🏥 Medical Devices Class I - Dangerous
Due to a potential open seal in the sterile barrier packaging.
All Recalls
92,900 total recalls in our database
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Integra LifeSciences Corp. (NeuroSciences)
🏥 Medical Devices Class I - Dangerous
Inadequate weld that can potentially cause the product to disassemble.
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
🏥 Medical Devices Class I - Dangerous
Due to a potential open seal in the sterile barrier packaging .
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Integra LifeSciences Corp. (NeuroSciences)
🏥 Medical Devices Class I - Dangerous
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Artix MT Thrombectomy Device, REF: 32-102
Inari Medical - Oak Canyon
🏥 Medical Devices Class I - Dangerous
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.
Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
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.
CADD Solis HSPCA Pump
Smiths Medical ASD
🏥 Medical Devices Class I - Dangerous
Pumps may experience Wireless Connection Modules intermittent connection alarms, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Washer Disinfector Aquadis 56; Model Number: 56M
Getinge Disinfection Ab
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
Due to a potential open seal in the sterile barrier packaging .
Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
SCIENCE & BIO MATERIALS
🏥 Medical Devices Class I - Dangerous
Vials of implant bone granules may contain less product then specified on labeling.
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Tornier S.A.S.
🏥 Medical Devices Class I - Dangerous
A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
Bausch & Lomb Surgical
🏥 Medical Devices Class I - Dangerous
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.
Washer Disinfector Aquadis 56; Model Number: 56A
Getinge Disinfection Ab
🏥 Medical Devices Class I - Dangerous
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.
🏥 Medical Devices Class I - Dangerous
Due to a potential open seal in the sterile barrier packaging.
Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
Galt Medical
🏥 Medical Devices Class I - Dangerous
Due to a potential open seal in the sterile barrier packaging.
CODMAN Disposable Perforator, 14mm. Cranial perforator.
Integra LifeSciences Corp. (NeuroSciences)
🏥 Medical Devices Class I - Dangerous
Inadequate weld that can potentially cause the product to disassemble.
🏥 Medical Devices Class I - Dangerous
Due to a potential open seal in the sterile barrier packaging.
🏥 Medical Devices Class I - Dangerous
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.