries have been reported.

FDA·Dec 24, 20252 products

AVID Medical is recalling five Halyard procedure packs because the header bag may not be fully sealed. The recall includes 728 units distributed in Georgia, Illinois, Nebraska, and Maryland. No injuries have been reported.

Moderate·FDA·Dec 24, 20255 products

Zimmer Biomet is recalling two surgical skin-graft tools, the Zimmer Air Dermatome and the Zimmer Dermatome AN, because the thickness control bar may be misaligned. The recall covers 1,337 units (839 Air Dermatomes and 498 AN Dermatomes) distributed across many countries, including the USA. No injuries have been reported.

Moderate·FDA·Dec 24, 20252 products

Medline is recalling 2 sterile surgical products, sold nationwide and distributed in CA, CO, IL, KS, and MI, because their packaging seals may be weak. If a seal fails, sterility may be lost, which could raise the risk of infection if the product is used. No injuries have been reported.

Moderate·FDA·Dec 24, 20252 products

Mindray's BeneVision Distributed Monitoring System (DMS) workstations with specific hardware and audio driver configurations may experience audio playback failure or screen freezing during operation. This can affect the usability of the central monitoring system in clinical settings. About 906 units are affected worldwide.

Moderate·FDA·Dec 24, 2025

GE Healthcare is recalling certain Carestation 600 and 700 Series anesthesia systems, along with a related power management board part, because they may unexpectedly shut down if AC power is unplugged or lost. These systems have no continuous backup power and do not automatically switch to battery, so they reboot and may briefly interrupt ventilation and anesthetic delivery without returning to previous settings. The recall covers 3 product entries with about 2,368 units affected, and no injuries have been reported.

Serious·FDA·Dec 24, 20253 products

Fresenius Kabi has recalled software version 5.10.1 and earlier for the Ivenix Infusion System due to anomalies that could cause serious patient harm. The affected software is used to control the delivery of fluids to patients in medical settings. About 30 units have been distributed across multiple U.S. states.

Serious·FDA·Dec 24, 2025

Celebration Herbals Senna Leaf Herbal Tea (24 teabags, 1.48 oz) may be contaminated with Salmonella. The affected product has lot code 251004 with a best-by date of October 29, 2028. No illnesses have been reported.

Moderate·FDA·Dec 24, 2025

The Whole Herb Company is recalling senna leaves (Item No. SEN15001, Lot No. 003279ST) because they may be contaminated with Salmonella. The recall affects approximately 3,580 pounds of product distributed in California, New Jersey, and Canada.

Serious·FDA·Dec 24, 2025