May 21, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-0004A; 3) BT-80-0008; 4) BT-80-0008A;
Hazard: A cybersecurity vulnerability was discovered through internal testing.
May 21, 2025Medical DevicesFDA
Baxter Healthcare Corporation recalls Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2) BT-20-0002A; 3) BT-20-0002AP; 4) BT20
Hazard: A cybersecurity vulnerability was discovered through internal testing.
May 21, 2025Medical DevicesFDA
Vyaire Medical recalls Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH265 Software Version: N/
Hazard: Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.
May 21, 2025Medical DevicesFDA
Vyaire Medical recalls Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Number: AH165 Software Version: N/
Hazard: Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.
May 14, 2025Medical DevicesFDA
Philips Medical Systems Nederland B.V. recalls IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Hazard: An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
May 14, 2025Medical DevicesFDA
WANDERCRAFT SAS recalls Atalante X, Powered Exoskeleton. Atalante X is intended to perform ambulatory functions and mobility exercises, hands-
Hazard: Potential for exoskeleton to lose lateral balance and cause patient to fall.
May 14, 2025Medical DevicesFDA
Tornier S.A.S. recalls Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Hazard: A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
May 14, 2025Medical DevicesFDA
Galt Medical Corporation recalls Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers ar
Hazard: Due to a potential open seal in the sterile barrier packaging.
May 14, 2025Medical DevicesFDA
Galt Medical Corporation recalls Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
Hazard: Due to a potential open seal in the sterile barrier packaging.
May 14, 2025Medical DevicesFDA
Galt Medical Corporation recalls Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 0084126810480
Hazard: Due to a potential open seal in the sterile barrier packaging.
May 14, 2025Medical DevicesFDA
Galt Medical Corporation recalls GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position
Hazard: Due to a potential open seal in the sterile barrier packaging.
May 14, 2025Medical DevicesFDA
Galt Medical Corporation recalls B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV
Hazard: Due to a potential open seal in the sterile barrier packaging .
May 14, 2025Medical DevicesFDA
Galt Medical Corporation recalls B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introduce
Hazard: Due to a potential open seal in the sterile barrier packaging .
May 14, 2025Medical DevicesFDA
Galt Medical Corporation recalls GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations
Hazard: Due to a potential open seal in the sterile barrier packaging .
May 14, 2025Medical DevicesFDA
Remote Diagnostic Technologies Ltd. recalls Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
Hazard: Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot after intermittent connection with Smart Mount, 4) 12-lead ECG measurements with Louvain algorithm and software before vx.36 could produce inaccurate rhythm/morphology statements.
May 14, 2025Medical DevicesFDA
Inari Medical - Oak Canyon recalls Artix MT Thrombectomy Device, REF: 32-102
Hazard: Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the radial force on the artery, which has the potential of vascular complications.
May 14, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Hazard: Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
May 14, 2025Medical DevicesFDA
Ambu Inc. recalls Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Hazard: Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product inside correctly states 5.6/2.8.
May 14, 2025Medical DevicesFDA
Philips North America Llc recalls Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intub CO2 Line STerm , Adt/Pedi Intub
Hazard: Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
May 14, 2025Medical DevicesFDA
Getinge Disinfection Ab recalls Washer Disinfector Aquadis 56; Model Number: 56M
Hazard: The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.
May 14, 2025Medical DevicesFDA
Getinge Disinfection Ab recalls Washer Disinfector Aquadis 56; Model Number: 56A
Hazard: The frequency inverter is not programmed by supplier according to specification which causes the circulation pump to start earlier than expected, resulting in additional wear and tear, earlier than expected, on the axial seal in the pump housing.
May 14, 2025Medical DevicesFDA
MEDLINE INDUSTRIES, LP - Northfield recalls Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
Hazard: A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements.
May 14, 2025Medical DevicesFDA
SCIENCE & BIO MATERIALS recalls Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
Hazard: Vials of implant bone granules may contain less product then specified on labeling.
May 14, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Hazard: Inadequate weld that can potentially cause the product to disassemble.
May 14, 2025Medical DevicesFDA
Integra LifeSciences Corp. (NeuroSciences) recalls CODMAN Disposable Perforator, 14mm. Cranial perforator.
Hazard: Inadequate weld that can potentially cause the product to disassemble.
May 14, 2025Medical DevicesFDA
Smiths Medical ASD, Inc. recalls CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS VIP, MDL 2120, NA ENGLISH, MANUAL MODE, 1/EA
Hazard: There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
May 14, 2025Medical DevicesFDA
Smiths Medical ASD, Inc. recalls CADD-Solis Infusion Pump Models: 1) PUMP KIT, CADD-SOLIS, MDL 2110, V4.2, CE ENGLISH 1/EA, Model Number: 21-2111
Hazard: There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
May 14, 2025Medical DevicesFDA
Bausch & Lomb Surgical, Inc. recalls Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
Hazard: In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
May 14, 2025Medical DevicesFDA
Bausch & Lomb Surgical, Inc. recalls Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA;
Hazard: In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
May 14, 2025Medical DevicesFDA
Smiths Medical ASD, Inc. recalls CADD-Solis VIP Ambulatory Infusion Pump; Model/Number: 21-2120-0100-02 21-2120-0100-03 21-2120-0100-06 21-2120-0
Hazard: Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.