🏥 Medical Devices • 15,809 recalls
Stradis Healthcare
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Blister package had an unsealed edge compromising sterility.
DeRoyal Industries
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach.
Medtronic Navigation
Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.
CareFusion 303
Due to customer complaints related to the MedBank software which may indicate that a different medication is loaded in a cubie (drawer) pocket than what is physically loaded and listed on the pocket label. As a result of this issue, a patient could receive the wrong medication or wrong dose of medication that could lead to patient harm.
The Anspach Effort
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
All lots of BIOSTOP G Bioresorbable Cement Restrictor are being removed as a precautionary measure because tested endotoxin levels were higher than recommended by the current FDA regulatory guidance. In general, endotoxins have a potential to initiate inflammatory responses, ranging from a mild fever to potentially impact or damage to vital organs.
The Anspach Effort
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
Medtronic Neuromodulation
Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"
Stradis Healthcare
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Stradis Healthcare
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
As the temperature and time out of range was exceeded, product performances cannot be guaranteed