Complete FDA and NHTSA recall records dated in January 2023.
These records include useful source details for the selected month.
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…
Blister package had an unsealed edge compromising sterility.
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.
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.
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…
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…
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.
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.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
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…
Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in…
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…
A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host Connectivity Agent (HCA) could occur where the order received from…
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.
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…
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
