🏥 Medical Devices • 15,203 recalls
Medical Action Industries, Inc. 306
Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator.
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the right ventricular (RV) lead. No other device features or therapies are impacted.
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.
Incorrect size printed on the device; packaging is labeled correctly.
Merits Holdings Co.
Seat baseplate pin has broken in the field.
Merits Holdings Co.
Seat baseplate pin has broken in the field.
Nextremity Solutions
Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended
CHANGE HEALTHCARE CANADA COMPANY
Change Healthcare has identified an intermittent software defect which may result in an anchor study failing to display.
Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34.
Siemens Medical Solutions USA
Some Artis zee ceiling systems show an increased abrasion of the cabling at the cable outlet of the inner C-arm, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.
There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).
Potential for pinholes (sterile barrier breach) on the edge of the pouch to potentially render the device non-sterile, and may result in a post-operative infection
Boston Scientific
May have been programmed with a less than optimal brightness setting resulting in a darker than desired image
Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended
Mislabeled box contained a 6mm x 20mm screw instead of 6mm x 30mm screw
There are cybersecurity vulnerabilities in a widely used low-level TCP/IP software library that may result in a loss of communication to the Hospital Information System/Clinical Information System (HIS/CIS).
Smiths Medical ASD
The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.