A potential for a light system to fall in the operating room.
All Recalls
95,018 total recalls in our database
A potential for a light system to fall in the operating room.
Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.
Getinge Usa Sales
🏥 Medical Devices Class I - Dangerous
A potential for a light system to fall in the operating room.
HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, List Number MX497HP
Smiths Medical Asd
🏥 Medical Devices Class I - Dangerous
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient).
A potential for a light system to fall in the operating room.
🏥 Medical Devices Class I - Dangerous
Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
Percussionaire
🏥 Medical Devices Class I - Dangerous
Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
(1) CareEvent, Model No. 866435 (2) CareEvent Upgrade, Model no. 866436
Philips North America
🏥 Medical Devices Class I - Dangerous
Push notifications may fail to send to the user under certain conditions. This could potentially result in patient harm due to delay in detection of a change in patient condition.
Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection
Maquet Cardiovascular
🏥 Medical Devices Class I - Dangerous
Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.
A potential for a light system to fall in the operating room.
🏥 Medical Devices Class I - Dangerous
Backrest platform stress fracture - the table is not operational in an inclined position
🏥 Medical Devices Class I - Dangerous
Backrest platform stress fracture - the table is not operational in an inclined position
6IN PRESSURE TUBING, List Number MX20617
Smiths Medical Asd
🏥 Medical Devices Class I - Dangerous
There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.
Vasoview Hemopro Endoscopic Vessel Harvesting System, model VH-3500.
Maquet Cardiovascular
🏥 Medical Devices Class I - Dangerous
Risk of polyimide particulate matter being present on the endoscopic harvesting vessel system. This issue may result in polyimide particulate matter being introduced into the arterial conduit for patients undergoing a coronary artery bypass graft (CABG) or peripheral bypass graft surgery.
🏥 Medical Devices Class I - Dangerous
A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement.
🏥 Medical Devices Class I - Dangerous
Wrong structures imported into the GammaPod Treatment Planning System.-system allowed an RTSS generated from a previous CT scan to be selected
Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its original position.
🏥 Medical Devices Class I - Dangerous
It was determined that the Endotracheal Tube Holder included in certain kits is not compatible with a cricothyrotomy procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.
INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
PHASE SCIENTIFIC INTERNATIONAL LIMITED
🏥 Medical Devices Class I - Dangerous
COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when the correct expiration should be 21 February 2024. Expired tests could produce invalid or inaccurate results.