February 25, 2026Medical DevicesFDA
Medica Corporation recalls Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.
Hazard: A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.
February 25, 2026Medical DevicesFDA
Immunotech A.S. recalls Estrone RIA, REF: DSL8700
Hazard: The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur.
February 25, 2026Medical DevicesFDA
Baxter Healthcare Corporation recalls Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Desc
Hazard: Pumps were released without full testing being performed, including occlusion alarm testing.
February 25, 2026Medical DevicesFDA
Bard Peripheral Vascular Inc recalls Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060
Hazard: Due to damage to outer tray that can potentially compromise the sterile barrier
February 25, 2026Medical DevicesFDA
Medline Industries, LP recalls Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYN
Hazard: Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication.
February 25, 2026Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conduc
Hazard: Potential packaging failures, which could lead to a breach in the sterile barrier.
February 25, 2026Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1) 31012, (2) 31022, (3) 31045. MEDIHONE
Hazard: Potential packaging failures, which could lead to a breach in the sterile barrier.
February 25, 2026Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 31805, (2) 31815. MediHoney Gel dressing wit
Hazard: Potential packaging failures, which could lead to a breach in the sterile barrier.
February 25, 2026Medical DevicesFDA
Wilson-Cook Medical Inc. recalls Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA
Hazard: Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.
February 25, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automat
Hazard: Issue with software algorithm which may lead to overpressure events.
February 25, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automa
Hazard: Issue with software algorithm which may lead to overpressure events.
February 25, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic
Hazard: Issue with software algorithm which may lead to overpressure events.
February 18, 2026Medical DevicesFDA
Steris Corporation recalls Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
Hazard: This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.
February 18, 2026Medical DevicesFDA
SUREPULSE MEDICAL LTD recalls Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
Hazard: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
February 18, 2026Medical DevicesFDA
SUREPULSE MEDICAL LTD recalls Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
Hazard: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
February 18, 2026Medical DevicesFDA
SUREPULSE MEDICAL LTD recalls Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
Hazard: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
February 18, 2026Medical DevicesFDA
SUREPULSE MEDICAL LTD recalls Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
Hazard: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
February 18, 2026Medical DevicesFDA
SUREPULSE MEDICAL LTD recalls Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
Hazard: Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.
February 18, 2026Medical DevicesFDA
Intuitive Surgical, Inc. recalls da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number: 380730-45
Hazard: Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field (depth perception) but 2D maintained, or loss of both displays-complete visualization loss, without fault, instruments remain active, could lead to instrument contact with tissue, resulting in injury/bleeding; may require alternate surgical modality.
February 18, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions:
Hazard: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
February 18, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
Hazard: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
February 18, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - Al
Hazard: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
February 18, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 M12 System Model Numbers: (1)722078, (2)722223, (3)722233; Software Version Number - All versions: R1.X, R2.
Hazard: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
February 18, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.
Hazard: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
February 18, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R
Hazard: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
February 18, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number -
Hazard: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
February 18, 2026Medical DevicesFDA
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X,
Hazard: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
February 18, 2026Medical DevicesFDA
Alphatec Spine, Inc. recalls ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471;
Hazard: Due a design issue where the navigated array connection geometry is incorrect.
February 18, 2026Medical DevicesFDA
Alphatec Spine, Inc. recalls ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179;
Hazard: Due a design issue where the navigated array connection geometry is incorrect.
February 18, 2026Medical DevicesFDA
Laerdal Medical Corporation recalls Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU
Hazard: units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.