All Recalls

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"

There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.

Complaints of leaking packets were received.

Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"

Integra LifeSciences identified that one lot was released with out-of-specification endotoxin results. The worst-case risk for the use of affected Surgical Patties is potentially a minor transient fever.

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

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Software anomalies, CP App messages: "Too Many Device Found", "Unexpected Device Error Code 1502", and "System Update Needed, Service Code 303"

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

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 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.

Defect in sterile pouch seal, incomplete seal, of lighted Retractors, increases the risk of contamination, which can lead to post-operative infection.

Internal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It can cause a reduction in both staining intensity and the percent positivity, which could potentially lead to a false-negative PD-L1 result.

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.