Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
23,781 detailed records are currently available in this category.
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.
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
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…
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…
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.
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.
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…
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.
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.
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…
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
