ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A; eye surgery
Sklar Instruments
Reports of various packaging issues that may result in a breach of the sterile barrier.
92,900 total recalls in our database
Sklar Instruments
Reports of various packaging issues that may result in a breach of the sterile barrier.
Augustine Temperature Management
HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 may experience a Power-on self-test error code "EA POST".
Sklar Instruments
Reports of various packaging issues that may result in a breach of the sterile barrier.
Reports of various packaging issues that may result in a breach of the sterile barrier.
Trokamed GmbH
If the inflow speed is too quick, it could result in reduced outflow through the shaft due to blood, tissue fragments and kidney stone fragments, and quickly build up of intrarenal pressure.
Reports of various packaging issues that may result in a breach of the sterile barrier.
Baxter Healthcare
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
Intuitive Surgical
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
Boston Scientific
A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Intuitive Surgical
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.
Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.
Intuitive Surgical
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Intuitive Surgical
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Ostomy skin barrier package contains a pre-cut wafer of 28mm instead of 16mm and/or 35mm pre-cut wafers, as stated package labeling. If pre-cut wafers are too big the device cannot be used and if the pre-cut wafer is too small and the device user tries to apply, this could cause abrasion, stomal cut, and bleeding
Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.