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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
The battery for certain ultrasound systems can potentially develop an internal failure which could result in smoke or fire.
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
Due to incorrect the battery charger being packaged and distributed. Product labeling does not match the intended product as specified.
Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
product mix-up; Vascular stent labeled as one size but contains a different size.
Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the cartridge holder; or the cartridge holder may be difficult to remove from the insulin pen. If the issue is present, and if the user does not have backup insulin they may experience temporary hyperglycemia.
product mix-up; Vascular stent labeled as one size but contains a different size.
The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use.
There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compressions due to code FC1060.
A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)
Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. A gasket failure could lead to potential fluid ingress due to cleaning, or as a result of an IV fluid spill.
Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
During some clinical cases, it has been observed that the SO2 value may periodically appear as dashes on the Touchscreen Display indicating unavailable data. In these cases, a yellow low-limit alarm will also be triggered to the user, due to the dashed-out value.