🏥 Medical Devices Class I - Dangerous
Potential presence of elevated endotoxin levels that exceed the specification limit
All Recalls
95,114 total recalls in our database
The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.
🏥 Medical Devices Class I - Dangerous
Tungsten coils of the guidewire included in the introducer kit were detaching.
🏥 Medical Devices Class I - Dangerous
The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.
🏥 Medical Devices Class I - Dangerous
The analyzers fail on S7950 (Range +) QC measurements due to the hemolyzer cuvettes, a subcomponent of the optical system which measures ctHb and derivates. In a cuvette with light shunt, some of the received light has not been transmitted through the sample. This will lead to a perturbed and non-linear absorbance spectrum which results in measurement errors.
Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A, M3536A, and M3536M - Product Usage: is for use for the termination of ventricular tachycardia and ventricular fibrillation.
Philips North America
🏥 Medical Devices Class I - Dangerous
HeartStart XL MonitorlDefibrillators may not have been included in prior field actions and received required corrections
GENTLEWAVE REF: FG-002-0001
Sonendo
🏥 Medical Devices Class I - Dangerous
The console would continue to run for extended period when the foot pedal was released.
🏥 Medical Devices Class I - Dangerous
The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.
Cios Alpha Image-Intensified Fluoroscopic X-Ray System, Model Numbers VA20-10308191 and VA30-10308194 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
The unplugging of the main cable on the monitor trolley from the X10 connector can cause an unsafe electrical voltage (up to 67,6 V DC) at the X10 connector. This can result in an electrical shock if the user or other persons touch the contact pins of the X10 connector.
The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum delay of 2 seconds, instead of 40ms expected by design.
Potential presence of elevated endotoxin levels that exceed the specification limit
🏥 Medical Devices Class I - Dangerous
Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12, 12.1, or 12,2 are likely to experience a shortened transmitter battery life (approximately 4-5 days instead of the normal 7 days or more) after a full charge.
Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100
Cardinal Health
🏥 Medical Devices Class I - Dangerous
The feeding spike sets may leak at the interface of the tube and spike connector.
🏥 Medical Devices Class I - Dangerous
Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this problem Pajunk cannot guarantee the sterility of the affected batches.
Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
The Binding Site Group
🏥 Medical Devices Class I - Dangerous
Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to the reference material RF serum. This could result in reporting abnormal (false positive) results, which may lead to unnecessary additional serological testing and a delay in treatment.
The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum delay of 2 seconds, instead of 40ms expected by design.
The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. This problem can occur only when one of these Interface Modules is put off-line after a carrier in their secondary lane is physically returned on the main track and then put back on-line when the carrier is used to transport another tube.
🏥 Medical Devices Class I - Dangerous
The feeding spike sets may leak at the interface of the tube and spike connector.
🏥 Medical Devices Class I - Dangerous
The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.
🏥 Medical Devices Class I - Dangerous
Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this problem Pajunk cannot guarantee the sterility of the affected batches.